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