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.