Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6051567 Low oxygen content compositions of 1.alpha., 25-dihydroxycholecalciferol Claim Types: Formulation | FEB 02,2020 *PED | |
| Pat. No. 6265392 Low oxygen content compositions of 1.alpha., 25-dihydroxycholeclciferol Claim Types: Formulation | FEB 02,2020 *PED | |
| Pat. No. 6274169 Low oxygen content compostions of 1.alpha., 25-dihydroxycholecalciferol Claim Types: Process; Product-by-process | FEB 02,2020 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | May 16,2005 PED | M-14: Additional clinical trial information added to pediatric use subsection |
ABBOTT
DEPACON (INJECTABLE) VALPROATE SODIUM [GENERIC AP]
Drug Classes: ANTICONVULSANTS
NDA Applicant: ABBOTT NDA No.: 020593 Prod. No.: 001 RX (EQ 100MG BASE/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: D - New Dosing Schedule | JAN 24,2005 | D-72: Information regarding increased rate of infusion for DEPACON |
ABBOTT
DEPAKOTE (TABLET, DELAYED RELEASE) DIVALPROEX SODIUM
Drug Classes: ANTICONVULSANTS
NDA Applicant: ABBOTT NDA No.: 018723 Prod. No.: 001 RX (EQ 250MG VALPROIC ACID); 002 RX (EQ 500MG VALPROIC ACID); 003 RX (EQ 125MG VALPROIC ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4988731 Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 | |
| Pat. No. 5212326 Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 |
ABBOTT
DEPAKOTE (CAPSULE, DELAYED REL PELLETS) DIVALPROEX SODIUM
Drug Classes: ANTICONVULSANTS
NDA Applicant: ABBOTT NDA No.: 019680 Prod. No.: 001 RX (EQ 125MG VALPROIC ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4988731 Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 | |
| Pat. No. 5212326 Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 |
ABBOTT
DEPAKOTE CP (TABLET, DELAYED RELEASE) DIVALPROEX SODIUM
NDA Applicant: ABBOTT NDA No.: 019794 Prod. No.: 001 DISC (EQ 250MG BASE); 002 DISC (EQ 500MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4988731 Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 | |
| Pat. No. 5212326 Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 |
ABBOTT
DEPAKOTE ER (TABLET, EXTENDED RELEASE) DIVALPROEX SODIUM
NDA Applicant: ABBOTT NDA No.: 021168 Prod. No.: 001 RX (EQ 500MG VALPROIC ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4913906 Novel controlled release dosage form of valproic acid Claim Types: Formulation; Process | APR 03,2007 | |
| Pat. No. 4988731 Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 | |
| Pat. No. 5212326 DS* DP* Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 | |
| Pat. No. 6419953 Controlled release formulation of divalproex sodium Claim Types: Formulation; Process; Method of use | DEC 18,2018 | |
| Pat. No. 6511678 Controlled release formulation of divalproex sodium Claim Types: Formulation; Method of use | DEC 18,2018 | |
| Pat. No. 6528090 DP* Controlled release formulation of divalproex sodium Claim Types: Formulation | DEC 18,2018 | |
| Pat. No. 6528091 Controlled release formulation of divalproex sodium Claim Types: Method of use | DEC 18,2018 | U-106: Treatment of epilepsy |
| Pat. No. 6713086 DP* Controlled release formulation of divalproex sodium Claim Types: Formulation; Method of use | DEC 18,2018 | U-579: Treatment of epilepsy and/or migraine. |
| Pat. No. 6720004 DP* Controlled release formulation of divalproex sodium Claim Types: Formulation | DEC 18,2018 |
ABBOTT
DEPAKOTE ER (TABLET, EXTENDED RELEASE) DIVALPROEX SODIUM
NDA Applicant: ABBOTT NDA No.: 021168 Prod. No.: 002 RX (EQ 250MG VALPROIC ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4913906 Novel controlled release dosage form of valproic acid Claim Types: Formulation; Process | APR 03,2007 | |
| Pat. No. 4988731 Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 | |
| Pat. No. 5212326 DS* DP* Sodium hydrogen divalproate oligomer Claim Types: Composition | JAN 29,2008 | |
| Pat. No. 6511678 Controlled release formulation of divalproex sodium Claim Types: Formulation; Method of use | DEC 18,2018 | |
| Pat. No. 6528090 DP* Controlled release formulation of divalproex sodium Claim Types: Formulation | DEC 18,2018 | |
| Pat. No. 6713086 DP* Controlled release formulation of divalproex sodium Claim Types: Formulation; Method of use | DEC 18,2018 | U-579: Treatment of epilepsy and/or migraine. |
| Pat. No. 6720004 DP* Controlled release formulation of divalproex sodium Claim Types: Formulation | DEC 18,2018 |
ABBOTT
HYTRIN (TABLET) TERAZOSIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; DIURETICS
NDA Applicant: ABBOTT NDA No.: 019057 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 5MG BASE); 004 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5212176 R(+)-terazosin Claim Types: Compound; Composition; Method of use | JUN 29,2010 | |
| Pat. No. 5294615 Terazosin polymorph and pharmaceutical composition Claim Types: New polymorph, salt or hydrate; Composition; Method of use | APR 29,2013 | U-165: Treatment of symptomatic benign prostatic hyperplasia |
| Pat. No. 5294615 Terazosin polymorph and pharmaceutical composition Claim Types: New polymorph, salt or hydrate; Composition; Method of use | APR 29,2013 | U-3: Treatment of hypertension |
| Pat. No. 5412095 Terazosin monohydrochloride and processes and intermediate for its production Claim Types: New polymorph, salt or hydrate | APR 29,2013 |
ABBOTT
HYTRIN (CAPSULE) TERAZOSIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ALPHA AGONISTS/ALPHA BLOCKERS
NDA Applicant: ABBOTT NDA No.: 020347 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 5MG BASE); 004 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5212176 R(+)-terazosin Claim Types: Compound; Composition; Method of use | JUN 29,2010 | |
| Pat. No. 5294615 Terazosin polymorph and pharmaceutical composition Claim Types: New polymorph, salt or hydrate; Composition; Method of use | APR 29,2013 | U-165: Treatment of symptomatic benign prostatic hyperplasia |
| Pat. No. 5294615 Terazosin polymorph and pharmaceutical composition Claim Types: New polymorph, salt or hydrate; Composition; Method of use | APR 29,2013 | U-3: Treatment of hypertension |
| Pat. No. 5412095 Terazosin monohydrochloride and processes and intermediate for its production Claim Types: New polymorph, salt or hydrate | APR 29,2013 |
ABBOTT
KALETRA (CAPSULE) LOPINAVIR; RITONAVIR
Drug Classes: ANTIVIRALS
NDA Applicant: ABBOTT NDA No.: 021226 Prod. No.: 001 RX (133.3MG;33.3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5541206 Retroviral protease inhibiting compounds Claim Types: Compound; Composition; Method of use | JUL 30,2013 | U-348: Method of use for inhibiting HIV infection |
| Pat. No. 5635523 Retroviral protease inhibiting compounds Claim Types: Method of use | JUN 30,2014 | U-352: Inhibiting HIV infection by administering ritonavir in combination with a reverse transcriptase inhibitor |
| Pat. No. 5648497 Retroviral protease inhibiting compounds Claim Types: Compound | JUL 15,2014 | |
| Pat. No. 5674882 Retroviral protease inhibiting compounds Claim Types: Method of use | OCT 07,2014 | U-344: Method for inhibiting HIV infection by administering ritonavir in combination with another HIV protease inhibitor |
| Pat. No. 5846987 Retroviral protease inhibiting compounds Claim Types: Composition; Use of compound to prepare a composition | DEC 29,2012 | U-350: Preparation of a pharmaceutical composition for concomitant admin with a reverse transcriptase inhibitor |
| Pat. No. 5886036 Retroviral protease inhibiting compounds Claim Types: Composition | DEC 29,2012 | U-345: Ritonavir and another HIV protease inhibitor for concomitant administration for the treatment of an HIV infection |
| Pat. No. 5914332 Retroviral protease inhibiting compounds Claim Types: Compound; Composition; Method of use | DEC 13,2015 | U-351: Inhibiting protease with lopinavir and inhibiting an HIV infection with lopinavir |
| Pat. No. 6037157 Method for improving pharmacokinetics Claim Types: Method of use | JUN 26,2016 | U-346: Method for inhibiting cytochrome p450 monooxygenase with ritonavir and a method for improving the pharmcokinetics of a drug that is metabolized by cytochrome P450 monooxygenase by admin the drug and RITONAVIR |
| Pat. No. 6232333 Pharmaceutical composition Claim Types: Formulation | NOV 07,2017 | |
| Pat. No. 6284767 Retroviral protease inhibiting compounds Claim Types: Composition; Method of use | FEB 14,2016 | U-401: Use of lopinavir in combination with reverse transcriptase inhibitors for treating HIV infection and in combo with other HIV protease inhibitors |
| Pat. No. 6458818 Pharmaceutical composition Claim Types: Formulation | NOV 07,2017 | |
| Pat. No. 6521651 Pharmaceutical composition Claim Types: Formulation | NOV 01,2017 | |
| Pat. No. 6703403 Method for improving pharmacokinetics Claim Types: Method of improving a treatment | JUN 26,2016 | U-257: Treatment of HIV infection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | APR 29,2008 | D-99: Once daily administration for the treatment of HIV infection in therapy naive adult patients |
ABBOTT
KALETRA (SOLUTION) LOPINAVIR; RITONAVIR
NDA Applicant: ABBOTT NDA No.: 021251 Prod. No.: 001 RX (80MG/ML;20MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5541206 Retroviral protease inhibiting compounds Claim Types: Compound; Composition; Method of use | JUL 30,2013 | U-348: Method of use for inhibiting HIV infection |
| Pat. No. 5635523 Retroviral protease inhibiting compounds Claim Types: Method of use | JUN 03,2014 | U-352: Inhibiting HIV infection by administering ritonavir in combination with a reverse transcriptase inhibitor |
| Pat. No. 5648497 Retroviral protease inhibiting compounds Claim Types: Compound | JUL 15,2014 | |
| Pat. No. 5674882 Retroviral protease inhibiting compounds Claim Types: Method of use | OCT 07,2014 | U-344: Method for inhibiting HIV infection by administering ritonavir in combination with another HIV protease inhibitor |
| Pat. No. 5846987 Retroviral protease inhibiting compounds Claim Types: Composition; Use of compound to prepare a composition | DEC 29,2012 | U-350: Preparation of a pharmaceutical composition for concomitant admin with a reverse transcriptase inhibitor |
| Pat. No. 5886036 Retroviral protease inhibiting compounds Claim Types: Composition | DEC 29,2012 | U-345: Ritonavir and another HIV protease inhibitor for concomitant administration for the treatment of an HIV infection |
| Pat. No. 5914332 Retroviral protease inhibiting compounds Claim Types: Compound; Composition; Method of use | DEC 13,2005 | U-351: Inhibiting protease with lopinavir and inhibiting an HIV infection with lopinavir |
| Pat. No. 6037157 Method for improving pharmacokinetics Claim Types: Method of use | JUN 26,2016 | U-346: Method for inhibiting cytochrome p450 monooxygenase with ritonavir and a method for improving the pharmcokinetics of a drug that is metabolized by cytochrome P450 monooxygenase by admin the drug and RITONAVIR |
| Pat. No. 6284767 Retroviral protease inhibiting compounds Claim Types: Composition; Method of use | FEB 14,2016 | U-401: Use of lopinavir in combination with reverse transcriptase inhibitors for treating HIV infection and in combo with other HIV protease inhibitors |
| Pat. No. 6703403 Method for improving pharmacokinetics Claim Types: Method of improving a treatment | JUN 26,2016 | U-257: Treatment of HIV infection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | APR 29,2008 | D-99: Once daily administration for the treatment of HIV infection in therapy naive adult patients |
ABBOTT
MAVIK (TABLET) TRANDOLAPRIL
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: ABBOTT NDA No.: 020528 Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (4MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4933361 Derivatives of bicyclic aminoacids agents containing these compounds and their use Claim Types: Compound; Composition; Method of use | JUN 12,2007 | |
| Pat. No. 5744496 Method of treating cardiac insufficiency using angiotensin-converting enzyme inhibitors Claim Types: Method of use | APR 28,2015 | U-229: Cardiac insufficiency (congestive heart failure) |
ABBOTT
MERIDIA (CAPSULE) SIBUTRAMINE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS; CNS, MISCELLANEOUS
NDA Applicant: ABBOTT NDA No.: 020632 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4746680 [Extended 5 years] Therapeutic agents Claim Types: Compound; Composition; Method of use | DEC 11,2007 *PED | |
| Pat. No. 4929629 Therapeutic compound Claim Types: Compound; Composition; Method of use | NOV 29,2007 *PED | |
| Pat. No. 5436272 Treatment of obesity Claim Types: Method of use | JAN 25,2013 *PED | U-439: Treatment of obesity |
ABBOTT
MIVACRON; MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER (INJECTABLE) MIVACURIUM CHLORIDE
NDA Applicant: ABBOTT NDA No.: 020098 Prod. No.: 001 RX (EQ 2MG BASE/ML) NDA No.: 020098 Prod. No.: 002 DISC (EQ 0.5MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4761418 [Extended 173 days (0.5 years)] Novel compounds Claim Types: Compound; Composition; Method of use | JAN 22,2006 |
ABBOTT
NIMBEX; NIMBEX PRESERVATIVE FREE (INJECTABLE) CISATRACURIUM BESYLATE
Drug Classes: ANESTHESIA, ADJUNCTS TO/ANALEPTICS
NDA Applicant: ABBOTT NDA No.: 020551 Prod. No.: 001 RX (EQ 2MG BASE/ML); 002 RX (EQ 10MG BASE/ML); 003 RX (EQ 2MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5453510 Neuromuscular blocking agents Claim Types: Formulation; Method of use | SEP 26,2012 | U-127: Method of producing neuromuscular blockade |
ABBOTT
NORVIR (SOLUTION) RITONAVIR
Drug Classes: ANTIVIRALS
NDA Applicant: ABBOTT NDA No.: 020659 Prod. No.: 001 RX (80MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5484801 Pharmaceutical composition for inhibiting HIV protease Claim Types: Formulation | JAN 28,2014 | |
| Pat. No. 5541206 Retroviral protease inhibiting compounds Claim Types: Compound; Composition; Method of use | JUL 30,2013 | U-140: Use of NORVIR to inhibit HIV protease or to inhibit an HIV infection |
| Pat. No. 5635523 Retroviral protease inhibiting compounds Claim Types: Method of use | JUN 03,2014 | U-190: Use of ritonavir in combination with any reverse transcriptase inhibitor |
| Pat. No. 5648497 Retroviral protease inhibiting compounds Claim Types: Compound | JUL 15,2014 | |
| Pat. No. 5674882 Retroviral protease inhibiting compounds Claim Types: Method of use | OCT 07,2014 | |
| Pat. No. 5846987 Retroviral protease inhibiting compounds Claim Types: Composition; Use of compound to prepare a composition | DEC 29,2012 | U-190: Use of ritonavir in combination with any reverse transcriptase inhibitor |
| Pat. No. 5886036 Retroviral protease inhibiting compounds Claim Types: Composition | DEC 29,2012 | |
| Pat. No. 6037157 Method for improving pharmacokinetics Claim Types: Method of use | JUN 26,2016 | |
| Pat. No. 6703403 Method for improving pharmacokinetics Claim Types: Method of improving a treatment | JUN 26,2016 | U-564: Treatment of HIV in concomitant therapy |
ABBOTT
NORVIR (CAPSULE) RITONAVIR
Drug Classes: ANTIVIRALS
NDA Applicant: ABBOTT NDA No.: 020680 Prod. No.: 001 DISC (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5541206 Retroviral protease inhibiting compounds Claim Types: Compound; Composition; Method of use | JUL 30,2013 | U-140: Use of NORVIR to inhibit HIV protease or to inhibit an HIV infection |
| Pat. No. 5635523 Retroviral protease inhibiting compounds Claim Types: Method of use | JUN 03,2014 | U-190: Use of ritonavir in combination with any reverse transcriptase inhibitor |
| Pat. No. 5648497 Retroviral protease inhibiting compounds Claim Types: Compound | JUL 15,2014 | |
| Pat. No. 5846987 Retroviral protease inhibiting compounds Claim Types: Composition; Use of compound to prepare a composition | DEC 29,2012 | U-190: Use of ritonavir in combination with any reverse transcriptase inhibitor |
| Pat. No. 5948436 Pharmaceutical composition Claim Types: Formulation | SEP 13,2013 |
ABBOTT
NORVIR (CAPSULE) RITONAVIR
Drug Classes: ANTIVIRALS
NDA Applicant: ABBOTT NDA No.: 020945 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5541206 Retroviral protease inhibiting compounds Claim Types: Compound; Composition; Method of use | JUL 30,2013 | U-348: Method of use for inhibiting HIV infection |
| Pat. No. 5635523 Retroviral protease inhibiting compounds Claim Types: Method of use | JUN 03,2014 | U-347: Method of use in combination with reverse transcriptase inhibitors |
| Pat. No. 5648497 Retroviral protease inhibiting compounds Claim Types: Compound | JUL 15,2014 | |
| Pat. No. 5846987 Retroviral protease inhibiting compounds Claim Types: Composition; Use of compound to prepare a composition | DEC 29,2012 | U-347: Method of use in combination with reverse transcriptase inhibitors |
| Pat. No. 6232333 Pharmaceutical composition Claim Types: Formulation | NOV 07,2017 | |
| Pat. No. 6703403 Method for improving pharmacokinetics Claim Types: Method of improving a treatment | JUN 26,2016 | U-564: Treatment of HIV in concomitant therapy |
ABBOTT
NUROMAX (INJECTABLE) DOXACURIUM CHLORIDE
NDA Applicant: ABBOTT NDA No.: 019946 Prod. No.: 001 DISC (EQ 1MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4701460 [Extended 137 days (0.4 years)] Long duration neuromuscular blocking agents Claim Types: Compound; Method of use; Composition | MAR 06,2005 |
ABBOTT
TARKA (TABLET, EXTENDED RELEASE) TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: ABBOTT NDA No.: 020591 Prod. No.: 001 RX (2MG;180MG); 002 RX (4MG;240MG); 003 RX (1MG;240MG); 004 RX (2MG;240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4933361 Derivatives of bicyclic aminoacids agents containing these compounds and their use Claim Types: Compound; Composition; Method of use | JUN 12,2007 | |
| Pat. No. 5721244 Combination of angiotensin-converting enzyme inhibitors with calcium antagonists as well as their use in drugs Claim Types: Composition; Method of use | FEB 24,2015 |
ABBOTT
TRICOR (TABLET) FENOFIBRATE [GENERIC AB]
Drug Classes: HYPERLIPIDEMIA
NDA Applicant: ABBOTT NDA No.: 021203 Prod. No.: 001 RX (54MG); 003 RX (160MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4895726 Novel dosage form of fenofibrate Claim Types: Formulation; Method of use; Process | JAN 19,2009 | |
| Pat. No. 6074670 Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it Claim Types: Formulation | JAN 09,2018 | |
| Pat. No. 6277405 Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it Claim Types: Formulation | JAN 09,2018 | |
| Pat. No. 6589552 Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it Claim Types: Formulation | JAN 09,2018 | |
| Pat. No. 6652881 DP* Fenofibrate pharmaceutical composition having high bioavailability Claim Types: Formulation | JAN 09,2018 |
ABBOTT
TRICOR (TABLET) FENOFIBRATE
NDA Applicant: ABBOTT NDA No.: 021656 Prod. No.: 001 RX (48MG); 002 RX (145MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5145684 DP* Surface modified drug nanoparticles Claim Types: Composition; Method of use; Process | JAN 25,2011 | U-615: Adjunctive therapy to diet in adults to reduce LDL-c, total-c, triglycerides and APO B, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V) |
| Pat. No. 6277405 DS* Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it Claim Types: Formulation | JAN 09,2018 | |
| Pat. No. 6375986 DP* Solid dose nanoparticulate compositions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate Claim Types: Formulation; Process; Method of use | SEP 21,2020 | U-615: Adjunctive therapy to diet in adults to reduce LDL-c, total-c, triglycerides and APO B, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V) |
| Pat. No. 6652881 DS* Fenofibrate pharmaceutical composition having high bioavailability Claim Types: Formulation | JAN 09,2018 |
ABBOTT
TRICOR (MICRONIZED) (CAPSULE) FENOFIBRATE [Has competitive generic]
Drug Classes: HYPERLIPIDEMIA
NDA Applicant: ABBOTT NDA No.: 019304 Prod. No.: 002 DISC (67MG); 003 DISC (134MG); 004 DISC (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4895726 Novel dosage form of fenofibrate Claim Types: Formulation; Method of use; Process | JAN 19,2009 |
ABBOTT
ULTANE (LIQUID) SEVOFLURANE [GENERIC AN]
Drug Classes: ANESTHETICS, GENERAL
NDA Applicant: ABBOTT NDA No.: 020478 Prod. No.: 001 RX (100%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5990176 Fluoroether compositions and methods for inhibiting their degradation in the presence of a Lewis acid Claim Types: Formulation; Method of improving a formulation | JUL 27,2017 *PED | |
| Pat. No. 6074668 Container for an inhalation anesthetic Claim Types: Drug in a container | JUL 09,2018 *PED | |
| Pat. No. 6288127 Fluoroether compositions and methods for inhibiting their degradation in the presence of a Lewis acid Claim Types: Formulation; Method of improving a formulation | JUL 27,2017 *PED | |
| Pat. No. 6444859 Fluoroether compositions and methods for inhibiting their degradation in the presence of a Lewis acid Claim Types: Method of improving a formulation; Product-by-process | JUL 27,2017 *PED |
ABBOTT
ULTIVA (INJECTABLE) REMIFENTANIL HYDROCHLORIDE
NDA Applicant: ABBOTT NDA No.: 020630 Prod. No.: 001 RX (EQ 1MG BASE/VIAL); 002 RX (EQ 2MG BASE/VIAL); 003 RX (EQ 5MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5019583 [Extended 512 days (1.4 years)] N-phenyl-N-(4-piperidinyl)amides useful as analgesics Claim Types: Compound; Composition; Method of use | AUG 15,2009 *PED | |
| Pat. No. 5466700 Anesthetic use of N-phenyl-N-(4-piperidinyl)amides Claim Types: Method of use | MAR 01,2014 *PED | U-156: Method of providing anesthesia |
ABBOTT
VICOPROFEN (TABLET) HYDROCODONE BITARTRATE; IBUPROFEN [GENERIC AB]
Drug Classes: ANALGESICS-NARCOTIC; NSAID; ANTITUSSIVES/EXPECTORANTS/MUCOLYTICS
NDA Applicant: ABBOTT NDA No.: 020716 Prod. No.: 001 RX (7.5MG;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6348216 Ibuprofen and narcotic analgesic compositions Claim Types: Formulation | JUN 10,2017 | |
| Pat. No. 6599531 Method of making ibuprofen and narcotic analgesic compositions Claim Types: Product-by-process | JUN 10,2017 |
ABBOTT
ZEMPLAR (INJECTABLE) PARICALCITOL
Drug Classes: VITAMINS/MINERALS
NDA Applicant: ABBOTT NDA No.: 020819 Prod. No.: 001 RX (0.005MG/ML); 002 RX (0.002MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5246925 [Extended 574 days (1.6 years)] 19-nor-vitamin D compounds for use in treating hyperparathyroidism Claim Types: Method of use | OCT 17,2012 *PED | U-314: Method for treating hyperparathyroidism which comprises suppressing parathyroid activity |
| Pat. No. 5587497 19-nor-vitamin D compounds Claim Types: Compound | JUN 24,2014 *PED | |
| Pat. No. 6136799 Cosolvent formulations Claim Types: Formulation; Process | OCT 08,2019 *PED | |
| Pat. No. 6361758 DP* Cosolvent formulations Claim Types: Formulation | OCT 08,2018 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 01,2007 PED | M-31: Information for use in pediatric patients with chronic kidney disease Stage 5 (end-stage renal disease) |
ABBOTT
ZEMPLAR (CAPSULE) PARICALCITOL
NDA Applicant: ABBOTT NDA No.: 021606 Prod. No.: 001 RX (1UGM); 002 RX (2UGM); 003 RX (4UGM)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NDF - New dosage form | MAY 26,2008 |
ACCESS PHARMS
AMLEXANOX (PATCH) AMLEXANOX
NDA Applicant: ACCESS PHARMS NDA No.: 021727 Prod. No.: 001 RX (2MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NDF - New dosage form | SEP 29,2007 |
ACCESS PHARMS
APHTHASOL (PASTE) AMLEXANOX
Drug Classes: DENTAL PREPARATIONS
NDA Applicant: ACCESS PHARMS NDA No.: 020511 Prod. No.: 001 RX (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5362737 Methods of treating aphthous ulcers and other mucocutaneous disorders with amlexanox Claim Types: Method of use | NOV 08,2011 | U-243: Topical administration |
ACORDA
ZANAFLEX (CAPSULE) TIZANIDINE HYDROCHLORIDE
NDA Applicant: ACORDA NDA No.: 021447 Prod. No.: 001 RX (EQ 2MG BASE); 002 RX (EQ 4MG BASE); 003 RX (EQ 6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6455557 Method of reducing somnolence in patients treated with tizanidine Claim Types: Method of improving a treatment | NOV 28,2021 |
ACTELION
TRACLEER (TABLET) BOSENTAN
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: ACTELION NDA No.: 021290 Prod. No.: 001 RX (62.5MG); 002 RX (125MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5292740 Sulfonamides Claim Types: Compound; Composition; Method of use | NOV 20,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | NOV 20,2006 | |
| Exclusivity Code ODE: Orphan Drug | NOV 20,2008 | Treatment of pulmonary arterial hypertension. |
ACTELION PHARMS
ZAVESCA (CAPSULE) MIGLUSTAT
NDA Applicant: ACTELION PHARMS NDA No.: 021348 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5472969 Method of inhibiting glycolipid synthesis Claim Types: Method of use | MAY 13,2013 | |
| Pat. No. 5525616 Method of inhibiting glycolipid synthesis Claim Types: Method of use | JUN 11,2013 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | JUL 31,2008 | |
| Exclusivity Code ODE: Orphan Drug | JUL 31,2010 | Use of Zavesca (miglustat) for the treatment of mild to moderate Type I Gaucher disease in adults for whom enzyme replacement therapy is not a therapeutic option (e.g., due to constraints such as allergy, hypersensitivity, or poor venous access)(Summarized from Approval Letter). |
ADAMS LABS INC
MUCINEX (TABLET, EXTENDED RELEASE) GUAIFENESIN
NDA Applicant: ADAMS LABS INC NDA No.: 021282 Prod. No.: 001 OTC (600MG); 002 OTC (1.2GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6372252 Guaifenesin sustained release formulation and tablets Claim Types: Formulation | APR 28,2020 | U-489: Expectorant |
ADAMS LABS INC
MUCINEX D (TABLET, EXTENDED RELEASE) GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: ADAMS LABS INC NDA No.: 021585 Prod. No.: 001 OTC (600MG;60MG); 002 OTC (1.2GM;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6372252 DP* Guaifenesin sustained release formulation and tablets Claim Types: Formulation | APR 28,2020 |
ADAMS LABS INC
MUCINEX DM (TABLET, EXTENDED RELEASE) DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
NDA Applicant: ADAMS LABS INC NDA No.: 021620 Prod. No.: 001 OTC (60MG;1.2GM); 002 OTC (30MG;600MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6372252 DP* Guaifenesin sustained release formulation and tablets Claim Types: Formulation | APR 28,2020 |
ADV MAGNETICS
FERIDEX I.V. (INJECTABLE) FERUMOXIDES
Drug Classes: DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE
NDA Applicant: ADV MAGNETICS NDA No.: 020416 Prod. No.: 001 RX (EQ 11.2MG IRON/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4770183 Biologically degradable superparamagnetic particles for use as nuclear magnetic resonance imaging agents Claim Types: Method of use | SEP 13,2005 | U-145: Biologically degradable superparamagnetic particles for use as nuclear magnetic resonance imaging agents |
| Pat. No. 4827945 Biologically degradable superparamagnetic materials for use in clinical applications Claim Types: Diagnostic or surgical method; Method of use | MAY 09,2006 | U-144: Biologically degradable superparamagnetic materials for use in clinical applications |
| Pat. No. 4951675 Biodegradable superparamagnetic metal oxides as contrast agents for MR imaging Claim Types: Diagnostic or surgical method | AUG 28,2007 | U-143: Biodegradable superparamagnetic metal oxides as contrast agents for mr imaging |
| Pat. No. 5055288 Vascular magnetic imaging method and agent comprising biodegradeable superparamagnetic metal oxides Claim Types: Composition | OCT 08,2008 | |
| Pat. No. 5102652 Low molecular weight carbohydrates as additives to stabilize metal oxide compositions Claim Types: Formulation; Diagnostic or surgical method; Method of use; Process | FEB 06,2009 | |
| Pat. No. 5219554 Hydrated biodegradable superparamagnetic metal oxides Claim Types: Composition | JUN 15,2010 | |
| Pat. No. 5248492 Low molecular weight carbohydrates as additives to stabilize metal oxide compositions Claim Types: Formulation; Diagnostic or surgical method; Method of use; Method of improving a formulation | SEP 28,2010 |
ADV MAGNETICS
GASTROMARK (SUSPENSION) FERUMOXSIL
Drug Classes: DIAGNOSTICS, MISCELLANEOUS
NDA Applicant: ADV MAGNETICS NDA No.: 020410 Prod. No.: 001 RX (EQ 0.175MG IRON/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4770183 Biologically degradable superparamagnetic particles for use as nuclear magnetic resonance imaging agents Claim Types: Method of use | SEP 13,2005 | U-169: Methods of using the compound/drug product as a contrast agent in magnetic resonance imaging |
| Pat. No. 4827945 Biologically degradable superparamagnetic materials for use in clinical applications Claim Types: Diagnostic or surgical method; Method of use | MAY 09,2006 | U-170: Method of obtaining an mr image using the composition/drug product as a contrast agent |
| Pat. No. 4951675 Biodegradable superparamagnetic metal oxides as contrast agents for MR imaging Claim Types: Diagnostic or surgical method | SEP 13,2005 | U-169: Methods of using the compound/drug product as a contrast agent in magnetic resonance imaging |
| Pat. No. 5055288 Vascular magnetic imaging method and agent comprising biodegradeable superparamagnetic metal oxides Claim Types: Composition | OCT 08,2008 | |
| Pat. No. 5069216 Silanized biodegradable super paramagnetic metal oxides as contrast agents for imaging the gastrointestinal tract Claim Types: Diagnostic or surgical method | MAY 09,2006 | U-171: Methods of using the compound/drug product as an oral contrast agent in magnetic resonance imaging of the gastrointestinal tract |
| Pat. No. 5219554 Hydrated biodegradable superparamagnetic metal oxides Claim Types: Composition | JUN 15,2010 |
AGIS INDS
MOMETASONE FUROATE (LOTION) MOMETASONE FUROATE [GENERIC AB]
NDA Applicant: AGIS INDS NDA No.: 077180 Prod. No.: 001 RX (0.1%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | NOV 19,2005 |
AGOURON
RESCRIPTOR (TABLET) DELAVIRDINE MESYLATE
Drug Classes: ANTIVIRALS
NDA Applicant: AGOURON NDA No.: 020705 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5563142 Diaromatic substituted compounds as anti-HIV-1 agents Claim Types: Compound | OCT 08,2013 |
AGOURON
RESCRIPTOR (TABLET) DELAVIRDINE MESYLATE
Drug Classes: ANTIVIRALS
NDA Applicant: AGOURON NDA No.: 020705 Prod. No.: 002 RX (200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5563142 Diaromatic substituted compounds as anti-HIV-1 agents Claim Types: Compound | OCT 08,2013 | |
| Pat. No. 6177101 Delavirdine high strength tablet formulation Claim Types: Formulation | JUN 07,2019 |
AGOURON
VIRACEPT (FOR SUSPENSION) NELFINAVIR MESYLATE
Drug Classes: ANTIVIRALS
NDA Applicant: AGOURON NDA No.: 020778 Prod. No.: 001 RX (EQ 50MG BASE/SCOOPFUL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5484926 HIV protease inhibitors Claim Types: Compound | APR 07,2014 *PED | |
| Pat. No. 5952343 HIV protease inhibitors Claim Types: Compound; Composition; Method of use | APR 07,2014 *PED | U-257: Treatment of HIV infection |
| Pat. No. 6162812 Pharmaceutical compositions containing HIV protease inhibitors and methods of their use Claim Types: Composition; Method of use | APR 07,2014 *PED | U-248: Treatment of HIV |
AGOURON
VIRACEPT (TABLET) NELFINAVIR MESYLATE
Drug Classes: ANTIVIRALS
NDA Applicant: AGOURON NDA No.: 020779 Prod. No.: 001 RX (EQ 250MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5484926 HIV protease inhibitors Claim Types: Compound | APR 07,2014 *PED | |
| Pat. No. 5952343 HIV protease inhibitors Claim Types: Compound; Composition; Method of use | APR 07,2014 *PED | U-257: Treatment of HIV infection |
| Pat. No. 6162812 Pharmaceutical compositions containing HIV protease inhibitors and methods of their use Claim Types: Composition; Method of use | APR 07,2014 *PED | U-248: Treatment of HIV |
AGOURON
VIRACEPT (TABLET) NELFINAVIR MESYLATE
NDA Applicant: AGOURON NDA No.: 021503 Prod. No.: 001 RX (EQ 625MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5484926 HIV protease inhibitors Claim Types: Compound | APR 07,2014 *PED | |
| Pat. No. 5952343 HIV protease inhibitors Claim Types: Compound; Composition; Method of use | APR 07,2014 *PED | U-257: Treatment of HIV infection |
| Pat. No. 6162812 Pharmaceutical compositions containing HIV protease inhibitors and methods of their use Claim Types: Composition; Method of use | APR 07,2014 *PED | U-248: Treatment of HIV |
ALARA PHARM
LEVO-T (TABLET) LEVOTHYROXINE SODIUM [Has competitive generic]
Drug Classes: THYROID/ANTITHYROID
NDA Applicant: ALARA PHARM NDA No.: 021342 Prod. No.: 001 RX (0.025MG **See Current Cumulative Supplement 1.3); 002 RX (0.05MG **See Current Cumulative Supplement 1.3); 003 RX (0.075MG **See Current Cumulative Supplement 1.3); 004 RX (0.088MG **See Current Cumulative Supplement 1.3); 005 RX (0.1MG **See Current Cumulative Supplement 1.3); 006 RX (0.112MG **See Current Cumulative Supplement 1.3); 007 RX (0.125MG **See Current Cumulative Supplement 1.3); 008 RX (0.15MG **See Current Cumulative Supplement 1.3); 009 RX (0.175MG **See Current Cumulative Supplement 1.3); 010 RX (0.2MG **See Current Cumulative Supplement 1.3); 011 RX (0.3MG **See Current Cumulative Supplement 1.3)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6399101 Stable thyroid hormone preparations and method of making same Claim Types: Formulation; Process | MAR 30,2020 |
ALCON
ALOMIDE (SOLUTION/DROPS) LODOXAMIDE TROMETHAMINE
Drug Classes: OPHTHALMICS, MISCELLANEOUS
NDA Applicant: ALCON NDA No.: 020191 Prod. No.: 001 RX (EQ 0.1% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5457126 Use of lodoxamide to treat ophthalmic allergic conditions Claim Types: Method of use | OCT 10,2012 | U-117: Treatment of ocular allergic response in human eyes |
ALCON
AZOPT (SUSPENSION/DROPS) BRINZOLAMIDE
Drug Classes: GLAUCOMA
NDA Applicant: ALCON NDA No.: 020816 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5240923 Sulfonamides useful as carbonic anhydrase inhibitors Claim Types: Compound; Formulation; Method of use | AUG 31,2010 | U-224: Controlling intraocular pressure |
| Pat. No. 5378703 [Extended 723 days (2 years)] Sulfonamides useful as carbonic anhydrase inhibitors Claim Types: Compound; Composition; Method of use | APR 01,2012 | U-224: Controlling intraocular pressure |
| Pat. No. 5461081 Topical ophthalmic pharmaceutical vehicles Claim Types: Excipient; Method of administration | OCT 24,2012 | U-225: Method for delivery |
ALCON
BETAXON (SUSPENSION/DROPS) LEVOBETAXOLOL HYDROCHLORIDE
NDA Applicant: ALCON NDA No.: 021114 Prod. No.: 001 DISC (EQ 0.5% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4911920 Sustained release, comfort formulation for glaucoma therapy Claim Types: Formulation; Method of use | MAR 27,2007 | U-369: Method of controlling and lowering intraocular pressure |
| Pat. No. 5540918 Use of certain anionic surfactants to enhance antimicrobial effectiveness of ophthalmic compositions Claim Types: Formulation | JUL 30,2013 |
ALCON
BETOPTIC PILO (SUSPENSION/DROPS) BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE
NDA Applicant: ALCON NDA No.: 020619 Prod. No.: 001 DISC (EQ 0.25% BASE;1.75%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5635172 Sustained release comfort formulation for glaucoma therapy Claim Types: Formulation; Method of use | JUN 03,2014 | U-191: Method of treatment for controlling and lowering intraocular pressure in a human |
ALCON
BETOPTIC S (SUSPENSION/DROPS) BETAXOLOL HYDROCHLORIDE
Drug Classes: GLAUCOMA
NDA Applicant: ALCON NDA No.: 019845 Prod. No.: 001 RX (EQ 0.25% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4911920 Sustained release, comfort formulation for glaucoma therapy Claim Types: Formulation; Method of use | MAR 27,2007 |
ALCON
CIPRO HC (SUSPENSION/DROPS) CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS; TOPICAL STEROIDS; OTICS, TOPICAL
NDA Applicant: ALCON NDA No.: 020805 Prod. No.: 001 RX (EQ 0.2% BASE;1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4844902 DP* Topically applicable formulations of gyrase inhibitors in combination with corticosteroids Claim Types: Formulation | FEB 11,2008 | |
| Pat. No. 5843930 Method of treating otitis with ciprofloxacin-hydrocortisone suspension Claim Types: Method of use | JUL 06,2015 | U-646: Method of treating otitis |
| Pat. No. 5965549 DP* Ciprofloxacin-hydrocortisone suspension Claim Types: ; Formulation | JUN 06,2015 |
ALCON
CIPRODEX (SUSPENSION/DROPS) CIPROFLOXACIN; DEXAMETHASONE
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: ALCON NDA No.: 021537 Prod. No.: 001 RX (0.3%;0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4844902 Topically applicable formulations of gyrase inhibitors in combination with corticosteroids Claim Types: Formulation | FEB 11,2008 | |
| Pat. No. 6284804 Topical suspension formulations containing ciprofloxacin and dexamethasone Claim Types: Formulation | AUG 10,2020 | |
| Pat. No. 6359016 Topical suspension formulations containing ciprofloxacin and dexamethasone Claim Types: Formulation | AUG 10,2020 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | JUL 18,2006 |
ALCON
EMADINE (SOLUTION/DROPS) EMEDASTINE DIFUMARATE
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS
NDA Applicant: ALCON NDA No.: 020706 Prod. No.: 001 RX (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4430343 [Extended 1027 days (2.8 years)] Benzimidazole derivatives, process for the preparation thereof and pharmaceutical composition containing the same Claim Types: Compound; Composition | AUG 14,2005 | U-403: Anti-allergic for various allergic diseases |
| Pat. No. 5441958 Ophthalmic compositions comprising emedastine and methods for their use Claim Types: Method of use | DEC 08,2013 | U-404: Treatment of allergic conjunctivitis |
ALCON
IOPIDINE (SOLUTION/DROPS) APRACLONIDINE HYDROCHLORIDE
Drug Classes: OPHTHALMICS, MISCELLANEOUS
NDA Applicant: ALCON NDA No.: 019779 Prod. No.: 001 RX (EQ 1% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5212196 Control of post-surgical intraocular pressure using clonidine derivatives Claim Types: Method of use | MAY 18,2010 | U-120: Controlling or preventing post-operative intraocular pressure rises associated with ophthalmic laser surgical procedures |
ALCON
OLOPATADINE HYDROCHLORIDE (SOLUTION/DROPS) OLOPATADINE HYDROCHLORIDE
NDA Applicant: ALCON NDA No.: 021545 Prod. No.: 001 RX (0.2%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | DEC 22,2007 |
ALCON
PATANOL (SOLUTION/DROPS) OLOPATADINE HYDROCHLORIDE
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS
NDA Applicant: ALCON NDA No.: 020688 Prod. No.: 001 RX (EQ 0.1% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4871865 Tricyclic aromatic compounds Claim Types: Compound | OCT 03,2006 | |
| Pat. No. 4923892 Tricyclic aromatic compounds Claim Types: Composition; Method of use | MAY 08,2007 | U-174: Use as an antihistamine agent |
| Pat. No. 5116863 [Extended 571 days (1.6 years)] Dibenz[b,e]oxepin derivative and pharmaceutical compositions thereof Claim Types: Compound; Composition | DEC 18,2010 | |
| Pat. No. 5641805 Topical ophthalmic formulations for treating allergic eye diseases Claim Types: Method of use | JUN 06,2015 | U-184: Treating allergic eye diseases in humans |
ALCON
TRAVATAN (SOLUTION/DROPS) TRAVOPROST
Drug Classes: GLAUCOMA
NDA Applicant: ALCON NDA No.: 021257 Prod. No.: 001 RX (0.004%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5510383 DP* Use of cloprostenol, fluprostenol and their salts and esters to treat glaucoma and ocular hypertension Claim Types: Method of use; Composition | AUG 03,2013 | U-383: Method for treating glaucoma and ocular hypertension |
| Pat. No. 5631287 Storage-stable prostaglandin compositions Claim Types: Process | DEC 22,2014 | U-382: Method of stablizing prostaglandin |
| Pat. No. 5849792 DP* Storage-stable prostaglandin compositions Claim Types: Formulation; Method of use | DEC 22,2014 | U-383: Method for treating glaucoma and ocular hypertension |
| Pat. No. 5889052 DP* [Extended 486 days (1.3 years)] Use of cloprostenol and fluprostenol analogues to treat glaucoma and ocular hypertension Claim Types: Method of use; Formulation Comments: This patent was extended under Sec. 156; expiration date includes the extension | DEC 02,2014 | U-383: Method for treating glaucoma and ocular hypertension |
| Pat. No. 6011062 DP* Storage-stable prostaglandin compositions Claim Types: Formulation; Method of improving a formulation | DEC 22,2014 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | FEB 13,2006 | M-23: Information regarding elimination added to clinical pharmacology, study results in patients with hepatic and renal impairment |
| Exclusivity Code: NCE - New chemical entity | MAR 16,2006 |
ALCON
VEXOL (SUSPENSION/DROPS) RIMEXOLONE
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS; OCULAR ANTI-INFECTIVE/ANTI-INFLAMMATORY
NDA Applicant: ALCON NDA No.: 020474 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4686214 [Extended 996 days (2.7 years)] Anti-inflammatory compounds for ophthalmic use Claim Types: Method of use | JUL 22,2008 | U-100: Method of treating ocular inflammation |
ALCON
VIGAMOX (SOLUTION/DROPS) MOXIFLOXACIN HYDROCHLORIDE
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: ALCON NDA No.: 021598 Prod. No.: 001 RX (0.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4990517 [Extended 901 days (2.5 years)] 7-(1-pyrrolidinyl)-3-quinolone- and -naphthyridonecarboxylic acid derivatives as antibacterial agents and feed additives Claim Types: Compound; Composition; Method of use | DEC 30,2009 *PED | |
| Pat. No. 5607942 7-(1-pyrrolidinyl)-3-quinolone- and - naphthyridone-carboxylic acid derivatives as antibacterial agents and feed additives Claim Types: Compound; Composition; Method of use | SEP 04,2014 *PED | |
| Pat. No. 6716830 DP* Ophthalmic antibiotic compositions containing moxifloxacin Claim Types: Composition | MAR 29,2020 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 10,2005 PED | |
| Exclusivity Code: NDF - New dosage form | Oct 15,2006 PED |
ALLERGAN
ACULAR (SOLUTION/DROPS) KETOROLAC TROMETHAMINE
Drug Classes: OPHTHALMICS, MISCELLANEOUS; OCULAR ANTI-INFECTIVE/ANTI-INFLAMMATORY
NDA Applicant: ALLERGAN NDA No.: 019700 Prod. No.: 001 RX (0.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5110493 Ophthalmic NSAID formulations containing a quaternary ammonium preservative and a nonionic surfactant Claim Types: Formulation; Excipient | NOV 05,2009 *PED | U-75: Relief of ocular itching due to seasonal allergic conjunctivitis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | FEB 08,2005 | M-16: Change in wording of the pediatric section of the package insert |
ALLERGAN
ACULAR LS (SOLUTION/DROPS) KETOROLAC TROMETHAMINE
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: ALLERGAN NDA No.: 021528 Prod. No.: 001 RX (0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5110493 Ophthalmic NSAID formulations containing a quaternary ammonium preservative and a nonionic surfactant Claim Types: Formulation; Excipient | NOV 05,2009 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | MAY 30,2006 |
ALLERGAN
ACULAR PRESERVATIVE FREE (SOLUTION/DROPS) KETOROLAC TROMETHAMINE
Drug Classes: OCULAR ANTI-INFECTIVE/ANTI-INFLAMMATORY
NDA Applicant: ALLERGAN NDA No.: 020811 Prod. No.: 001 RX (0.5%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | FEB 08,2005 | M-16: Change in wording of the pediatric section of the package insert |
ALLERGAN
ALOCRIL (SOLUTION/DROPS) NEDOCROMIL SODIUM
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS
NDA Applicant: ALLERGAN NDA No.: 021009 Prod. No.: 001 RX (2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4474787 [Extended 5 years] 7,6 Dioxo-4H,6H-pyrano[3,2-g]quinoline dicarboxylic acids and anti-allergic use thereof Claim Types: Compound; Composition; Method of use | OCT 02,2006 | U-304: A method of treatment of a condition involving an antibody antigen reaction |
| Pat. No. RE38628 Pharmaceutical compositions Claim Types: Method of use | AUG 22,2012 | U-304: A method of treatment of a condition involving an antibody antigen reaction |
ALLERGAN
ALPHAGAN (SOLUTION/DROPS) BRIMONIDINE TARTRATE
NDA Applicant: ALLERGAN NDA No.: 020490 Prod. No.: 001 DISC (0.5%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Jun 20,2005 PED |
ALLERGAN
ALPHAGAN (SOLUTION/DROPS) BRIMONIDINE TARTRATE [Has competitive generic]
Drug Classes: GLAUCOMA
NDA Applicant: ALLERGAN NDA No.: 020613 Prod. No.: 001 DISC (0.2%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Jun 20,2005 PED |
ALLERGAN
ALPHAGAN P (SOLUTION/DROPS) BRIMONIDINE TARTRATE
Drug Classes: GLAUCOMA
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5424078 Aqueous ophthalmic formulations and methods for preserving same Claim Types: Formulation; Process | DEC 13,2012 *PED | |
| Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation | JAN 10,2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation | JAN 18,2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation | JAN 28,2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation | JAN 26,2022 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jun 20,2005 PED |
ALLERGAN
AVAGE (CREAM) TAZAROTENE
Drug Classes: ACNE PRODUCTS
NDA Applicant: ALLERGAN NDA No.: 021184 Prod. No.: 003 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5089509 [Extended 845 days (2.3 years)] Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid like activity Claim Types: Compound; Composition; Method of use | JUN 13,2011 | U-481: Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid-like activity |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | SEP 30,2005 |
ALLERGAN
ELESTAT (SOLUTION/DROPS) EPINASTINE HYDROCHLORIDE
NDA Applicant: ALLERGAN NDA No.: 021565 Prod. No.: 001 RX (0.05%)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | OCT 15,2008 |
ALLERGAN
LUMIGAN (SOLUTION/DROPS) BIMATOPROST
Drug Classes: OPHTHALMICS, MISCELLANEOUS
NDA Applicant: ALLERGAN NDA No.: 021275 Prod. No.: 001 RX (0.03%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5688819 Cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl derivatives as therapeutic agents Claim Types: Method of use | SEP 21,2012 | |
| Pat. No. 6403649 Non-acidic cyclopentane heptanoic acid,2-cycloalkyl or arylalkyl derivatives as therapeutic agents Claim Types: Compound; Method of use | SEP 21,2012 | U-446: Topical treatment of ocular hypertension and glaucoma |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | MAR 16,2006 |
ALLERGAN
TAZORAC (GEL) TAZAROTENE
Drug Classes: ACNE PRODUCTS; DERMATITIS/ANTIPURETICS
NDA Applicant: ALLERGAN NDA No.: 020600 Prod. No.: 001 RX (0.05%); 002 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5089509 [Extended 845 days (2.3 years)] Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid like activity Claim Types: Compound; Composition; Method of use | JUN 13,2011 | U-193: Psoriasis |
| Pat. No. 5089509 [Extended 845 days (2.3 years)] Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid like activity Claim Types: Compound; Composition; Method of use | JUN 13,2011 | U-481: Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid-like activity |
| Pat. No. 5914334 Stable gel formulation for topical treatment of skin conditions Claim Types: Formulation; Process | JUN 07,2014 | U-517: Stable gel formulation for topical treatment of skin conditions |
| Pat. No. 6258830 Stable gel formulation for topical treatment of skin conditions Claim Types: Formulation | JUN 07,2014 | U-517: Stable gel formulation for topical treatment of skin conditions |
ALLERGAN
TAZORAC (CREAM) TAZAROTENE
Drug Classes: ACNE PRODUCTS
NDA Applicant: ALLERGAN NDA No.: 021184 Prod. No.: 001 RX (0.05%); 002 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5089509 [Extended 845 days (2.3 years)] Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid like activity Claim Types: Compound; Composition; Method of use | JUN 13,2011 | U-481: Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid-like activity |
ALLERGAN
ZYMAR (SOLUTION/DROPS) GATIFLOXACIN
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: ALLERGAN NDA No.: 021493 Prod. No.: 001 RX (0.3%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4980470 DS* DP* [Extended 721 days (2 years)] 8-alkoxyquinolonecarboxylic acid and salts thereof Claim Types: Compound | DEC 16,2009 | |
| Pat. No. 5880283 8-alkoxyquinolonecarboxylic acid hydrate with excellent stability and process for producing the same Claim Types: Compound; Process | DEC 05,2015 | |
| Pat. No. 6333045 DP* Aqueous liquid pharmaceutical composition comprised of gatifloxacin Claim Types: Formulation; Method of use Process | AUG 20,2019 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | MAR 28,2006 |
ALPHARMA US PHARMS
KADIAN (CAPSULE, EXTENDED RELEASE) MORPHINE SULFATE
Drug Classes: ANALGESICS-NARCOTIC
NDA Applicant: ALPHARMA US PHARMS NDA No.: 020616 Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5202128 Sustained release pharmaceutical composition Claim Types: Formulation; Method of use | APR 13,2010 | |
| Pat. No. 5378474 Sustained release pharmaceutical composition Claim Types: Formulation | MAR 23,2010 |
ALZA
CONCERTA (TABLET, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: ALZA NDA No.: 021121 Prod. No.: 001 RX (18MG); 002 RX (36MG); 003 RX (54MG); 004 RX (27MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6919373 Methods and devices for providing prolonged drug therapy Claim Types: Method of use | JAN 31,2018 *PED | U-666: Method of treating ADHD |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Apr 21,2008 PED | D-94: New maximum dosage of 72 mg/day in adolescents 13-17 years of age with attention defecit hyperactivity disorder (ADHD) |
| Exclusivity Code: NPP - New patient population | Apr 21,2008 PED |
ALZA
DITROPAN (TABLET) OXYBUTYNIN CHLORIDE [GENERIC AB]
Drug Classes: RELAXANTS/STIMULANTS,UTERINE; RELAXANTS/STIMULANTS, URINARY TRACT
NDA Applicant: ALZA NDA No.: 017577 Prod. No.: 001 RX (5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Oct 15,2006 PED | M-28: Information from a study in pediatric patients in association with a neurological condition |
ALZA
DITROPAN (SYRUP) OXYBUTYNIN CHLORIDE [GENERIC AA]
Drug Classes: RELAXANTS/STIMULANTS, URINARY TRACT
NDA Applicant: ALZA NDA No.: 018211 Prod. No.: 001 RX (5MG/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Oct 15,2006 PED | M-28: Information from a study in pediatric patients in association with a neurological condition |
ALZA
DITROPAN XL (TABLET, EXTENDED RELEASE) OXYBUTYNIN CHLORIDE
Drug Classes: RELAXANTS/STIMULANTS, URINARY TRACT
NDA Applicant: ALZA NDA No.: 020897 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5674895 Dosage form comprising oxybutynin Claim Types: Formulation | NOV 22,2015 *PED | |
| Pat. No. 5840754 Dosage form comprising oxybutynin Claim Types: Method of use | NOV 22,2015 *PED | |
| Pat. No. 5912268 Dosage form and method for treating incontinence Claim Types: Formulation | NOV 22,2015 *PED | |
| Pat. No. 6124355 Oxybutynin therapy Claim Types: Formulation; Method of use | NOV 22,2015 *PED | U-378: Method for treating incontinence |
| Pat. No. 6262115 Method for the management of incontinence Claim Types: Method of use | NOV 22,2015 *PED | U-393: Management of incontinence, mgt of hormone replacement therapy, treatment of involuntary incontinence, mgt overactive bladder and increasing compliance in such pt |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Oct 15,2006 PED |
ALZA
DOXIL (INJECTABLE, LIPOSOMAL) DOXORUBICIN HYDROCHLORIDE
NDA Applicant: ALZA NDA No.: 050718 Prod. No.: 001 RX (2MG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code ODE: Orphan Drug | JUN 28,2006 | Treatment of ovarian cancer. |
ALZA
DURAGESIC-100; DURAGESIC-75; DURAGESIC-50; DURAGESIC-25 (FILM, EXTENDED RELEASE) FENTANYL [GENERIC AB]
Drug Classes: ANALGESICS-NARCOTIC; ANALGESICS, GENERAL
NDA Applicant: ALZA NDA No.: 019813 Prod. No.: 001 RX (100UGM/HR); 002 RX (75UGM/HR); 003 RX (50UGM/HR); 004 RX (25UGM/HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4588580 Transdermal administration of fentanyl and device therefor Claim Types: Device; Method of use | JAN 23,2005 *PED | U-43: Management of chronic pain in patients requiring opioid analgesia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Nov 20,2006 PED |
ALZA
DURAGESIC-12 (FILM, EXTENDED RELEASE) FENTANYL
Drug Classes: ANALGESICS-NARCOTIC; ANALGESICS, GENERAL
NDA Applicant: ALZA NDA No.: 019813 Prod. No.: 005 RX (12.5UGM/HR)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Nov 20,2006 PED |
ALZA
EFIDAC 24 CHLORPHENIRAMINE MALEATE (TABLET, EXTENDED RELEASE) CHLORPHENIRAMINE MALEATE
NDA Applicant: ALZA NDA No.: 019746 Prod. No.: 002 DISC (16MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4857330 Chlorpheniramine therapy Claim Types: Device | AUG 15,2006 |
ALZA
EFIDAC 24 PSEUDOEPHEDRINE HCL (TABLET, EXTENDED RELEASE) PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: ALZA NDA No.: 020021 Prod. No.: 002 OTC (240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4801461 Pseudoephedrine dosage form Claim Types: Device | MAR 14,2006 |
ALZA
EFIDAC 24 PSEUDOEPHEDRINE HCL/BROMPHENIRAMINE MALEATE (TABLET, EXTENDED RELEASE) BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: ALZA NDA No.: 019672 Prod. No.: 001 OTC (16MG;240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4662880 Pseudoephedrine, brompheniramine therapy Claim Types: Device | MAR 14,2006 | |
| Pat. No. 4801461 Pseudoephedrine dosage form Claim Types: Device | MAR 14,2006 | |
| Pat. No. 4810502 Pseudoephedrine brompheniramine therapy Claim Types: Device | MAR 14,2006 |
ALZA
TESTODERM (FILM, EXTENDED RELEASE) TESTOSTERONE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: ALZA NDA No.: 019762 Prod. No.: 001 DISC (4MG/24HR); 002 DISC (6MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4725439 Transdermal drug delivery device Claim Types: Device; Method of use | FEB 16,2005 | |
| Pat. No. 4867982 Transdermal drug delivery device Claim Types: Device; Method of use | FEB 16,2005 | |
| Pat. No. 5840327 Transdermal drug delivery device having enhanced adhesion Claim Types: Device | AUG 15,2016 |
ALZA
TESTODERM TTS (FILM, EXTENDED RELEASE) TESTOSTERONE
NDA Applicant: ALZA NDA No.: 020791 Prod. No.: 001 DISC (5MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6348210 Methods for transdermal drug administration Claim Types: Method of administration | NOV 10,2019 | U-440: Method for transdermal administration of a drug through non-scrotal skin using a transdermal drug delivery device containing the drug and having an adhesive surface |
ALZA
VIADUR (IMPLANT) LEUPROLIDE ACETATE
NDA Applicant: ALZA NDA No.: 021088 Prod. No.: 001 RX (EQ 65MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5728396 Sustained delivery of leuprolide using an implantable system Claim Types: Device; Method of use | JAN 30,2017 | U-316: Method of treating a subject suffering from prostate cancer |
| Pat. No. 5932547 Non-aqueous polar aprotic peptide formulations Claim Types: Formulation | JUN 13,2017 | |
| Pat. No. 5985305 Sustained delivery of an active agent using an implantable system Claim Types: Device | JAN 30,2017 | |
| Pat. No. 6113938 Beneficial agent delivery system with membrane plug and method for controlling delivery of beneficial agents Claim Types: Device; Process; Method of administration | JUL 24,2018 | |
| Pat. No. 6124261 Non-aqueous polar aprotic peptide formulations Claim Types: Formulation | JUN 13,2017 | |
| Pat. No. 6132420 Osmotic delivery system and method for enhancing start-up and performance of osmotic delivery systems Claim Types: Device; Method of improving a formulation | JAN 30,2017 | |
| Pat. No. 6156331 Sustained delivery of an active agent using an implantable system Claim Types: Device; Excipient | JAN 30,2017 | |
| Pat. No. 6235712 Non-aqueous polar aprotic peptide formulations Claim Types: Method of use; Process | JUN 13,2017 | |
| Pat. No. 6375978 Rate controlling membranes for controlled drug delivery devices Claim Types: Excipient as product-by-process; Process | DEC 17,2018 | |
| Pat. No. 6395292 Sustained delivery of an active agent using an implantable system Claim Types: Device; Method of use; Method of administration; Process | JAN 30,2017 |
AM BIOSCIENCE
ABRAXANE (FOR SUSPENSION) PACLITAXEL
NDA Applicant: AM BIOSCIENCE NDA No.: 021660 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5439686 DP* Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor Claim Types: Composition; Method of use | FEB 22,2013 | |
| Pat. No. 5498421 DP* Composition useful for in vivo delivery of biologics and methods employing same Claim Types: Composition; Method of use | MAR 12,2013 | U-634: Method for delivery of a biologic (including antineoplastic agents) by administering to a patient an effective amount of a biologic as a solid or liquid with a polymeric biocompatible material |
| Pat. No. 6096331 DP* Methods and compositions useful for administration of chemotherapeutic agents Claim Types: Method of administration; Method of use | FEB 22,2013 | U-633: Method for treatment of tumors by administering paclitaxel at a dose in the range of about 30mg/meter square to about 100mg/meter square in a pharmaceutically acceptable formulation that does not contain cremophor |
| Pat. No. 6506405 DP* Methods and formulations of cremophor-free taxanes Claim Types: Composition; Method of use; Drug in a container | FEB 22,2013 | U-633: Method for treatment of tumors by administering paclitaxel at a dose in the range of about 30mg/meter square to about 100mg/meter square in a pharmaceutically acceptable formulation that does not contain cremophor |
| Pat. No. 6537579 Compositions and methods for administration of pharmacologically active compounds Claim Types: Method of use | FEB 22,2013 | U-632: Method of treatment of cancer by administering particles of paclitaxel that have a protein coating |
| Pat. No. 6749868 DP* Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof Claim Types: Composition | FEB 22,2013 | |
| Pat. No. 6753006 DP* Paclitaxel-containing formulations Claim Types: Composition; Drug in a container | FEB 22,2013 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | JAN 07,2008 |
AMGEN
SENSIPAR (TABLET) CINACALCET HYDROCHLORIDE
NDA Applicant: AMGEN NDA No.: 021688 Prod. No.: 001 RX (EQ 30MG BASE); 003 RX (EQ 90MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6011068 DS* DP* Calcium receptor-active molecules Claim Types: Compound; Composition | DEC 14,2016 | |
| Pat. No. 6031003 Calcium receptor-active molecules Claim Types: Method of use | DEC 14,2016 | U-559: Method of decreasing or reducing parathyroid hormone level; method of modulating parathyroid hormone secretion; method of treating hyperparathyroidism; method of reducing serum ionized calcium level |
| Pat. No. 6211244 DS* DP* Calcium receptor-active compounds Claim Types: Compound; Composition; Method of use | OCT 23,2015 | U-560: Method of decreasing parathyroid hormone level; method of treating hyperparathyroidism |
| Pat. No. 6313146 DS* DP* Calcium receptor-active molecules Claim Types: Compound; Composition | DEC 14,2016 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | MAR 08,2009 | |
| Exclusivity Code ODE: Orphan Drug | MAR 08,2011 | Treatment of hypercalcemia in patients with parathyroid carcinoma |
AMGEN
SENSIPAR (TABLET) CINACALCET HYDROCHLORIDE
NDA Applicant: AMGEN NDA No.: 021688 Prod. No.: 002 RX (EQ 60MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6011068 DS* DP* Calcium receptor-active molecules Claim Types: Compound; Composition | DEC 14,2016 | |
| Pat. No. 6031003 Calcium receptor-active molecules Claim Types: Method of use | DEC 14,2016 | |
| Pat. No. 6211244 DS* DP* Calcium receptor-active compounds Claim Types: Compound; Composition; Method of use | OCT 23,2015 | U-560: Method of decreasing parathyroid hormone level; method of treating hyperparathyroidism |
| Pat. No. 6313146 DS* DP* Calcium receptor-active molecules Claim Types: Compound; Composition | DEC 14,2016 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | MAR 08,2009 | |
| Exclusivity Code ODE: Orphan Drug | MAR 08,2011 | Treatment of hypercalcemia in patients with parathyroid carcinoma |
AMPHASTAR PHARM
AMPHADASE (INJECTABLE) HYALURONIDASE
NDA Applicant: AMPHASTAR PHARM NDA No.: 021665 Prod. No.: 001 RX (150 UNITS/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | OCT 26,2009 |
AMYLIN
BYETTA (INJECTABLE) EXENATIDE SYNTHETIC
NDA Applicant: AMYLIN NDA No.: 021773 Prod. No.: 001 RX (300UGM/1.2ML(250UGM/ML)); 002 RX (600UGM/2.4ML(250UGM/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5424286 Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same Claim Types: Compound; Composition; Method of use | MAY 24,2013 | U-653: Stimulating insulin release by administering exenatide |
| Pat. No. 6858576 Methods for regulating gastrointestinal motility Claim Types: Method of use | JAN 06,2017 | U-656: Reducing gastric motility or delaying gastric emptying by administering an exendin, such as exendin-4 |
| Pat. No. 6872700 Methods for glucagon suppression Claim Types: Method of use | JAN 14,2020 | U-654: Lowering plasma glucagon in a subject in need thereof, including one with type 2 diabetes, by administering an exedin or analog, such as exendin-4 |
| Pat. No. 6902744 DP* Exendin agonist formulations and methods of administration thereof Claim Types: Formulation | JAN 14,2020 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | APR 28,2010 |
AMYLIN
SYMLIN (INJECTABLE) PRAMLINTIDE ACETATE
NDA Applicant: AMYLIN NDA No.: 021332 Prod. No.: 001 RX (EQ 3MG BASE/5ML (EQ 0.6MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5175145 Treatment of diabetes mellitus with amylin agonists Claim Types: Method of use | DEC 29,2009 | U-637: Treatment of diabetes with an amylin agonist |
| Pat. No. 5686411 DS* DP* Amylin agonist peptides and uses therefor Claim Types: Compound; Method of use; Composition | NOV 11,2014 | U-638: Treatment of diabetes with an amylin agonist, including with insulin |
| Pat. No. 5814600 Method and composition for treatment of insulin requiring mammals Claim Types: Method of use; Composition | SEP 29,2015 | U-639: Treatment of a mammal having a need of or reduced ability to produce insulin with an insulin and an amylin such as pramlintide |
| Pat. No. 5998367 DS* DP* Pramlintide pro H-amylin salts and compositions Claim Types: Compound; Composition | MAR 08,2011 | |
| Pat. No. 6114304 Methods for regulating gastrointestinal motility Claim Types: Method of use | SEP 05,2017 | U-640: Use of an amylin agonist to reduce gastric motility and treat post prandial hypergylcemia |
| Pat. No. 6410511 DP* Formulations for amylin agonist peptides Claim Types: Formulation; Method of use; Drug in a container | JAN 09,2018 | |
| Pat. No. 6608029 Methods for regulating gastrointestinal motility Claim Types: Method of use | SEP 07,2013 | U-641: Use of an amylin agonist having specified binding activity to reduce gastric motility, including use through parenteral administration |
| Pat. No. 6610824 DS* Amylin agonist peptides and uses therefor Claim Types: Compound; Composition | MAR 08,2011 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | MAR 16,2010 |
ANDRX LABS LLC
ALTOPREV (TABLET, EXTENDED RELEASE) LOVASTATIN
NDA Applicant: ANDRX LABS LLC NDA No.: 021316 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5916595 HMG co-reductase inhibitor Claim Types: Formulation | DEC 12,2017 | |
| Pat. No. 6080778 Methods for decreasing beta amyloid protein Claim Types: Method of use | MAR 23,2018 | U-456: Method of decreasing the production of a-beta using a composition which decreases blood cholesterol in patients at risk of or exhibiting symptoms of Alzheimer's Disease |
| Pat. No. 6485748 DP* Once daily pharmaceutical tablet having a unitary core Claim Types: Formulation | DEC 12,2017 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | JUN 26,2005 |
ANDRX LABS LLC
FORTAMET (TABLET, EXTENDED RELEASE) METFORMIN HYDROCHLORIDE [Has competitive generic]
NDA Applicant: ANDRX LABS LLC NDA No.: 021574 Prod. No.: 001 RX (500MG); 002 RX (1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6099859 DP* Controlled release oral tablet having a unitary core Claim Types: Formulation | MAR 20,2018 | |
| Pat. No. 6495162 DP* Controlled release oral tablet having a unitary core Claim Types: Formulation | MAR 20,2018 | |
| Pat. No. 6790459 Methods for treating diabetes via administration of controlled release metformin Claim Types: Method of use | MAR 17,2021 | U-604: Method of lowering blood glucose by once daily administration |
| Pat. No. 6866866 DP* Controlled release metformin compositions Claim Types: Composition; Formulation | MAR 17,2021 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | APR 27,2007 |
ANDRX PHARMS
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE (TABLET) FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE [GENERIC AB]
NDA Applicant: ANDRX PHARMS NDA No.: 076608 Prod. No.: 001 RX (10MG;12.5MG); 002 RX (20MG;12.5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | JAN 01,2005 |
ANESTA
FENTANYL (TROCHE/LOZENGE) FENTANYL CITRATE
NDA Applicant: ANESTA NDA No.: 020195 Prod. No.: 001 DISC (EQ 0.2MG BASE); 002 DISC (EQ 0.3MG BASE); 003 DISC (EQ 0.4MG BASE); 007 DISC (EQ 0.1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4671953 Methods and compositions for noninvasive administration of sedatives, analgesics, and anesthetics Claim Types: Method of administration; Formulation | MAY 01,2005 | U-87: Method for noninvasive administration of sedatives, analgesics, and anesthetics |
ANTHRA
VALSTAR PRESERVATIVE FREE (SOLUTION) VALRUBICIN
NDA Applicant: ANTHRA NDA No.: 020892 Prod. No.: 001 RX (40MG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code ODE: Orphan Drug | SEP 25,2005 | Treatment of carcinoma in situ of the urinary bladder. |
ASTELLAS
ADENOSCAN (INJECTABLE) ADENOSINE [Has competitive generic]
Drug Classes: ANTIARRHYTHMICS
NDA Applicant: ASTELLAS NDA No.: 020059 Prod. No.: 001 RX (3MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5070877 [Extended 159 days (0.4 years)] Novel method of myocardial imaging Claim Types: Diagnostic or surgical method | MAY 18,2009 | U-116: Method of myocardial imaging |
| Pat. No. 5731296 Selective vasodilation by continuous adenosine infusion Claim Types: Method of use | MAR 24,2015 | U-221: Selective vasodilation by continuous adenosine infusion |
ASTELLAS
MYCAMINE (INJECTABLE) MICAFUNGIN SODIUM
NDA Applicant: ASTELLAS NDA No.: 021506 Prod. No.: 002 RX (50MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5376634 DS* DP* Polypeptide compound and a process for preparation thereof Claim Types: Compound; Composition | DEC 27,2011 | |
| Pat. No. 6107458 DS* DP* Cyclic hexapeptides having antibiotic activity Claim Types: Compound; Process; Composition; Method of use | SEP 29,2015 | U-650: Treatment of esophageal candidiasis and prophylaxis of candida infections in HSCT patients |
| Pat. No. 6265536 DS* DP* Cyclic hexapeptides having antibiotic activity Claim Types: Compound; Composition; Method of use | SEP 29,2015 | U-650: Treatment of esophageal candidiasis and prophylaxis of candida infections in HSCT patients |
| Pat. No. 6774104 DP* Stabilized pharmaceutical composition in lyophilized form Claim Types: ; Composition; Process; Method of use | JAN 08,2021 | U-650: Treatment of esophageal candidiasis and prophylaxis of candida infections in HSCT patients |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | MAR 16,2010 |
ASTELLAS
VESICARE (TABLET) SOLIFENACIN SUCCINATE
NDA Applicant: ASTELLAS NDA No.: 021518 Prod. No.: 001 RX (5MG); 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6017927 DS* DP* Quinuclidine derivatives and medicinal composition thereof Claim Types: Compound; Composition | DEC 27,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | NOV 19,2009 |
ASTRAZENECA
ACCOLATE (TABLET) ZAFIRLUKAST
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: ASTRAZENECA NDA No.: 020547 Prod. No.: 001 RX (20MG); 003 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4859692 [Extended 1496 days (4.1 years)] Heterocyclic amide derivatives and pharmaceutical use Claim Types: Compound; Composition; Method of use | SEP 26,2010 | |
| Pat. No. 5294636 Crystalline form of indole derivative and pharmaceutical method thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use | DEC 11,2011 | |
| Pat. No. 5319097 Pharmaceutical agents Claim Types: New polymorph, salt or hydrate; Composition; Process | DEC 11,2011 | |
| Pat. No. 5482963 Pharmaceutical agents useful as leukotriene antagonists Claim Types: Composition; Method of use | JAN 09,2013 | |
| Pat. No. 5583152 Method for treating vasospastic cardiovascular diseases heterocyclic amide derivatives Claim Types: Method of use | SEP 26,2010 | |
| Pat. No. 5612367 Method of enhancing bioavailability of pharmaceutical agents Claim Types: Process | MAR 18,2014 | U-189: Enhancement of the bioavailability of the drug substance |
| Pat. No. 6143775 Process for preparing pharmaceutical composition containing a heterocyclic amide Claim Types: New polymorph, salt or hydrate | DEC 11,2011 |
ASTRAZENECA
ARIMIDEX (TABLET) ANASTROZOLE
Drug Classes: ANTINEOPLASTICS
NDA Applicant: ASTRAZENECA NDA No.: 020541 Prod. No.: 001 RX (1MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE36617 (Substituted aralkyl) heterocyclic compounds Claim Types: Compound; Composition; Method of use | DEC 27,2009 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | SEP 05,2005 | I-363: Adjuvant treatment of post menopausal women with hormone receptor positive early breast cancer |
ASTRAZENECA
ATACAND (TABLET) CANDESARTAN CILEXETIL
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: ASTRAZENECA NDA No.: 020838 Prod. No.: 001 RX (4MG); 002 RX (8MG); 003 RX (16MG); 004 RX (32MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5196444 DS* DP* [Extended 413 days (1.1 years)] 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl] benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof Claim Types: Composition; Method of use | JUN 04,2012 | U-3: Treatment of hypertension |
| Pat. No. 5196444 DS* DP* [Extended 413 days (1.1 years)] 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl] benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof Claim Types: Composition; Method of use | JUN 04,2012 | U-660: Treatment of hypertension and treatment of heart failure |
| Pat. No. 5534534 DP* Pharmaceutical compositions for oral use and method of preparing them Claim Types: Formulation | JUL 09,2013 | |
| Pat. No. 5705517 DS* DP* Benzimidazole derivatives and use thereof Claim Types: Compound; Composition; Method of use | APR 18,2011 | U-660: Treatment of hypertension and treatment of heart failure |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | FEB 22,2008 | I-448: Treatment of heart failure (NYHA class ii-iv and ejection fraction <=40%) to reduce the risk of death from cardiovascular causes and to reduce hospitalizations for heart failure |
| Exclusivity Code: I - New Indication | MAY 18,2008 | I-455: Modified heart failure indication to include treatment of heart failure in patients with left ventricular systolic dysfunction (NYHA class II-IV; ejection fraction less than or equal to 40% |
| Exclusivity Code: I - New Indication | MAY 18,2008 | I-456: To reduce cardiovascular death and to reduce heart failure hospitalizations. includes additional information on the added effect on these outcomes when used with an ACE inhibitor |
| Exclusivity Code: M - Miscellaneous | SEP 13,2005 | M-21: Comparison data on the antihypertensive effects of ATACAND and COZAAR |
ASTRAZENECA
ATACAND HCT (TABLET) CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
NDA Applicant: ASTRAZENECA NDA No.: 021093 Prod. No.: 001 RX (16MG;12.5MG); 002 RX (32MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5196444 [Extended 413 days (1.1 years)] 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl] benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof Claim Types: Composition; Method of use | JUN 04,2012 | U-3: Treatment of hypertension |
| Pat. No. 5534534 Pharmaceutical compositions for oral use and method of preparing them Claim Types: Formulation | JUL 09,2013 | |
| Pat. No. 5703110 Benzimidazole derivatives, their production and use Claim Types: Compound; Composition; Method of use | APR 18,2011 | U-3: Treatment of hypertension |
| Pat. No. 5705517 Benzimidazole derivatives and use thereof Claim Types: Compound; Composition; Method of use | APR 18,2011 | U-3: Treatment of hypertension |
| Pat. No. 5721263 Pharmaceutical composition for angiotensin II-mediated diseases Claim Types: Composition; Method of use | FEB 24,2015 | U-3: Treatment of hypertension |
| Pat. No. 5958961 Pharmaceutical composition for angiotensin II-mediated diseases Claim Types: Composition; Method of use | JUN 06,2014 | U-3: Treatment of hypertension |
ASTRAZENECA
CASODEX (TABLET) BICALUTAMIDE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: ASTRAZENECA NDA No.: 020498 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4636505 [Extended 1723 days (4.7 years)] Amide derivatives Claim Types: Compound; Composition; Method of use | OCT 01,2008 |
ASTRAZENECA
CRESTOR (TABLET) ROSUVASTATIN CALCIUM
Drug Classes: METABOLICS/NUTRIENTS
NDA Applicant: ASTRAZENECA NDA No.: 021366 Prod. No.: 002 RX (5MG); 003 RX (10MG); 004 RX (20MG); 005 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6316460 Pharmaceutical compositions Claim Types: Formulation; Process | AUG 04,2020 | |
| Pat. No. 6589959 Crystalline bis[(e)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)- 3,5-dihydroxyhept-6-enoic acid]calcium salt Claim Types: New polymorph, salt or hydrate | DEC 23,2019 | |
| Pat. No. 6858618 Use of rosuvastatin (zd-4522) in the treatment of heterozygous familial hypercholesterolemia Claim Types: Method of use | DEC 17,2021 | U-618: Use of rosuvastatin calcium to reduce elevated total-c, LDL-c, Apob,nonHDL-c or TG levels;to increase HDL-c; and to treat patients with primary hypercholestrolemia |
| Pat. No. RE37314 Pyrimidine derivatives Claim Types: Compound; Composition | JUN 12,2012 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | AUG 12,2008 |
ASTRAZENECA
DIPRIVAN (INJECTABLE) PROPOFOL [GENERIC AB]
Drug Classes: ANESTHETICS, GENERAL
NDA Applicant: ASTRAZENECA NDA No.: 019627 Prod. No.: 002 RX (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5714520 Propofol compostion containing edetate Claim Types: Formulation | SEP 22,2015 *PED | |
| Pat. No. 5731355 Pharmaceutical compositions of propofol and edetate Claim Types: Method of use | SEP 22,2015 *PED | U-217: Method of producing anesthesia |
| Pat. No. 5731356 Pharmaceutical compositions of propofol and edetate Claim Types: Process | SEP 22,2015 *PED | U-218: Method for limiting the potential for microbial growth in the drug product |
| Pat. No. 5908869 Propofol compositions containing edetate Claim Types: Process | SEP 22,2015 *PED | U-270: Method of improving the time for administration or the time between changes of giving sets for the drug product |
ASTRAZENECA
ENTOCORT EC (CAPSULE) BUDESONIDE
Drug Classes: VASCULAR DISORDERS, CEREBRAL/PERIPHERAL
NDA Applicant: ASTRAZENECA NDA No.: 021324 Prod. No.: 001 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5643602 DP* Oral composition for the treatment of inflammatory bowel disease Claim Types: Formulation; Process | JAN 01,2015 *PED | U-655: Treatment of mild to moderate active Chrohn's disease involving the ileum and/or the ascending colon and the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or ascending colon for up to 3 months |
| Pat. No. 6423340 Method for the treatment of inflammatory bowel diseases Claim Types: Method of use | MAY 11,2011 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | APR 29,2008 | I-454: Maintenance of clinical remission of mild to moderate Chron's disease involving the ileum and/or the ascending colon for up to 3 months |
| Exclusivity Code: NP - New product | Apr 02,2005 PED |
ASTRAZENECA
FASLODEX (INJECTABLE) FULVESTRANT
Drug Classes: ESTROGENS/PROGESTINS
NDA Applicant: ASTRAZENECA NDA No.: 021344 Prod. No.: 001 RX (50MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4659516 Steroid derivatives Claim Types: Compound; Method of use | OCT 01,2005 | |
| Pat. No. 6774122 Formulation Claim Types: Method of use | JAN 09,2021 | U-596: Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | APR 25,2007 |
ASTRAZENECA
IRESSA (TABLET) GEFITINIB
NDA Applicant: ASTRAZENECA NDA No.: 021399 Prod. No.: 001 RX (250MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5457105 Quinazoline derivatives useful for treatment of neoplastic disease Claim Types: Compound; Composition; Method of use | JAN 19,2013 | |
| Pat. No. 5616582 Quinazoline derivatives as anti-proliferative agents Claim Types: Method of use | JAN 19,2013 | |
| Pat. No. 5770599 Quinazoline derivatives Claim Types: Compound; Composition; Method of use; Process | APR 26,2016 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | MAY 05,2008 |
ASTRAZENECA
LEXXEL (TABLET, EXTENDED RELEASE) ENALAPRIL MALEATE; FELODIPINE
Drug Classes: CALCIUM CHANNEL BLOCKERS; ACE INHIBITORS
NDA Applicant: ASTRAZENECA NDA No.: 020668 Prod. No.: 001 RX (5MG;5MG); 002 RX (5MG;2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4703038 Combination of dihydropyridines with angiotensin converting enzymes-inhibitors Claim Types: Composition; Method of use | OCT 07,2005 | U-3: Treatment of hypertension |
| Pat. No. 4803081 New pharmaceutical preparations with extended release Claim Types: Formulation; Process | OCT 03,2007 *PED |
ASTRAZENECA
NAROPIN (INJECTABLE) ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
Drug Classes: SURGICAL AIDS; ANESTHETICS, LOCAL; PHARMACEUTICAL AIDS; ANTISEPTICS/DISINFECTANTS; ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: ASTRAZENECA NDA No.: 020533 Prod. No.: 001 RX (2MG/ML); 003 RX (5MG/ML); 004 RX (7.5MG/ML); 005 RX (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4870086 [Extended 1400 days (3.8 years)] Optically pure compound and a process for its preparation Claim Types: Compound; Process; Method of use | SEP 24,2010 |
ASTRAZENECA
NEXIUM (CAPSULE, DELAYED REL PELLETS) ESOMEPRAZOLE MAGNESIUM
Drug Classes: GASTROINTESTINAL, MISCELLANEOUS
NDA Applicant: ASTRAZENECA NDA No.: 021153 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4738974 DS* DP* [Extension length not available] Base addition salts of omeprazole Claim Types: Compound; Composition; Method of use | OCT 19,2006 *PED | U-373: General use claim submitted for 12 NEXIUM patients stating "pertinent to the capsule formulation for NEXIUM and its indications for the treatment of GERD and eradication of H. pylori to reduce the risk of duodenal ulcer recurrence |
| Pat. No. 4786505 Pharmaceutical preparation for oral use Claim Types: Formulation; Method of use; Process | OCT 20,2007 *PED | U-373: General use claim submitted for 12 NEXIUM patients stating "pertinent to the capsule formulation for NEXIUM and its indications for the treatment of GERD and eradication of H. pylori to reduce the risk of duodenal ulcer recurrence |
| Pat. No. 4853230 Pharmaceutical formulations of acid labile substances for oral use Claim Types: Formulation; Process; Method of use | OCT 20,2007 *PED | U-373: General use claim submitted for 12 NEXIUM patients stating "pertinent to the capsule formulation for NEXIUM and its indications for the treatment of GERD and eradication of H. pylori to reduce the risk of duodenal ulcer recurrence |
| Pat. No. 5690960 Pharmaceutical formulation of omeprazole Claim Types: Formulation; Process; Method of use | MAY 25,2015 *PED | U-373: General use claim submitted for 12 NEXIUM patients stating "pertinent to the capsule formulation for NEXIUM and its indications for the treatment of GERD and eradication of H. pylori to reduce the risk of duodenal ulcer recurrence |
| Pat. No. 5714504 Compositions Claim Types: Formulation; Method of use | AUG 03,2015 *PED | U-373: General use claim submitted for 12 NEXIUM patients stating "pertinent to the capsule formulation for NEXIUM and its indications for the treatment of GERD and eradication of H. pylori to reduce the risk of duodenal ulcer recurrence |
| Pat. No. 5877192 Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole Claim Types: Method of use; Process | NOV 27,2014 *PED | U-373: General use claim submitted for 12 NEXIUM patients stating "pertinent to the capsule formulation for NEXIUM and its indications for the treatment of GERD and eradication of H. pylori to reduce the risk of duodenal ulcer recurrence |
| Pat. No. 5900424 Omeprazole magnesium salt form Claim Types: Composition; Formulation; Method of use; Process | NOV 04,2016 *PED | U-373: General use claim submitted for 12 NEXIUM patients stating "pertinent to the capsule formulation for NEXIUM and its indications for the treatment of GERD and eradication of H. pylori to reduce the risk of duodenal ulcer recurrence |
| Pat. No. 6147103 Omeprazole process and compositions thereof Claim Types: Formulation | APR 09,2019 *PED | |
| Pat. No. 6166213 Omeprazole process and compositions thereof Claim Types: Process; Product-by-process Comments: Omeprazole produced by the claimed process that has less than a specified level of residual solvent | APR 09,2019 *PED | |
| Pat. No. 6191148 Omerazole process and compositions thereof Claim Types: Formulation Comments: Omeprazole having specified purity and residual solvent levels | APR 09,2019 *PED | |
| Pat. No. 6369085 Form of S-omeprazole Claim Types: New polymorph, salt or hydrate; Method of use; Process | NOV 25,2018 *PED | |
| Pat. No. 6428810 Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process | MAY 03,2020 *PED | U-469: Treatment of gastroesophageal reflex disease (GERD) and eradication of H. pylori to reduce risk of duodenal ulcer recurrence |
| Pat. No. 6875872 DS* Compounds Claim Types: New polymorph, salt or hydrate | NOV 27,2014 *PED |
ASTRAZENECA
NEXIUM IV (INJECTABLE) ESOMEPRAZOLE SODIUM
NDA Applicant: ASTRAZENECA NDA No.: 021689 Prod. No.: 001 RX (20MG/VIAL); 002 RX (40MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5877192 Method for the treatment of gastric acid-related diseases and production of medication using (-) enantiomer of omeprazole Claim Types: Method of use; Process | NOV 27,2014 *PED | U-643: The short term treatment (up to 10 days) in pts having gastroesophageal reflux disease (GERD) as an alternative to oral therapy in pts when therapy with NEXIUM capsules is not possible or appropriate |
| Pat. No. 6143771 DP* Compounds Claim Types: Composition; Formulation; Method of use | MAY 27,2014 | U-643: The short term treatment (up to 10 days) in pts having gastroesophageal reflux disease (GERD) as an alternative to oral therapy in pts when therapy with NEXIUM capsules is not possible or appropriate |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NE - New ester or salt of an active ingredient | MAR 31,2008 |
ASTRAZENECA
NOLVADEX (TABLET) TAMOXIFEN CITRATE [GENERIC AB]
Drug Classes: ANTINEOPLASTICS
NDA Applicant: ASTRAZENECA NDA No.: 017970 Prod. No.: 001 RX (EQ 10MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Mar 01,2006 PED | M-20: Labeling revisions related to McCune Albright Syndrome |
ASTRAZENECA
PLENDIL (TABLET, EXTENDED RELEASE) FELODIPINE [GENERIC AB]
Drug Classes: CALCIUM CHANNEL BLOCKERS; ANTIHYPERTENSIVES
NDA Applicant: ASTRAZENECA NDA No.: 019834 Prod. No.: 001 RX (5MG); 002 RX (10MG); 004 RX (2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4803081 New pharmaceutical preparations with extended release Claim Types: Formulation; Process | OCT 03,2007 *PED |
ASTRAZENECA
PRILOSEC (CAPSULE, DELAYED REL PELLETS) OMEPRAZOLE [GENERIC AB]
Drug Classes: DISORDERS, ACID/PEPTIC; GASTROINTESTINAL, MISCELLANEOUS
NDA Applicant: ASTRAZENECA NDA No.: 019810 Prod. No.: 001 RX (20MG); 002 RX (40MG); 003 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4786505 Pharmaceutical preparation for oral use Claim Types: Formulation; Method of use; Process | OCT 20,2007 *PED | U-108: Short-term treatment of active duodenal ulcer, gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive symptomatic gerd, pathological hypersecretory conditions and maintenance of healing of erosive esophagitis |
| Pat. No. 4853230 Pharmaceutical formulations of acid labile substances for oral use Claim Types: Formulation; Process; Method of use | OCT 20,2007 *PED | U-108: Short-term treatment of active duodenal ulcer, gastroesophageal reflux disease (GERD), severe erosive esophagitis, poorly responsive symptomatic gerd, pathological hypersecretory conditions and maintenance of healing of erosive esophagitis |
| Pat. No. 6147103 Omeprazole process and compositions thereof Claim Types: Formulation | APR 09,2019 *PED | |
| Pat. No. 6150380 Crystalline form of omeprazole Claim Types: New polymorph, salt or hydrate; Composition; Process | MAY 10,2019 *PED | |
| Pat. No. 6166213 Omeprazole process and compositions thereof Claim Types: Process; Product-by-process Comments: Omeprazole produced by the claimed process that has less than a specified level of residual solvent | APR 09,2019 *PED | |
| Pat. No. 6191148 Omerazole process and compositions thereof Claim Types: Formulation Comments: Omeprazole having specified purity and residual solvent levels | APR 09,2019 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 12,2006 PED | M-19: Information regarding use in pediatric patients two years of age and older |
ASTRAZENECA
PRILOSEC OTC (TABLET, DELAYED RELEASE) OMEPRAZOLE MAGNESIUM
NDA Applicant: ASTRAZENECA NDA No.: 021229 Prod. No.: 001 OTC (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4738974 [Extension length not available] Base addition salts of omeprazole Claim Types: Compound; Composition; Method of use | APR 19,2005 | |
| Pat. No. 4786505 Pharmaceutical preparation for oral use Claim Types: Formulation; Method of use; Process | OCT 20,2007 *PED | |
| Pat. No. 4853230 Pharmaceutical formulations of acid labile substances for oral use Claim Types: Formulation; Process; Method of use | OCT 20,2007 *PED | |
| Pat. No. 5690960 Pharmaceutical formulation of omeprazole Claim Types: Formulation; Process; Method of use | NOV 25,2014 | |
| Pat. No. 5753265 Multiple unit pharmaceutical preparation Claim Types: Formulation; Process; Drug in a container; Method of use | JUN 07,2015 | |
| Pat. No. 5817338 Multiple unit tableted dosage form of omeprazole Claim Types: Formulation; Process; Method of use; Drug in a container | OCT 06,2015 | |
| Pat. No. 5900424 Omeprazole magnesium salt form Claim Types: Composition; Formulation; Method of use; Process | MAY 04,2016 | |
| Pat. No. 6403616 Chemical process and pharmaceutical formulation Claim Types: Product-by-process; Method of use; Process | NOV 15,2019 | |
| Pat. No. 6428810 Pharmaceutical formulation comprising omeprazole Claim Types: Formulation; Method of use; Process | NOV 03,2019 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: RTO - RX to OTC switch or OTC use | JUN 20,2006 |
ASTRAZENECA
PULMICORT (POWDER, METERED) BUDESONIDE
Drug Classes: CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: ASTRAZENECA NDA No.: 020441 Prod. No.: 002 RX (0.16MG/INH) NDA No.: 020441 Prod. No.: 003 DISC (0.32MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4668218 Indicating means for a dosage dispensing device Claim Types: Device | OCT 11,2006 *PED | |
| Pat. No. 4907583 Device in powder inhalators Claim Types: Device | SEP 13,2007 *PED |
ASTRAZENECA
PULMICORT RESPULES (SUSPENSION) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA NDA No.: 020929 Prod. No.: 001 RX (0.25MG/2ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4787536 Dosage package Claim Types: Device; Process | AUG 27,2006 *PED | |
| Pat. No. 6598603 Method for treating respiratory diseases Claim Types: Method of use; Kit | JUN 23,2019 *PED | U-529: Once daily treatment of asthma with nebulized budesonide |
| Pat. No. 6899099 Method for treating a respiratory disease Claim Types: Kit; Method of use | DEC 23,2018 | U-645: Treatment of asthma |
ASTRAZENECA
PULMICORT RESPULES (SUSPENSION) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA NDA No.: 020929 Prod. No.: 002 RX (0.5MG/2ML) NDA No.: 020929 Prod. No.: 003 DISC (1MG/2ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4787536 Dosage package Claim Types: Device; Process | AUG 27,2006 *PED | |
| Pat. No. 6598603 Method for treating respiratory diseases Claim Types: Method of use; Kit | JUN 23,2019 *PED | U-529: Once daily treatment of asthma with nebulized budesonide |
ASTRAZENECA
RHINOCORT (SPRAY, METERED) BUDESONIDE
Drug Classes: CORTICOSTEROIDS-INHALATION/NASAL; ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA NDA No.: 020746 Prod. No.: 001 RX (0.032MG/INH); 002 RX (0.064MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6291445 Low dose budesonide formulations and uses thereof Claim Types: Formulation; Drug in a container; Method of use | OCT 29,2017 *PED | |
| Pat. No. 6686346 DP* Formulation Claim Types: Formulation; Method of use; Device | APR 29,2017 | U-557: Nasal treatment of seasonal and perennial allergic rhinitis symptoms |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Apr 26,2005 PED | M-22: Change in time to onset of action |
ASTRAZENECA
SEROQUEL (TABLET) QUETIAPINE FUMARATE
Drug Classes: ANTIPSYCHOTICS/ANTIMANICS; ANTIDEPRESSANTS
NDA Applicant: ASTRAZENECA NDA No.: 020639 Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 200MG BASE); 004 RX (EQ 150MG BASE); 005 RX (EQ 300MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4879288 DS* DP* [Extended 1651 days (4.5 years)] Novel dibenzothiazepine antipsychotic Claim Types: Compound; Method of use; Composition | SEP 26,2011 | U-550: Treatment of Bipolar Mania and schizophrenia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JAN 12,2007 | I-418: Adjunctive therapy w/ mood stabilizers (lithium or divalproex) in the treatment of acute manic episodes associated with Bipolar I Disorders |
| Exclusivity Code: I - New Indication | JAN 12,2007 | I-419: Monotherapy in the treatment of acute manic episodes associated with Bipolar I Disorder |
ASTRAZENECA
TOPROL-XL (TABLET, EXTENDED RELEASE) METOPROLOL SUCCINATE
Drug Classes: BETA BLOCKERS
NDA Applicant: ASTRAZENECA NDA No.: 019962 Prod. No.: 001 RX (EQ 50MG TARTRATE); 002 RX (EQ 100MG TARTRATE); 003 RX (EQ 200MG TARTRATE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4927640 DP* Controlled release beads having glass or silicon dioxide core Claim Types: Formulation; Process | MAY 22,2007 | |
| Pat. No. 4957745 DP* Pharmaceutical preparation Claim Types: Formulation; Method of use | SEP 18,2007 | U-107: Treatment of hypertension and angina pectoris |
| Pat. No. 5001161 DP* Pharmaceutical composition comprising metroprolol succinate Claim Types: Composition | SEP 18,2007 | |
| Pat. No. 5081154 DS* Metoprolol succinate Claim Types: Compound | SEP 18,2007 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | FEB 15,2008 | D-95: Broadened initial starting dose for hypertension from 50 mg to 100 mg to 25 mg to 100 mg dose range |
ASTRAZENECA
TOPROL-XL (TABLET, EXTENDED RELEASE) METOPROLOL SUCCINATE
Drug Classes: BETA BLOCKERS
NDA Applicant: ASTRAZENECA NDA No.: 019962 Prod. No.: 004 RX (EQ 25MG TARTRATE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4927640 DP* Controlled release beads having glass or silicon dioxide core Claim Types: Formulation; Process | MAY 22,2007 | |
| Pat. No. 4957745 DP* Pharmaceutical preparation Claim Types: Formulation; Method of use | SEP 18,2007 | U-107: Treatment of hypertension and angina pectoris |
| Pat. No. 5001161 DP* Pharmaceutical composition comprising metroprolol succinate Claim Types: Composition | SEP 18,2007 | U-107: Treatment of hypertension and angina pectoris |
| Pat. No. 5081154 DS* Metoprolol succinate Claim Types: Compound | SEP 18,2007 | U-107: Treatment of hypertension and angina pectoris |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | FEB 15,2008 | D-95: Broadened initial starting dose for hypertension from 50 mg to 100 mg to 25 mg to 100 mg dose range |
ASTRAZENECA
ZESTRIL (TABLET) LISINOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: ASTRAZENECA NDA No.: 019777 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (40MG); 005 RX (2.5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Nov 29,2006 PED |
ASTRAZENECA
ZESTRIL (TABLET) LISINOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: ASTRAZENECA NDA No.: 019777 Prod. No.: 006 RX (30MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | MAY 29,2006 |
ASTRAZENECA
ZOLADEX (IMPLANT) GOSERELIN ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: ASTRAZENECA NDA No.: 019726 Prod. No.: 001 RX (EQ 3.6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4767628 Continuous release pharmaceutical compositions Claim Types: Formulation | AUG 30,2005 | |
| Pat. No. 5366734 Continuous release pharmaceutical compositions Claim Types: Method of administration | NOV 22,2011 |
ASTRAZENECA
ZOLADEX (IMPLANT) GOSERELIN ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: ASTRAZENECA NDA No.: 020578 Prod. No.: 001 RX (EQ 10.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4767628 Continuous release pharmaceutical compositions Claim Types: Formulation | AUG 30,2005 | |
| Pat. No. 5366734 Continuous release pharmaceutical compositions Claim Types: Method of administration | NOV 22,2011 |
ASTRAZENECA
ZOMIG (SPRAY) ZOLMITRIPTAN
Drug Classes: ANTIMIGRAINE/OTHER HEADACHES
NDA Applicant: ASTRAZENECA NDA No.: 021450 Prod. No.: 004 RX (5MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5466699 Indolyl compounds for treating migraine Claim Types: Compound; Composition; Method of use | MAY 14,2013 *PED | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 6750237 DP* Pharmaceutical formulations containing zolmitriptan Claim Types: Composition; Formulation | MAY 28,2021 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | Mar 26,2007 PED |
ASTRAZENECA
ZOMIG-ZMT (TABLET, ORALLY DISINTEGRATING) ZOLMITRIPTAN
Drug Classes: ANTIMIGRAINE/OTHER HEADACHES
NDA Applicant: ASTRAZENECA NDA No.: 021231 Prod. No.: 001 RX (2.5MG); 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5466699 Indolyl compounds for treating migraine Claim Types: Compound; Composition; Method of use | MAY 14,2013 *PED |
AUXILIUM PHARMS
TESTIM (GEL) TESTOSTERONE
NDA Applicant: AUXILIUM PHARMS NDA No.: 021454 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5023252 Transdermal and trans-membrane delivery of drugs Claim Types: Method of improving a treatment; Formulation | JUN 11,2008 | U-483: Method for the administration of drugs using that compound |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | OCT 31,2005 |
AVENTIS
DDAVP (SOLUTION; SPRAY, METERED) DESMOPRESSIN ACETATE [Has competitive generic]
Drug Classes: ANTIDIURETICS
NDA Applicant: AVENTIS NDA No.: 017922 Prod. No.: 001 RX (0.01%) NDA No.: 017922 Prod. No.: 002 DISC (0.01MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5500413 Process for manufacture of 1-deamino-8-D-arginine vasopressin Claim Types: Method of use; Product-by-process; Process | JUN 29,2013 | |
| Pat. No. 5674850 High purity desmopressin produced in large single batches Claim Types: Product-by-process; Process | DEC 23,2013 | |
| Pat. No. 5763407 High-purity desmopressin produced in large single batches Claim Types: Method of use; Product-by-process | JUN 29,2013 |
AVENTIS
DDAVP (INJECTABLE) DESMOPRESSIN ACETATE [GENERIC AP]
Drug Classes: ANTIDIURETICS
NDA Applicant: AVENTIS NDA No.: 018938 Prod. No.: 001 RX (0.004MG/ML); 002 RX (0.015MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5500413 Process for manufacture of 1-deamino-8-D-arginine vasopressin Claim Types: Method of use; Product-by-process; Process | JUN 29,2013 | |
| Pat. No. 5763407 High-purity desmopressin produced in large single batches Claim Types: Method of use; Product-by-process | JUN 29,2013 |
AVENTIS
DDAVP (TABLET) DESMOPRESSIN ACETATE [GENERIC AB]
Drug Classes: ANTIDIURETICS
NDA Applicant: AVENTIS NDA No.: 019955 Prod. No.: 001 RX (0.1MG); 002 RX (0.2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5047398 DDAVP antidiuretic and method therefor Claim Types: Composition; Method of use | SEP 10,2008 | |
| Pat. No. 5500413 Process for manufacture of 1-deamino-8-D-arginine vasopressin Claim Types: Method of use; Product-by-process; Process | JUN 29,2013 | |
| Pat. No. 5674850 High purity desmopressin produced in large single batches Claim Types: Product-by-process; Process | DEC 23,2013 | |
| Pat. No. 5763407 High-purity desmopressin produced in large single batches Claim Types: Method of use; Product-by-process | JUN 29,2013 |
AVENTIS
DDAVP (NEEDS NO REFRIGERATION) (SPRAY, METERED) DESMOPRESSIN ACETATE [GENERIC AB]
Drug Classes: ANTIDIURETICS
NDA Applicant: AVENTIS NDA No.: 017922 Prod. No.: 003 RX (0.01MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5482931 Stabilized pharmaceutical peptide compositions Claim Types: Formulation | JUN 29,2013 | |
| Pat. No. 5500413 Process for manufacture of 1-deamino-8-D-arginine vasopressin Claim Types: Method of use; Product-by-process; Process | JUN 29,2013 | |
| Pat. No. 5674850 High purity desmopressin produced in large single batches Claim Types: Product-by-process; Process | DEC 23,2013 | |
| Pat. No. 5763407 High-purity desmopressin produced in large single batches Claim Types: Method of use; Product-by-process | JUN 29,2013 |
AVENTIS
LOVENOX (INJECTABLE) ENOXAPARIN SODIUM
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: AVENTIS NDA No.: 020164 Prod. No.: 001 RX (30MG/0.3ML); 002 RX (40MG/0.4ML); 003 RX (60MG/0.6ML); 004 RX (80MG/0.8ML); 005 RX (100MG/ML); 007 RX (120MG/0.8ML); 008 RX (150MG/ML); 009 RX (300MG/3ML) NDA No.: 020164 Prod. No.: 006 DISC (90MG/0.6ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5389618 DS* DP* Mixtures of particular LMW heparinic polysaccharides for the prophylaxis/treatment of acute thrombotic events Claim Types: Formulation; Process | FEB 14,2012 | U-545: Method for the prevention and/or treatment of thrombotic episodes, such as myocardial infarction, in a human patient and method for the prevention of venous thrombosis in a postoperative human patient |
| Pat. No. RE38743 DS* DP* Mixtures of particular LMW heparinic polysaccharides for the prophylaxis/treatmentof acute thrombotic events Claim Types: Composition; Process; Method of use | FEB 14,2012 | U-545: Method for the prevention and/or treatment of thrombotic episodes, such as myocardial infarction, in a human patient and method for the prevention of venous thrombosis in a postoperative human patient |
AVENTIS
NASACORT (AEROSOL, METERED) TRIAMCINOLONE ACETONIDE
Drug Classes: CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: AVENTIS NDA No.: 019798 Prod. No.: 001 DISC (0.055MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4767612 Triamcinolone acetonide for the treatment of allergic rhinitis Claim Types: Method of use | JAN 23,2007 | U-85: Nasal treatment of seasonal and perennial allergic rhinitis symptoms |
AVENTIS
NASACORT AQ (SPRAY, METERED) TRIAMCINOLONE ACETONIDE
Drug Classes: CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: AVENTIS NDA No.: 020468 Prod. No.: 001 RX (0.055MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5976573 Aqueous-based pharmaceutical composition Claim Types: Formulation; Product-by-process; Process; Method of use; Method of administration | JUL 03,2016 | U-295: Treatment of seasonal and perennial allergic rhinitis symptoms |
| Pat. No. 6143329 Aqueous-based pharmaceutical composition Claim Types: Formulation; Drug in a container; Method of use; Method of administration | JUL 03,2016 |
AVENTIS
RILUTEK (TABLET) RILUZOLE [GENERIC AB]
Drug Classes: CNS, MISCELLANEOUS; NEUROLOGICS
NDA Applicant: AVENTIS NDA No.: 020599 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5527814 Use of 2-amino-6-(trifluoromethoxy)benzothiazole for obtaining a medicament for the treatment of amyotrophic lateral sclerosis Claim Types: Method of use | JUN 18,2013 |
AVENTIS PHARMS
ALLEGRA (CAPSULE) FEXOFENADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHISTAMINES
NDA Applicant: AVENTIS PHARMS NDA No.: 020625 Prod. No.: 001 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | U-192: Use in treating allergic reactions |
| Pat. No. 5738872 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation; Product-by-process | AUG 28,2015 *PED | |
| Pat. No. 5855912 Pharmaceutical compositions for piperidinalkanol compounds Claim Types: Product-by-process; Formulation | AUG 28,2015 *PED | |
| Pat. No. 5932247 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation; Product-by-process | AUG 28,2015 *PED | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6113942 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation | AUG 28,2015 *PED | |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-468: Method of using fexofenadine HCl in treating allergic rhinitis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 12,2006 PED | M-25: Additional safety & pK information in children 6 months to less than 6 years of age added to pkg insert |
AVENTIS PHARMS
ALLEGRA (TABLET) FEXOFENADINE HYDROCHLORIDE
Drug Classes: COLD REMEDIES; ANTIHISTAMINES
NDA Applicant: AVENTIS PHARMS NDA No.: 020872 Prod. No.: 001 RX (30MG); 002 RX (60MG); 004 RX (180MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | U-139: Treatment of allergic reactions |
| Pat. No. 5855912 Pharmaceutical compositions for piperidinalkanol compounds Claim Types: Product-by-process; Formulation | AUG 28,2015 *PED | |
| Pat. No. 5932247 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation; Product-by-process | AUG 28,2015 *PED | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6113942 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation | AUG 28,2015 *PED | |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-468: Method of using fexofenadine HCl in treating allergic rhinitis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 12,2006 PED | M-25: Additional safety & pK information in children 6 months to less than 6 years of age added to pkg insert |
AVENTIS PHARMS
ALLEGRA D 24 HOUR (TABLET, EXTENDED RELEASE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: AVENTIS PHARMS NDA No.: 021704 Prod. No.: 001 RX (180MG;240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 DS* DP* Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. 6004582 DP* Multi-layered osmotic device Claim Types: Device | MAY 29,2018 | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. 6613357 DP* Osmotic device containing pseudoephedrine and an H1 antagonist Claim Types: Device; Method of use | DEC 25,2020 | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
AVENTIS PHARMS
ALLEGRA-D 12 HOUR (TABLET, EXTENDED RELEASE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: COLD REMEDIES
NDA Applicant: AVENTIS PHARMS NDA No.: 020786 Prod. No.: 001 RX (60MG;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | |
| Pat. No. 5855912 Pharmaceutical compositions for piperidinalkanol compounds Claim Types: Product-by-process; Formulation | AUG 28,2015 *PED | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6039974 Pharmaceutical composition for combination of piperidinoalkanol-decongestant Claim Types: Formulation | JUL 31,2018 | |
| Pat. No. 6113942 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation | AUG 28,2015 *PED | |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-468: Method of using fexofenadine HCl in treating allergic rhinitis |
AVENTIS PHARMS
AMARYL (TABLET) GLIMEPIRIDE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: AVENTIS PHARMS NDA No.: 020496 Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (4MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4379785 [Extended 1571 days (4.3 years)] Heterocyclic substituted sulfonyl ureas, and their use Claim Types: Compound; Composition; Method of use | OCT 06,2005 *PED | U-118: Method of lowering blood sugar level |
AVENTIS PHARMS
ANZEMET (TABLET) DOLASETRON MESYLATE MONOHYDRATE
Drug Classes: ANTIEMETICS
NDA Applicant: AVENTIS PHARMS NDA No.: 020623 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4906755 [Extended 1579 days (4.3 years)] Esters of hexahydro-8-hydroxy-2,6-methano-2H-quinolizin-3-(4H)-one and related compounds Claim Types: Compound | JUL 02,2011 |
AVENTIS PHARMS
ANZEMET (INJECTABLE) DOLASETRON MESYLATE MONOHYDRATE
Drug Classes: ANTIEMETICS
NDA Applicant: AVENTIS PHARMS NDA No.: 020624 Prod. No.: 001 RX (EQ 100MG BASE/5ML); 002 RX (EQ 12.5MG BASE/0.625ML); 003 RX (EQ 500MG BASE/25ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4906755 [Extended 1579 days (4.3 years)] Esters of hexahydro-8-hydroxy-2,6-methano-2H-quinolizin-3-(4H)-one and related compounds Claim Types: Compound | JUL 02,2011 |
AVENTIS PHARMS
APIDRA (INJECTABLE) INSULIN GLULISINE RECOMBINANT
NDA Applicant: AVENTIS PHARMS NDA No.: 021629 Prod. No.: 001 DISC (100 UNITS/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action Claim Types: Compound; Process; Composition; Intermediate | JUN 18,2018 | U-471: Method of treating a patient suffering from diabetes mellitus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | APR 16,2009 |
AVENTIS PHARMS
ARAVA (TABLET) LEFLUNOMIDE
Drug Classes: ANTIARTHRITICS
NDA Applicant: AVENTIS PHARMS NDA No.: 020905 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (100MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: I - New Indication | Dec 13,2006 PED | I-395: To improve physical function |
| Exclusivity Code: M - Miscellaneous | Sep 05,2007 PED | M-32: Additional language to clinical pharmacology and clinical studies |
AVENTIS PHARMS
KETEK (TABLET) TELITHROMYCIN
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: AVENTIS PHARMS NDA No.: 021144 Prod. No.: 001 RX (400MG); 002 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5635485 DS* DP* Erythromycin compounds Claim Types: Compound; Method of use | APR 21,2015 | U-578: Treatment of community acquired pneumonia, acute exacerbation of chronic bronchitis, and acute bacterial sinusitis caused by susceptible strains of designated microorganisms in patients 18 years and older. |
| Pat. No. D459798 DP* Pill tablet Claim Types: Ornamental appearance of device or tablet | SEP 24,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | APR 01,2009 |
AVENTIS PHARMS
LANTUS (INJECTABLE) INSULIN GLARGINE RECOMBINANT
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: AVENTIS PHARMS NDA No.: 021081 Prod. No.: 001 RX (100 UNITS/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5656722 A.sup.21 -, B.sup.30 - modified insulin derivatives having an altered action profile Claim Types: Composition; Method of use | MAR 12,2015 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | MAY 01,2006 | D-80: Change of dosing schedule for LANTUS from once daily at bedtime to flexible daily dosing |
| Exclusivity Code: NCE - New chemical entity | Oct 20,2005 PED |
AVENTIS PHARMS
NICODERM CQ