NAVELBINE (Injectable) VINORELBINE TARTRATE [GENERIC AP]
Drug Classes: ANTINEOPLASTICS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020388  Prod. No.: 001 RX (EQ 10MG BASE/ML)

Patents	Expiration	Patented Use
Pat. No. 4307100 [Extended 1053 days (2.9 years)] Nor bis-indole compounds usable as medicaments Claim Types: Compound; Composition; Method of use	Jan 8, 2003 *PED

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. 4519801 Osmotic device with wall comprising cellulose ether and permeability enhancer Claim Types: Device	Jan 12, 2003 *PED
Pat. No. 4612008 Osmotic device with dual thermodynamic activity Claim Types: Device	Mar 16, 2004 *PED
Pat. No. 4783337 Osmotic system comprising plurality of members for dispensing drug Claim Types: Device; Method of administration	Mar 16, 2004 *PED
Pat. No. 5082668 Controlled-release system with constant pushing source Claim Types: Device	Mar 16, 2004 *PED
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

SEMPREX-D (Capsule) ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: COLD REMEDIES
NDA Applicant: CELLTECH PHARMS      NDA No.: 019806  Prod. No.: 001 RX (8MG;60MG)

Patents	Expiration	Patented Use
Pat. No. 4501893 3-{6-[3-Pyrrolidino-1-(4-tolyl)prop-1-enyl]-2-pyridyl}acrylic acid and pharmaceutically acceptable salts thereof Claim Types: Compound	Feb 1, 2003
Pat. No. 4650807 [Extended 1469 days (4 years)] Antihistaminic compositions and methods containing pyridine derivatives Claim Types: Composition; Method of use	Mar 26, 2008	U-93: Use as an antihistamine/ decongestant

REV-EYES (Solution/Drops) DAPIPRAZOLE HYDROCHLORIDE
Drug Classes: PHARMACEUTICAL AIDS; OPHTHALMICS, MISCELLANEOUS; CYCLOPLEGICS/MYDRIATICS
NDA Applicant: ANGELINI      NDA No.: 019849  Prod. No.: 001 RX (0.5%)

Patents	Expiration	Patented Use
Pat. No. 4252721 [Extended 1411 days (3.9 years)] Cycloalkyltriazoles and process for obtaining same Claim Types: Compound	Feb 7, 2003

NIZORAL (Cream) KETOCONAZOLE [GENERIC AB]
Drug Classes: DERMATOLOGICS; ANTIFUNGALS
NDA Applicant: JANSSEN PHARMA      NDA No.: 019084  Prod. No.: 001 RX (2%)

Patents	Expiration	Patented Use
Pat. No. 4942162 Topical treatment of seborrheic dermatitis with ketoconazole Claim Types: Method of use	Feb 11, 2003

NIZORAL (Shampoo) KETOCONAZOLE
Drug Classes: TOPICAL ANTI-INFECTIVES; ANTIFUNGALS
NDA Applicant: MCNEIL CONS SPECLT      NDA No.: 019927  Prod. No.: 001 RX (2%)

Patents	Expiration	Patented Use
Pat. No. 4942162 Topical treatment of seborrheic dermatitis with ketoconazole Claim Types: Method of use	Feb 11, 2003

NIZORAL A-D (Shampoo) KETOCONAZOLE
NDA Applicant: MCNEIL CONS SPECLT      NDA No.: 020310  Prod. No.: 001 OTC (1%)

Patents	Expiration	Patented Use
Pat. No. 4942162 Topical treatment of seborrheic dermatitis with ketoconazole Claim Types: Method of use	Feb 11, 2003	U-245: Treatment of seborrhea dermatitis in humans
Pat. No. 5456851 Ketoconazole shampoo containing butylated hydroxytoluene or butylated hydroxyanisole Claim Types: Formulation; Process	Apr 7, 2014

NOLVADEX (Tablet) TAMOXIFEN CITRATE [GENERIC AB]
Drug Classes: ANTINEOPLASTICS; HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: ASTRAZENECA      NDA No.: 017970  Prod. No.: 001 RX (EQ 10MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4536516 Alkene derivatives Claim Types: Compound; Method of use	Feb 20, 2003 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Mar 01,2006 PED	M-20: Labeling revisions related to McCune Albright Syndrome

NOLVADEX (Tablet) TAMOXIFEN CITRATE [GENERIC AB]
Drug Classes: ANTINEOPLASTICS; HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: ASTRAZENECA      NDA No.: 017970  Prod. No.: 002 RX (EQ 20MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4536516 Alkene derivatives Claim Types: Compound; Method of use	Feb 20, 2003 *PED

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. 4673405 Osmotic system with instant drug availability Claim Types: Device	Mar 18, 2003
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

EFIDAC 24 CHLORPHENIRAMINE MALEATE (Tablet, Extended Release) CHLORPHENIRAMINE MALEATE
NDA Applicant: ALZA      NDA No.: 019746  Prod. No.: 002 OTC (16MG)

Patents	Expiration	Patented Use
Pat. No. 4576604 Osmotic system with instant drug availability Claim Types: Device	Mar 18, 2003
Pat. No. 4673405 Osmotic system with instant drug availability Claim Types: Device	Mar 18, 2003
Pat. No. 4857330 Chlorpheniramine therapy Claim Types: Device	Aug 15, 2006

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. 4576604 Osmotic system with instant drug availability Claim Types: Device	Mar 18, 2003
Pat. No. 4801461 Pseudoephedrine dosage form Claim Types: Device	Mar 14, 2006

EVISTA (Tablet) RALOXIFENE HYDROCHLORIDE
Drug Classes: ESTROGENS/PROGESTINS
NDA Applicant: LILLY      NDA No.: 020815  Prod. No.: 001 RX (60MG)

Patents	Expiration	Patented Use
Pat. No. 4418068 Antiestrogenic and antiandrugenic benzothiophenes Claim Types: Compound; Composition; Method of use	Apr 3, 2003
Pat. No. 5393763 Methods for inhibiting bone loss Claim Types: Method of use	Jul 28, 2012	U-114: Use for inhibiting bone resorption
Pat. No. 5457117 Method for inhibiting bone loss using 6-hydroxy-2-(4-hydroxyphenyl)-benzo[B][2-(piperidin-1-yl) ethoxyphenylimethanone hydrochloride Claim Types: Method of use	Jul 28, 2012	U-114: Use for inhibiting bone resorption
Pat. No. 5478847 Methods of use for inhibiting bone loss and lowering serum cholesterol Claim Types: Method of use	Mar 2, 2014	U-114: Use for inhibiting bone resorption
Pat. No. 5811120 Solid orally administerable raloxifene hydrochloride pharmaceutical formulation Claim Types: Formulation	Mar 2, 2014
Pat. No. 5972383 Solid orally administerable raloxifene hydrochloride pharmaceutical formulation Claim Types: Method of use	Mar 2, 2014	U-287: Treatment or prevention of osteoporosis
Pat. No. 6458811 Benzothiophenes formulations containing same and methods Claim Types: Formulation; Method of use	Mar 10, 2017

ACCUPRIL (Tablet) QUINAPRIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ACE INHIBITORS
NDA Applicant: PFIZER PHARMS      NDA No.: 019885  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE); 004 RX (EQ 40MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4344949 [Extended 2 years] Substituted acyl derivatives of 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acids Claim Types: Compound; Composition; Method of use	Apr 3, 2003 *PED	U-3: Treatment of hypertension
Pat. No. 5747504 Method of treating cardiac insufficiency using angiotensin-converting enzyme inhibitors Claim Types: Method of use	Oct 10, 2005 *PED	U-210: Method of treating congestive heart failure
Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process	Aug 24, 2007 *PED
Pat. No. 5684016 Method of treating cardiac insufficiency Claim Types: Method of use	May 4, 2015 *PED	U-210: Method of treating congestive heart failure

ACCURETIC (Tablet) HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Drug Classes: ANTIHYPERTENSIVES; DIURETICS; ACE INHIBITORS
NDA Applicant: PFIZER PHARMS      NDA No.: 020125  Prod. No.: 001 RX (12.5MG;EQ 10MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4344949 [Extended 2 years] Substituted acyl derivatives of 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acids Claim Types: Compound; Composition; Method of use	Apr 3, 2003 *PED	U-3: Treatment of hypertension
Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process	Aug 24, 2007 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NC - New combination	JUN 28,2003 PED

ACCURETIC (Tablet) HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Drug Classes: ANTIHYPERTENSIVES; DIURETICS; ACE INHIBITORS
NDA Applicant: PFIZER PHARMS      NDA No.: 020125  Prod. No.: 002 RX (12.5MG;EQ 20MG BASE); 003 RX (25MG;EQ 20MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4344949 [Extended 2 years] Substituted acyl derivatives of 1,2,3,4-tetrahydroisoquinoline-3-carboxylic acids Claim Types: Compound; Composition; Method of use	Apr 3, 2003 *PED	U-3: Treatment of hypertension
Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process	Aug 24, 2007 *PED

CEREBYX (Injectable) FOSPHENYTOIN SODIUM
Drug Classes: EXTRAPYRAMIDAL MOVEMENT DISORDERS; ANTICONVULSANTS
NDA Applicant: PARKE DAVIS      NDA No.: 020450  Prod. No.: 001 RX (EQ 50MG PHENYTOIN NA/ML)

Patents	Expiration	Patented Use
Pat. No. 4260769 [Extended 5 years] 5,5-Diphenylhydantoins Claim Types: Compound	Apr 7, 2003
Pat. No. 4925860 Stable pharmaceutical composition of 3-(hydroxymethyl)-5,5-diphenylhydantoin disodium phosphate ester Claim Types: Formulation; Method of use	Aug 5, 2007
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	AUG 05,2003	For the acute treatment of patients with status epilepticus of the grand mal type.

IOBENGUANE SULFATE I 131 (Injectable) IOBENGUANE SULFATE I 131
Drug Classes: DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE
NDA Applicant: CIS      NDA No.: 020084  Prod. No.: 001 RX (2.3mCi/ML)

Patents	Expiration	Patented Use
Pat. No. 4584187 Imaging agent and method of use Claim Types: Compound; Method of use	Apr 22, 2003

MYKROX (Tablet) METOLAZONE
Drug Classes: DIURETICS
NDA Applicant: CELLTECH PHARMS      NDA No.: 019532  Prod. No.: 001 RX (0.5MG)

Patents	Expiration	Patented Use
Pat. No. 4517179 Rapid dissolving, uniform drug compositions and their preparation Claim Types: Formulation; Process	Apr 29, 2003

CATAPRES-TTS-1; CATAPRES-TTS-2; CATAPRES-TTS-3 (Film, Extended Release) CLONIDINE
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 018891  Prod. No.: 001 RX (0.1MG/24HR); 002 RX (0.2MG/24HR); 003 RX (0.3MG/24HR)

Patents	Expiration	Patented Use
Pat. No. 4559222 Matrix composition for transdermal therapeutic system Claim Types: Formulation; Device	May 4, 2003

DIPROLENE (Cream, Augmented; Gel, Augmented) BETAMETHASONE DIPROPIONATE [Has competitive generic]
Drug Classes: ADRENAL CORTICOSTEROIDS; TOPICAL STEROIDS
NDA Applicant: SCHERING      NDA No.: 019408  Prod. No.: 002 RX (EQ 0.05% BASE) NDA No.: 019408  Prod. No.: 001 DISC (EQ 0.05% BASE)

Patents	Expiration	Patented Use
Pat. No. 4489070 Betamethasone dipropionate cream Claim Types: Formulation	May 13, 2003

TICLID (Tablet) TICLOPIDINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: ROCHE PALO      NDA No.: 019979  Prod. No.: 002 RX (250MG) NDA No.: 019979  Prod. No.: 001 DISC (125MG)

Patents	Expiration	Patented Use
Pat. No. 4591592 Acid stabilized compositions of thieno-pyridine derived compounds Claim Types: Formulation	May 27, 2003

MONOPRIL (Tablet) FOSINOPRIL SODIUM [GENERIC AB]
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 019915  Prod. No.: 002 RX (10MG); 003 RX (20MG); 004 RX (40MG)

Patents	Expiration	Patented Use
Pat. No. 4337201 [Extended 2 years] Phosphinylalkanoyl substituted prolines Claim Types: Compound	Jun 4, 2003 *PED
Pat. No. 5006344 Fosinopril tablet formulations Claim Types: Formulation	Jan 10, 2010 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Nov 27,2006 PED

MONOPRIL-HCT (Tablet) FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Drug Classes: DIURETICS; ACE INHIBITORS
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 020286  Prod. No.: 001 RX (20MG;12.5MG); 002 RX (10MG;12.5MG)

Patents	Expiration	Patented Use
Pat. No. 4337201 [Extended 2 years] Phosphinylalkanoyl substituted prolines Claim Types: Compound	Jun 4, 2003 *PED
Pat. No. 5006344 Fosinopril tablet formulations Claim Types: Formulation	Jan 10, 2010 *PED

DECABID (Tablet, Extended Release) INDECAINIDE HYDROCHLORIDE
NDA Applicant: LILLY      NDA No.: 019693  Prod. No.: 001 DISC (EQ 50MG BASE); 002 DISC (EQ 75MG BASE); 003 DISC (EQ 100MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4452745 [Extended 2 years] 9-Aminoalkylfluorenes Claim Types: Compound	Jun 5, 2003

PROVENTIL (Syrup) ALBUTEROL SULFATE [Has competitive generic]
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: SCHERING      NDA No.: 018062  Prod. No.: 001 DISC (EQ 2MG BASE/5ML)

Patents	Expiration	Patented Use
Pat. No. 4499108 Stable pleasant-tasting albuterol sulfate pharmaceutical formulations Claim Types: Formulation	Jun 8, 2003

VENTOLIN (Syrup) ALBUTEROL SULFATE [Has competitive generic]
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 019621  Prod. No.: 001 DISC (EQ 2MG BASE/5ML)

Patents	Expiration	Patented Use
Pat. No. 4594359 Pharmaceutical compositions Claim Types: Formulation	Jun 10, 2003

CYTOVENE IV (Injectable) GANCICLOVIR SODIUM [GENERIC AP]
Drug Classes: ANTIVIRALS
NDA Applicant: ROCHE PALO      NDA No.: 019661  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4355032 [Extended 763 days* (2.1 years)] 9-(1,3-Dihydroxy-2-propoxymethyl)guanine as antiviral agent Claim Types: Compound; Composition; Method of use	Jun 23, 2003	U-64: Treatment of viral infections

ZINECARD (Injectable) DEXRAZOXANE HYDROCHLORIDE
Drug Classes: PHARMACEUTICAL AIDS; ANTIDOTES, SPECIFIC
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 020212  Prod. No.: 001 RX (EQ 250MG BASE/VIAL); 002 RX (EQ 500MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4275063 [Extended 5 years] Pharmaceutical compositions Claim Types: Formulation; Method of use	Jun 23, 2003
Pat. No. 4963551 Stable lyophilized form of (S)-(+)-bis-4,4'-(1-methyl-1,2-ethanediyl)2,6-piperazinedione and solutions thereof Claim Types: Formulation	Dec 21, 2007
Pat. No. 5242901 Reduction of anthracycline induced cardiotoxicity Claim Types: Method of use	Sep 7, 2010	U-339: Prevention of cardio-toxicity caused by the administration of doxorubicin

CYTOVENE (Capsule) GANCICLOVIR [GENERIC AB]
Drug Classes: ANTIVIRALS
NDA Applicant: ROCHE PALO      NDA No.: 020460  Prod. No.: 001 RX (250MG); 002 RX (500MG)

Patents	Expiration	Patented Use
Pat. No. 4355032 [Extended 763 days* (2.1 years)] 9-(1,3-Dihydroxy-2-propoxymethyl)guanine as antiviral agent Claim Types: Compound; Composition; Method of use	Jun 23, 2003	U-64: Treatment of viral infections
Pat. No. 4642346 Anhydrous crystalline 9-(1,3-dihydroxy-2-propoxymethyl)guanine Claim Types: New polymorph, salt or hydrate	Jun 24, 2005

PLAVIX (Tablet) CLOPIDOGREL BISULFATE
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: SANOFI SYNTHELABO      NDA No.: 020839  Prod. No.: 001 RX (EQ 75MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4529596 Thieno [3,2-c] pyridine derivatives and their therapeutic application Claim Types: Compound; Formulation; Method of use	Jul 5, 2003
Pat. No. 4847265 [Extended 1374 days (3.8 years)] Dextro-rotatory enantiomer of methyl alpha-5 (4,5,6,7-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-acetate and the pharmaceutical compositions containing it Claim Types: Compound; Composition	Nov 17, 2011
Pat. No. 5576328 Method for the secondary prevention of ischemic events Claim Types: Method of use	Jan 31, 2014	U-432: Reduction of atherosclerotic events (myocardial infarction, stroke, and vascular death) in patients with atherosclerosis documented by recent stroke, recent myocardial infarction, or established peripheral arterial disease
Pat. No. 6429210 Polymorphic clopidogrel hydrogenesulphate form Claim Types: New polymorph, salt or hydrate	Jun 10, 2019
Pat. No. 6504030 Polymorphic form of clopidogrel hydrogen sulphate Claim Types: Product-by-process; Process	Jun 10, 2019
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	FEB 27,2005	I-349: Acute coronary syndrome

RENOVA (Cream, Augmented) TRETINOIN
Drug Classes: DERMATOLOGICS
NDA Applicant: JOHNSON AND JOHNSON      NDA No.: 019963  Prod. No.: 001 RX (0.05%)

Patents	Expiration	Patented Use
Pat. No. 4603146 Methods for retarding the effects of aging of the skin Claim Types: Method of use	Jul 29, 2003	U-131: Photodamaged skin
Pat. No. RE36068 Methods for treatment of sundamaged human skin with retinoids Claim Types: Method of use	Jul 29, 2003	U-131: Photodamaged skin

RENOVA (Cream) TRETINOIN
Drug Classes: DERMATOLOGICS
NDA Applicant: JOHNSON AND JOHNSON      NDA No.: 021108  Prod. No.: 001 RX (0.02%)

Patents	Expiration	Patented Use
Pat. No. 4603146 Methods for retarding the effects of aging of the skin Claim Types: Method of use	Jul 29, 2003	U-131: Photodamaged skin
Pat. No. RE36068 Methods for treatment of sundamaged human skin with retinoids Claim Types: Method of use	Jul 29, 2003	U-131: Photodamaged skin
Pat. No. 6531141 Oil-in-water emulsion containing tretinoin Claim Types: Formulation; Method of use	Mar 7, 2020
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	AUG 31,2003

DALGAN (Injectable) DEZOCINE
NDA Applicant: ASTRAZENECA      NDA No.: 019082  Prod. No.: 001 DISC (5MG/ML); 002 DISC (10MG/ML); 003 DISC (15MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4605671 Parenteral formulation Claim Types: Formulation	Aug 12, 2003

ARIXTRA (Injectable) FONDAPARINUX SODIUM
NDA Applicant: FONDA BV      NDA No.: 021345  Prod. No.: 001 RX (2.5MG/0.5ML)

Patents	Expiration	Patented Use
Pat. No. 4818816 Process for the organic synthesis of oligosaccharides and derivatives thereof Claim Types: Process; Compound; Composition	Aug 19, 2003
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	JUN 17,2006	I-397: Extended prophylaxis in patients undergoing hip fracture surgery
Exclusivity Code: NCE - New chemical entity	DEC 07,2006

EXOSURF NEONATAL (For Suspension) CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020044  Prod. No.: 001 RX (12MG/VIAL;108MG/VIAL;8MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4312860 [Extended 1030 days (2.8 years)] Lung surfactant compositions Claim Types: Formulation; Method of use	Aug 20, 2003
Pat. No. 4826821 Lung surfactant compositions Claim Types: Formulation	May 2, 2006
Pat. No. 5110806 Lung surfactant compositions Claim Types: Formulation	May 2, 2006

DYNACIRC (Capsule) ISRADIPINE
Drug Classes: CALCIUM CHANNEL BLOCKERS
NDA Applicant: RELIANT PHARMS      NDA No.: 019546  Prod. No.: 001 RX (2.5MG); 002 RX (5MG)

Patents	Expiration	Patented Use
Pat. No. 4466972 [Extended 2 years] Benzoxadiazoles and benzothiadiazoles, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Method of use	Aug 21, 2003	U-3: Treatment of hypertension

DYNACIRC CR (Tablet, Extended Release) ISRADIPINE
Drug Classes: CALCIUM CHANNEL BLOCKERS
NDA Applicant: RELIANT PHARMS      NDA No.: 020336  Prod. No.: 001 RX (5MG); 002 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 4466972 [Extended 2 years] Benzoxadiazoles and benzothiadiazoles, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Method of use	Aug 21, 2003	U-3: Treatment of hypertension
Pat. No. 4783337 Osmotic system comprising plurality of members for dispensing drug Claim Types: Device; Method of administration	Sep 16, 2003	U-3: Treatment of hypertension
Pat. No. 4946687 Dosage form for treating cardiovascular diseases Claim Types: Device	Aug 7, 2007
Pat. No. 4950486 Dosage form for treating cardiovascular diseases Claim Types: Formulation	Aug 21, 2007
Pat. No. 4816263 Dosage form for treating cardiovascular diseases comprising isradipine Claim Types: Method of use	Oct 2, 2007	U-3: Treatment of hypertension
Pat. No. 5030456 Dosage form for treating cardiovascular diseases Claim Types: Formulation	Jul 9, 2008

FLUDARA (Injectable) FLUDARABINE PHOSPHATE [GENERIC AP]
Drug Classes: ANTINEOPLASTICS
NDA Applicant: BERLEX      NDA No.: 020038  Prod. No.: 001 RX (50MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4357324 [Extended 2 years] Prodrug derivatives of 9.beta.-D-arabinofuranosyl-2-fluoroadenine Claim Types: Compound; Method of use	Aug 24, 2003 *PED

FLOXIN (Tablet) OFLOXACIN [GENERIC AB]
Drug Classes: QUINOLONES/DERIVATIVES; ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: ORTHO MCNEIL PHARM      NDA No.: 019735  Prod. No.: 001 RX (200MG); 002 RX (300MG); 003 RX (400MG)

Patents	Expiration	Patented Use
Pat. No. 4382892 [Extended 2 years] Benzoxazine derivatives Claim Types: Compound	Sep 2, 2003

QUIXIN (Solution/Drops) LEVOFLOXACIN
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: SANTEN      NDA No.: 021199  Prod. No.: 001 RX (0.5%)

Patents	Expiration	Patented Use
Pat. No. 4382892 [Extended 2 years] Benzoxazine derivatives Claim Types: Compound	Sep 2, 2003
Pat. No. 4551456 Ophthalmic use of norfloxacin and related antibiotics Claim Types: Method of use	Nov 14, 2003
Pat. No. 5053407 [Extended 810 days (2.2 years)] Optically active pyridobenzoxazine derivatives and anti-microbial use Claim Types: Compound; Method of use	Dec 20, 2010
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NDF - New dosage form	AUG 18,2003

RENORMAX (Tablet) SPIRAPRIL HYDROCHLORIDE
NDA Applicant: SCHERING      NDA No.: 020240  Prod. No.: 001 DISC (3MG); 002 DISC (6MG); 003 DISC (12MG); 004 DISC (24MG)

Patents	Expiration	Patented Use
Pat. No. 4470972 [Extended 2 years] 7-Carboxyalkylaminoacyl-1,4-dithia-7-azaspiro[4.4]-nonane-8-carboxylic acids Claim Types: Compound; Composition; Method of use	Sep 11, 2003	U-3: Treatment of hypertension

PROCARDIA XL (Tablet, Extended Release) NIFEDIPINE [GENERIC AB2]
Drug Classes: ANTIANGINALS; ANTIHYPERTENSIVES
NDA Applicant: PFIZER      NDA No.: 019684  Prod. No.: 001 RX (30MG); 002 RX (60MG); 003 RX (90MG)

Patents	Expiration	Patented Use
Pat. No. 4612008 Osmotic device with dual thermodynamic activity Claim Types: Device	Sep 16, 2003
Pat. No. 4765989 Osmotic device for administering certain drugs Claim Types: Device; Method of administration; Method of use	Sep 16, 2003
Pat. No. 4783337 Osmotic system comprising plurality of members for dispensing drug Claim Types: Device; Method of administration	Sep 16, 2003
Pat. No. 5264446 Solid medicament formulations containing nifedipine, and processes for their preparation Claim Types: Formulation; Method of use	Nov 23, 2010

MINIPRESS XL (Tablet, Extended Release) PRAZOSIN HYDROCHLORIDE
NDA Applicant: PFIZER      NDA No.: 019775  Prod. No.: 001 RX (2.5MG); 002 RX (5MG)

Patents	Expiration	Patented Use
Pat. No. 4612008 Osmotic device with dual thermodynamic activity Claim Types: Device	Sep 16, 2003
Pat. No. 4765989 Osmotic device for administering certain drugs Claim Types: Device; Method of administration; Method of use	Sep 16, 2003
Pat. No. 4783337 Osmotic system comprising plurality of members for dispensing drug Claim Types: Device; Method of administration	Sep 16, 2003
Pat. No. 5082668 Controlled-release system with constant pushing source Claim Types: Device	Sep 16, 2003

GLUCOTROL XL (Tablet, Extended Release) GLIPIZIDE [GENERIC AB]
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: PFIZER      NDA No.: 020329  Prod. No.: 001 RX (5MG); 002 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 4612008 Osmotic device with dual thermodynamic activity Claim Types: Device	Sep 16, 2003
Pat. No. 5082668 Controlled-release system with constant pushing source Claim Types: Device	Sep 16, 2003
Pat. No. 5545413 Dosage form for administering oral hypoglycemic glipizide Claim Types: Method of use; Formulation	Jul 21, 2008	U-111: Diabetes
Pat. No. 5024843 Oral hypoglycemic glipizide granulation Claim Types: Formulation	Sep 5, 2009
Pat. No. 5091190 Delivery system for administration blood-glucose lowering drug Claim Types: Method of use; Device	Sep 5, 2009	U-111: Diabetes
Pat. No. 5591454 Method for lowering blood glucose Claim Types: Method of use	Jan 7, 2014	U-150: Method of use for controlling hyperglycemia by administration of this sustained release dosage form of glipizide

GLUCOTROL XL (Tablet, Extended Release) GLIPIZIDE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: PFIZER      NDA No.: 020329  Prod. No.: 003 RX (2.5MG)

Patents	Expiration	Patented Use
Pat. No. 4612008 Osmotic device with dual thermodynamic activity Claim Types: Device	Sep 16, 2003
Pat. No. 5082668 Controlled-release system with constant pushing source Claim Types: Device	Sep 16, 2003
Pat. No. 5545413 Dosage form for administering oral hypoglycemic glipizide Claim Types: Method of use; Formulation	Jul 21, 2008	U-111: Diabetes
Pat. No. 5024843 Oral hypoglycemic glipizide granulation Claim Types: Formulation	Sep 5, 2009
Pat. No. 5091190 Delivery system for administration blood-glucose lowering drug Claim Types: Method of use; Device	Sep 5, 2009	U-111: Diabetes
Pat. No. 5591454 Method for lowering blood glucose Claim Types: Method of use	Jan 7, 2014	U-111: Diabetes

COVERA-HS (Tablet, Extended Release) VERAPAMIL HYDROCHLORIDE [Has competitive generic]
Drug Classes: CALCIUM CHANNEL BLOCKERS
NDA Applicant: SEARLE, GD LLC      NDA No.: 020552  Prod. No.: 001 RX (180MG); 002 RX (240MG)

Patents	Expiration	Patented Use
Pat. No. 4612008 Osmotic device with dual thermodynamic activity Claim Types: Device	Sep 16, 2003
Pat. No. 4783337 Osmotic system comprising plurality of members for dispensing drug Claim Types: Device; Method of administration	Sep 16, 2003
Pat. No. 5141752 Delayed drug delivery device Claim Types: Device	Jun 27, 2006
Pat. No. 5190765 Therapy delayed Claim Types: Formulation	Aug 14, 2007
Pat. No. 6146662 System for delaying drug delivery up to seven hours Claim Types: Formulation; Method of administration	Aug 14, 2007	U-366: Method for the treatment of cardiovascular disease through the administration of a calcium blocking vasodilator in a delayed release formulation
Pat. No. 4946687 Dosage form for treating cardiovascular diseases Claim Types: Device	Oct 2, 2007
Pat. No. 5200196 Improvement in pulsed drug therapy Claim Types: Formulation	Jan 22, 2008
Pat. No. 5030456 Dosage form for treating cardiovascular diseases Claim Types: Formulation	Nov 7, 2008
Pat. No. 5082668 Controlled-release system with constant pushing source Claim Types: Device	Jan 21, 2009
Pat. No. 5785994 Method for administering drug to gastrointestinal tract Claim Types: Method of administration	Oct 22, 2009	U-315: Method for administering drug to gastrointestinal tract
Pat. No. 5232705 Dosage form for time-varying patterns of drug delivery Claim Types: Formulation	Aug 31, 2010
Pat. No. 5160744 Verapmil therapy Claim Types: Formulation; Method of administration	Jun 27, 2011
Pat. No. 5252338 Therapy delayed Claim Types: Method of administration	Jun 27, 2011
Pat. No. 6096339 Dosage form, process of making and using same Claim Types: Process; Formulation; Method of use	Apr 4, 2017	U-365: Method for the treatment of cardiovascular disease through the administration of a calcium blocking vasodilator in our extended, controlled release formulation

SERZONE (Tablet) NEFAZODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIDEPRESSANTS
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 020152  Prod. No.: 001 RX (50MG); 002 RX (100MG); 003 RX (150MG); 004 RX (200MG); 005 RX (250MG) NDA No.: 020152  Prod. No.: 006 DISC (300MG)

Patents	Expiration	Patented Use
Pat. No. 4338317 [Extended 2 years] Phenoxyethyl-1,2,4,-triazol-3-one antidepressants Claim Types: Compound; Composition; Method of use	Sep 16, 2003 *PED

ORTHO-NOVUM 7/7/7-21; ORTHO-NOVUM 7/7/7-28 (Tablet) ETHINYL ESTRADIOL; NORETHINDRONE [Has competitive generic]
Drug Classes: ESTROGENS/PROGESTINS; CONTRACEPTIVES
NDA Applicant: ORTHO MCNEIL PHARM      NDA No.: 018985  Prod. No.: 002 RX (0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.75MG) NDA No.: 018985  Prod. No.: 001 DISC (0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.75MG)

Patents	Expiration	Patented Use
Pat. No. 4530839 Triphasic oral contraceptive Claim Types: Method of use	Sep 26, 2003
Pat. No. 4544554 Triphasic oral contraceptive Claim Types: Method of use	Sep 26, 2003
Pat. No. 4616006 Triphasic oral contraceptive Claim Types: Kit	Sep 26, 2003
Pat. No. 4628051 Triphasic oral contraceptive Claim Types: Method of use; Kit	Sep 26, 2003

ORTHO TRI-CYCLEN (Tablet) ETHINYL ESTRADIOL; NORGESTIMATE
Drug Classes: ESTROGENS/PROGESTINS; CONTRACEPTIVES
NDA Applicant: JOHNSON RW      NDA No.: 019697  Prod. No.: 002 DISC (0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG)

Patents	Expiration	Patented Use
Pat. No. 4530839 Triphasic oral contraceptive Claim Types: Method of use	Sep 26, 2003	U-112: Contraception
Pat. No. 4544554 Triphasic oral contraceptive Claim Types: Method of use	Sep 26, 2003	U-66: Triphasic regimen
Pat. No. 4616006 Triphasic oral contraceptive Claim Types: Kit	Sep 26, 2003	U-66: Triphasic regimen
Pat. No. 4628051 Triphasic oral contraceptive Claim Types: Method of use; Kit	Sep 26, 2003	U-66: Triphasic regimen

CYCLESSA (Tablet) DESOGESTREL; ETHINYL ESTRADIOL
NDA Applicant: ORGANON USA INC      NDA No.: 021090  Prod. No.: 001 RX (0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG)

Patents	Expiration	Patented Use
Pat. No. 4544554 Triphasic oral contraceptive Claim Types: Method of use	Sep 26, 2003
Pat. No. 4628051 Triphasic oral contraceptive Claim Types: Method of use; Kit	Sep 26, 2003
Pat. No. 4616006 Triphasic oral contraceptive Claim Types: Kit	Oct 7, 2003
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	DEC 20,2003

CERETEC (Injectable) TECHNETIUM TC-99M EXAMETAZIME KIT
Drug Classes: DIAGNOSTICS - RADIOPHARMACEUTICALS; DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE; ANTIDOTES, SPECIFIC; PHARMACEUTICAL AIDS
NDA Applicant: AMERSHAM HLTH      NDA No.: 019829  Prod. No.: 001 RX (N/A)

Patents	Expiration	Patented Use
Pat. No. 4615876 Macrocyclic complexes of technetium-99m for use as diagnostic radionuclides Claim Types: Composition	Oct 7, 2003
Pat. No. 4789736 Complexes of technetium-99m with propylene amine oximes Claim Types: Formulation; Excipient	Dec 6, 2005

CRINONE (Gel) PROGESTERONE
Drug Classes: ESTROGENS/PROGESTINS
NDA Applicant: COLUMBIA RES LABS      NDA No.: 020701  Prod. No.: 001 RX (4%); 002 RX (8%)

Patents	Expiration	Patented Use
Pat. No. 4615697 Bioadhesive compositions and methods of treatment therewith Claim Types: Formulation; Method of use; Device	Oct 7, 2003	U-208: Vaginal administration using specified formulation
Pat. No. 5543150 Method of progesterone delivery and affect thereof Claim Types: Method of administration; Method of use	Sep 15, 2013	U-209: Vaginal administration of progesterone using specified formulation

STRIANT (Tablet, Extended Release) TESTOSTERONE
NDA Applicant: COLUMBIA LABS      NDA No.: 021543  Prod. No.: 001 RX (30MG)

Patents	Expiration	Patented Use
Pat. No. 4615697 Bioadhesive compositions and methods of treatment therewith Claim Types: Formulation; Method of use; Device	Oct 7, 2003
Pat. No. 6248358 Bioadhesive progressive hydration tablets and methods of making and using the same Claim Types: Formulation; Method of administration; Method of use; Process	Aug 23, 2019	U-527: Method of delivering an active ingredient using a progressive hydration bioadhesive
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	JUN 19,2006

ONCOVIN (Injectable) VINCRISTINE SULFATE [GENERIC AP]
NDA Applicant: LILLY      NDA No.: 014103  Prod. No.: 003 RX (1MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4619935 Stable oncolytic formulations Claim Types: Formulation	Oct 28, 2003

SERAX (Capsule) OXAZEPAM [GENERIC AB]
Drug Classes: ANTIANXIETY
NDA Applicant: ALPHARMA      NDA No.: 015539  Prod. No.: 002 RX (10MG); 004 RX (15MG); 006 RX (30MG)

Patents	Expiration	Patented Use
Pat. No. 4620974 Pharmaceutical composition containing a liquid lubricant Claim Types: Device	Nov 4, 2003

CHIBROXIN (Solution/Drops) NORFLOXACIN
Drug Classes: OCULAR ANTI-INFECTIVE/ANTI-INFLAMMATORY
NDA Applicant: MERCK      NDA No.: 019757  Prod. No.: 001 DISC (0.3%)

Patents	Expiration	Patented Use
Pat. No. 4551456 Ophthalmic use of norfloxacin and related antibiotics Claim Types: Method of use	Nov 14, 2003	U-57: Ophthalmic use of norfloxacin

BREVIBLOC (Injectable) ESMOLOL HYDROCHLORIDE
Drug Classes: BETA BLOCKERS; ANTIARRHYTHMICS
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.: 019386  Prod. No.: 002 RX (250MG/ML) NDA No.: 019386  Prod. No.: 003 DISC (100MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4593119 Method for treatment or prophylaxis of cardiac disorders Claim Types: Compound	Dec 3, 2003 *PED
Pat. No. 5017609 Pharmaceutical composition and method of treatment or prophylaxis of cardiac disorders Claim Types: Formulation; Process	Nov 21, 2008 *PED

BREVIBLOC IN PLASTIC CONTAINER; BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER (Injectable) ESMOLOL HYDROCHLORIDE
Drug Classes: BETA BLOCKERS; ANTIARRHYTHMICS
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.: 019386  Prod. No.: 004 RX (1GM/100ML); 005 RX (2GM/100ML); 006 RX (10MG/ML); 007 RX (20MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4593119 Method for treatment or prophylaxis of cardiac disorders Claim Types: Compound	Dec 3, 2003 *PED
Pat. No. 6310094 Ready-to-use esmolol solution Claim Types: Formulation; Process	Jul 12, 2021 *PED
Pat. No. 6528540 Esmolol formulation Claim Types: Formulation; Process	Jul 12, 2021 *PED

DIPROLENE AF (Cream, Augmented) BETAMETHASONE DIPROPIONATE [GENERIC AB]
Drug Classes: DERMATOLOGICS; TOPICAL STEROIDS
NDA Applicant: SCHERING      NDA No.: 019555  Prod. No.: 001 RX (EQ 0.05% BASE)

Patents	Expiration	Patented Use
Pat. No. 4489071 Betamethasone dipropionate cream Claim Types: Formulation	Dec 9, 2003

CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Injectable) CIPROFLOXACIN
NDA Applicant: BAYER PHARMS      NDA No.: 019858  Prod. No.: 001 DISC (200MG/100ML)

Patents	Expiration	Patented Use
Pat. No. 4670444 [Extended 3 years] 7-amino-1-cyclopropyl-4-oxo-1, 4-dihydro-quinoline-and naphthyridine-3-carboxylic acids and antibacterial agents containing these compounds Claim Types: Compound; Composition; Method of use Comments: Terminal Disclaimer that is not noted on the face of the patent resulted in the expiration date of Dec. 9, 2003 (see Bayer v. Carlsbad Technology (Fed. Cir., Aug. 14, 2002)). According to the PTO listing of extended patents, the 3-year extension of this patent applies to BAYTRIL (an animal antibiotic) rather than CIPRO.	Dec 9, 2003
Pat. No. 4705789 Solutions of lactic acid salts of piperazinylquinolone- and piperazinyl-azaquinolone-carboxylic acids Claim Types: Formulation	Nov 10, 2004
Pat. No. 4808583 Solutions of lactic acid salts of piperazinylquinolone- and piperazinyl-azaquinolone-carboxylic acids Claim Types: Formulation	Feb 28, 2006
Pat. No. 4957922 Infusion solutions of 1-cyclopropyl-6-fluoro-1,4-di-hydro-4-oxo- 7-(1-piperazinyl)-quinoline-3-carboxylic acid Claim Types: Formulation	Sep 18, 2007