Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 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 04,2015 *PED | U-210: Method of treating congestive heart failure |
ACE INHIBITORS
ACCURETIC (TABLET) HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; DIURETICS; ACE INHIBITORS
NDA Applicant: PFIZER PHARMS NDA No.: 020125 Prod. No.: 001 RX (12.5MG;EQ 10MG BASE); 002 RX (12.5MG;EQ 20MG BASE); 003 RX (25MG;EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process | AUG 24,2007 *PED |
ACE INHIBITORS
ACEON (TABLET) PERINDOPRIL ERBUMINE
Drug Classes: ACE INHIBITORS
NDA Applicant: SOLVAY PHARMS NDA No.: 020184 Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (8MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4508729 [Extended 1601 days (4.4 years)] Substituted iminodiacids, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Method of use | AUG 21,2006 | |
| Pat. No. 5162362 DS* DP* Octahydroindole-2-carboxylic acids Claim Types: Compound; Composition; Method of use | NOV 10,2009 | U-531: Treatment of patients with essential hypertension. May be used alone or given with other classes of antihypertensives, especially thiazide derivatives |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | AUG 23,2008 | I-468: Use in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infection |
ACE INHIBITORS
ALTACE (CAPSULE) RAMIPRIL [GENERIC AB]
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: KING PHARMS NDA No.: 019901 Prod. No.: 001 RX (1.25MG); 002 RX (2.5MG); 003 RX (5MG); 004 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5061722 Cis, endo-2-azabicyclo-[3.3.0]-octane-3-carboxylic acids, a process for their preparation, agents containing these compounds and their use Claim Types: Compound; Composition; Method of use | OCT 19,2008 | |
| Pat. No. 5403856 Method of treating cardiac insufficiency using angiotensin-converting enzyme inhibitors Claim Types: Method of use | APR 04,2012 | U-71: Method of treatment of heart failure |
ACE INHIBITORS
CAPOTEN (TABLET) CAPTOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: PAR PHARM NDA No.: 018343 Prod. No.: 001 RX (50MG); 002 RX (25MG); 003 RX (100MG); 005 RX (12.5MG) NDA No.: 018343 Prod. No.: 004 DISC (150MG); 006 DISC (37.5MG); 007 DISC (75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5238924 Treatment of renal diseases with ace inhibitors Claim Types: Method of use | AUG 24,2010 | U-92: Treatment of diabetic nephropathy in patients with Type I insulin dependent diabetes mellitus and retinopathy |
ACE INHIBITORS
COZAAR (TABLET) LOSARTAN POTASSIUM
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: MERCK NDA No.: 020386 Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5138069 Angiotensin II receptor blocking imidazoles Claim Types: Compound | FEB 11,2010 *PED | |
| Pat. No. 5153197 Treatment of hypertension with angiotensin II blocking imidazoles Claim Types: Composition; Method of use | APR 06,2010 *PED | U-3: Treatment of hypertension |
| Pat. No. 5210079 Treatment of chronic renal failure with imidazole angiotensin-II receptor antagonists Claim Types: Method of use | NOV 11,2010 *PED | U-496: Method for treating chronic renal failure |
| Pat. No. 5608075 Polymorphs of losartan and the process for the preparation of form II of losartan Claim Types: New polymorph, salt or hydrate; Composition; Process | SEP 04,2014 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Sep 11,2007 PED |
ACE INHIBITORS
DIOVAN HCT (TABLET) HYDROCHLOROTHIAZIDE; VALSARTAN
Drug Classes: DIURETICS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS NDA No.: 020818 Prod. No.: 001 RX (12.5MG;80MG); 002 RX (12.5MG;160MG); 003 RX (25MG;160MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5399578 Acyl compounds Claim Types: Compound; Composition; Method of use | MAR 21,2012 | U-3: Treatment of hypertension |
| Pat. No. 6294197 Solid oral dosage forms of valsartan Claim Types: Formulation; Method of use; Process | JUN 18,2017 | U-3: Treatment of hypertension |
ACE INHIBITORS
DIOVAN HCT (TABLET) HYDROCHLOROTHIAZIDE; VALSARTAN
Drug Classes: DIURETICS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS NDA No.: 020818 Prod. No.: 004 RX (12.5MG;320MG); 005 RX (25MG;320MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NS - New strength | APR 28,2009 |
ACE INHIBITORS
DIOVAN (CAPSULE) VALSARTAN
Drug Classes: ACE INHIBITORS
NDA Applicant: NOVARTIS NDA No.: 020665 Prod. No.: 001 DISC (80MG); 002 DISC (160MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5399578 Acyl compounds Claim Types: Compound; Composition; Method of use | MAR 21,2012 | U-3: Treatment of hypertension |
ACE INHIBITORS
EPZICOM (TABLET) ABACAVIR SULFATE; LAMIVUDINE
Drug Classes: ACE INHIBITORS
NDA Applicant: SMITHKLINE BEECHAM NDA No.: 021652 Prod. No.: 001 RX (EQ 600MG BASE;300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5034394 DS* DP* [Extended 905 days (2.5 years)] Therapeutic nucleosides Claim Types: Compound; Composition Comments: For its TRIZIVIR listing, the expiration date of this patent does not include the extension | JUN 18,2012 *PED | |
| Pat. No. 5047407 DS* DP* [Extended 282 days* (0.8 years)] 2-substituted-5-substituted-1,3-oxathiolanes with antiviral properties Claim Types: Compound; Composition | MAY 17,2010 *PED | U-257: Treatment of HIV infection |
| Pat. No. 5089500 Therapeutic nucleosides Claim Types: Method of use | DEC 26,2009 *PED | U-257: Treatment of HIV infection |
| Pat. No. 5905082 DS* DP* Crystalline oxathiolane derivatives Claim Types: Composition; Method of use | NOV 18,2016 *PED | |
| Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections Claim Types: Composition; Method of use | NOV 14,2018 *PED | U-257: Treatment of HIV infection |
| Pat. No. 6417191 DP* Synergistic combinations of zidovudine, 1592U89 and 3TC Claim Types: Method of use; Composition; Formulation | MAR 28,2016 | U-257: Treatment of HIV infection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | AUG 02,2007 | D-40: Once-a-day dosing regimen |
ACE INHIBITORS
LEXXEL (TABLET, EXTENDED RELEASE) ENALAPRIL MALEATE; FELODIPINE
Drug Classes: CALCIUM CHANNEL BLOCKERS; ACE INHIBITORS
NDA Applicant: ASTRAZENECA NDA No.: 020668 Prod. No.: 001 RX (5MG;5MG); 002 RX (5MG;2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4803081 New pharmaceutical preparations with extended release Claim Types: Formulation; Process | OCT 03,2007 *PED |
ACE INHIBITORS
LOTENSIN (TABLET) BENAZEPRIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS; HYPOTENSION/SHOCK
NDA Applicant: NOVARTIS NDA No.: 019851 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (40MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Sep 02,2007 PED | M-30: Changes to clinical pharmacology, precautions, and dosage and administration sections of labeling concerning use of LOTENSIN in pediatric patients with hypertension |
ACE INHIBITORS
LOTREL (CAPSULE) AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Drug Classes: CALCIUM CHANNEL BLOCKERS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS NDA No.: 020364 Prod. No.: 002 RX (EQ 2.5MG BASE;10MG); 003 RX (EQ 5MG BASE;10MG); 004 RX (EQ 5MG BASE;20MG); 005 RX (EQ 10MG BASE;20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4572909 [Extended 1252 days (3.4 years)] 2-(Secondary aminoalkoxymethyl) dihydropyridine derivatives as anti-ischaemic and antihypertensive agents Claim Types: Compound; Composition; Method of use Comments: Amlodipine and its salts, generally. | JUL 31,2006 | |
| Pat. No. 4879303 Pharmaceutically acceptable salts Claim Types: Compound;Composition; Formulation | MAR 25,2007 | |
| Pat. No. 6162802 Synergistic combination therapy using benazepril and amlodipine for the treatment of cardiovascular disorders and compositions therefor Claim Types: Method of use; Formulation | DEC 19,2017 | U-367: Treatment of cardiovascular disorders |
ACE INHIBITORS
LOTREL (CAPSULE) AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Drug Classes: CALCIUM CHANNEL BLOCKERS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS NDA No.: 020364 Prod. No.: 006 RX (EQ 10MG BASE;40MG); 007 RX (EQ 5MG BASE;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4879303 DS* DP* Pharmaceutically acceptable salts Claim Types: Compound;Composition; Formulation | MAR 25,2007 | |
| Pat. No. 6162802 DS* DP* Synergistic combination therapy using benazepril and amlodipine for the treatment of cardiovascular disorders and compositions therefor Claim Types: Method of use; Formulation | DEC 19,2017 | U-185: Method of treating hypertension |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NS - New strength | APR 11,2009 |
ACE INHIBITORS
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) |
ACE INHIBITORS
MICARDIS HCT (TABLET) HYDROCHLOROTHIAZIDE; TELMISARTAN
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021162 Prod. No.: 001 RX (12.5MG;40MG); 002 RX (12.5MG;80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5591762 Benzimidazoles useful as angiotensin-11 antagonists Claim Types: Compound; Composition; Method of use | JAN 07,2014 | U-3: Treatment of hypertension |
| Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation | JAN 10,2020 |
ACE INHIBITORS
MONOPRIL (TABLET) FOSINOPRIL SODIUM [GENERIC AB]
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES; HYPOTENSION/SHOCK
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. 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 |
ACE INHIBITORS
MONOPRIL-HCT (TABLET) FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE [GENERIC AB]
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. 5006344 Fosinopril tablet formulations Claim Types: Formulation | JAN 10,2010 *PED |
ACE INHIBITORS
PRINIVIL (TABLET) LISINOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: MERCK NDA No.: 019558 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (40MG) NDA No.: 019558 Prod. No.: 006 DISC (2.5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Nov 29,2006 PED |
ACE INHIBITORS
ZESTRIL (TABLET) LISINOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: ASTRAZENECA NDA No.: 019777 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (40MG); 005 RX (2.5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Nov 29,2006 PED |
ACE INHIBITORS
ZESTRIL (TABLET) LISINOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: ASTRAZENECA NDA No.: 019777 Prod. No.: 006 RX (30MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | MAY 29,2006 |
ACNE PRODUCTS
AVITA (CREAM) TRETINOIN [GENERIC AB]
Drug Classes: ACNE PRODUCTS; DERMATOLOGICS
NDA Applicant: MYLAN BERTEK NDA No.: 020404 Prod. No.: 003 RX (0.025%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4971800 Method and compositions for enhancing the cutaneous penetration of pharmacologically active agents Claim Types: Excipient; Method of administration | NOV 20,2007 | U-178: Facilitated adherence of agents to skin |
| Pat. No. 5045317 Enhancing the cutaneous penetration of pharmacologically active agents Claim Types: Formulation | SEP 03,2008 | U-179: Enhanced cutaneous penetration of a dermally-applied pharmacologically active agent |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code ODE: Orphan Drug | JUN 04,2008 |
ACNE PRODUCTS
DIFFERIN (GEL) ADAPALENE
Drug Classes: ACNE PRODUCTS
NDA Applicant: GALDERMA LABS LP NDA No.: 020380 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4717720 [Extended 1512 days (4.1 years)] Benzonaphthalene derivatives and compositions Claim Types: Compound; Composition | MAY 31,2010 | |
| Pat. No. RE34440 [Extended 433 days (1.2 years)] Benzonaphthalene derivatives, a process for their preparation and their use in therapeutic and cosmetic compositions Claim Types: Method of use; Composition | MAY 31,2010 | U-275: Method of use of the drug substance |
ACNE PRODUCTS
FINACEA (GEL) AZELAIC ACID
Drug Classes: ACNE PRODUCTS
NDA Applicant: INTENDIS NDA No.: 021470 Prod. No.: 001 RX (15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4713394 Treatment of nonacne inflammatory and infectious dermatoses and hair loss Claim Types: Method of use | JAN 17,2006 | U-492: Method for the treatment of skin, suffering from a condition selected from a group consisting of non-acne inflammatory dermatoses comprising applying to affected area a therapeutically effective amt azelaic acid |
| Pat. No. 6534070 Composition with azelaic acid Claim Types: Formulation; Method of use | NOV 18,2018 |
ACNE PRODUCTS
RETIN-A MICRO (GEL) TRETINOIN
Drug Classes: DERMATOLOGICS; ACNE PRODUCTS
NDA Applicant: JOHNSON AND JOHNSON NDA No.: 020475 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5955109 DP* Methods and compositions for topical delivery of retinoic acid Claim Types: Formulation; Method of administration | SEP 21,2016 | U-134: Treatment of acne vulgaris |
ACNE PRODUCTS
RETIN-A MICRO (GEL) TRETINOIN
Drug Classes: DERMATOLOGICS; ACNE PRODUCTS
NDA Applicant: JOHNSON AND JOHNSON NDA No.: 020475 Prod. No.: 002 RX (0.04%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5955109 Methods and compositions for topical delivery of retinoic acid Claim Types: Formulation; Method of administration | SEP 21,2016 | U-134: Treatment of acne vulgaris |
ACNE PRODUCTS
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 |
ACNE PRODUCTS
TAZORAC; AVAGE (CREAM) TAZAROTENE
Drug Classes: ACNE PRODUCTS
NDA Applicant: ALLERGAN NDA No.: 021184 Prod. No.: 001 RX (0.05%); 002 RX (0.1%); 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 |
ADRENAL CORTICOSTEROIDS
ELOCON (LOTION) MOMETASONE FUROATE [GENERIC AB]
Drug Classes: ADRENAL CORTICOSTEROIDS; DERMATOLOGICS
NDA Applicant: SCHERING NDA No.: 019796 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4775529 Steroid lotion Claim Types: Formulation; Method of use | NOV 21,2007 *PED |
ADRENAL CORTICOSTEROIDS
ELOCON (CREAM) MOMETASONE FUROATE [GENERIC AB]
Drug Classes: DERMATOLOGICS; ADRENAL CORTICOSTEROIDS; TOPICAL STEROIDS
NDA Applicant: SCHERING NDA No.: 019625 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4808610 Mometasone furoate anti-inflammatory cream composition using hexylene glycol Claim Types: Formulation | APR 02,2007 *PED |
ADRENAL CORTICOSTEROIDS
NASALIDE (SPRAY, METERED) FLUNISOLIDE [Has competitive generic]
Drug Classes: ADRENAL CORTICOSTEROIDS; NASAL DECONGESTANTS; CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: IVAX RES NDA No.: 018148 Prod. No.: 001 DISC (0.025MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4933168 Stable, crystalline flunisolide Claim Types: New polymorph, salt or hydrate; Formulation; Method of use | JUN 12,2007 |
ADRENAL CORTICOSTEROIDS
PREMARIN (TABLET) ESTROGENS, CONJUGATED
Drug Classes: ESTROGENS/PROGESTINS; ANTINEOPLASTICS; ADRENAL CORTICOSTEROIDS
NDA Applicant: WYETH PHARMS INC NDA No.: 004782 Prod. No.: 001 RX (1.25MG); 004 RX (0.625MG); 005 RX (0.9MG) NDA No.: 004782 Prod. No.: 002 DISC (2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5210081 Alkali metal 8,9-dehydroestrone sulfate esters Claim Types: Composition | FEB 26,2012 |
ADRENAL CORTICOSTEROIDS
PREMARIN (TABLET) ESTROGENS, CONJUGATED
Drug Classes: ESTROGENS/PROGESTINS; ANTINEOPLASTICS; ADRENAL CORTICOSTEROIDS
NDA Applicant: WYETH PHARMS INC NDA No.: 004782 Prod. No.: 006 RX (0.45MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: D - New Dosing Schedule | JUL 16,2006 | D-82: Use of PREMARIN 0.3 mg and 0.45 mg for the prevention of postmenopausal osteoporosis |
ADRENAL CORTICOSTEROIDS
PREMARIN (TABLET) ESTROGENS, CONJUGATED
Drug Classes: ESTROGENS/PROGESTINS; ANTINEOPLASTICS; ADRENAL CORTICOSTEROIDS
NDA Applicant: WYETH PHARMS INC NDA No.: 004782 Prod. No.: 003 RX (0.3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5210081 Alkali metal 8,9-dehydroestrone sulfate esters Claim Types: Composition | FEB 26,2012 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | JUL 16,2006 | D-82: Use of PREMARIN 0.3 mg and 0.45 mg for the prevention of postmenopausal osteoporosis |
ADRENAL CORTICOSTEROIDS
PULMICORT RESPULES (SUSPENSION) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA NDA No.: 020929 Prod. No.: 001 RX (0.25MG/2ML); 002 RX (0.5MG/2ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4787536 Dosage package Claim Types: Device; Process | AUG 27,2006 *PED | |
| Pat. No. 6598603 Method for treating respiratory diseases Claim Types: Method of use; Kit | JUN 23,2019 *PED | U-529: Once daily treatment of asthma with nebulized budesonide |
| Pat. No. 6899099 Method for treating a respiratory disease Claim Types: Kit; Method of use | JUN 23,2019 *PED | U-751: Once daily dosing of budesonide via nebulizer for the treatment of asthma |
ADRENAL CORTICOSTEROIDS
PULMICORT RESPULES (SUSPENSION) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA NDA No.: 020929 Prod. No.: 003 DISC (1MG/2ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4787536 Dosage package Claim Types: Device; Process | AUG 27,2006 *PED | |
| Pat. No. 6598603 Method for treating respiratory diseases Claim Types: Method of use; Kit | JUN 23,2019 *PED | U-529: Once daily treatment of asthma with nebulized budesonide |
ADRENAL CORTICOSTEROIDS
QVAR 80; QVAR 40 (AEROSOL, METERED) BECLOMETHASONE DIPROPIONATE
Drug Classes: ADRENAL CORTICOSTEROIDS; CORTICOSTEROIDS-INHALATION/NASAL; ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: 3M NDA No.: 020911 Prod. No.: 001 RX (0.08MG/INH); 002 RX (0.04MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5605674 Medicinal aerosol formulations Claim Types: Formulation | FEB 25,2014 | |
| Pat. No. 5683677 Medicinal aerosol formulations Claim Types: Formulation | NOV 04,2014 | |
| Pat. No. 5695743 Medicinal aerosol formulations Claim Types: Formulation; Method of administration; Method of use | JUL 06,2010 | |
| Pat. No. 5766573 Medicinal aerosol formulations Claim Types: Method of administration | NOV 28,2009 | U-356: Delivering a medicinal aerosol formulation using CFC-free propellant 134a. |
| Pat. No. 5776432 Beclomethasone solution aerosol formulations Claim Types: Formulation; Method of use | JUL 07,2015 | |
| Pat. No. 6352684 CRC-free medicinal aerosol formulations of 1,1,1,2-tetrafluoroethane (134A) with polar adjuvant Claim Types: Formulation | NOV 28,2009 |
ADRENAL CORTICOSTEROIDS
RHINOCORT (SPRAY, METERED) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS; CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: ASTRAZENECA NDA No.: 020746 Prod. No.: 001 RX (0.032MG/INH) NDA No.: 020746 Prod. No.: 002 DISC (0.064MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6291445 Low dose budesonide formulations and uses thereof Claim Types: Formulation; Drug in a container; Method of use | OCT 29,2017 *PED | |
| Pat. No. 6686346 DP* Formulation Claim Types: Formulation; Method of use; Device | APR 29,2017 | U-557: Nasal treatment of seasonal and perennial allergic rhinitis symptoms |
| Pat. No. 6986904 DP* Formulation Claim Types: Composition; Method of use; Formulation | APR 29,2017 | U-699: Nasal treatment of seasonal and perennial allergic rhinitis symptoms |
ALPHA AGONISTS/ALPHA BLOCKERS
CADUET (TABLET) AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Drug Classes: CALCIUM CHANNEL BLOCKERS; ALPHA AGONISTS/ALPHA BLOCKERS
NDA Applicant: PFIZER NDA No.: 021540 Prod. No.: 001 RX (EQ 5MG BASE;EQ 10MG BASE); 002 RX (EQ 5MG BASE;EQ 20MG BASE); 003 RX (EQ 5MG BASE;EQ 40MG BASE); 004 RX (EQ 5MG BASE;EQ 80MG BASE); 005 RX (EQ 10MG BASE;EQ 10MG BASE); 006 RX (EQ 10MG BASE;EQ 20MG BASE); 007 RX (EQ 10MG BASE;EQ 40MG BASE); 008 RX (EQ 10MG BASE;EQ 80MG BASE); 009 RX (EQ 2.5MG BASE;EQ 10MG BASE); 010 RX (EQ 2.5MG BASE;EQ 20MG BASE); 011 RX (EQ 2.5MG BASE;EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4572909 DS* DP* [Extended 1252 days (3.4 years)] 2-(Secondary aminoalkoxymethyl) dihydropyridine derivatives as anti-ischaemic and antihypertensive agents Claim Types: Compound; Composition; Method of use Comments: Amlodipine and its salts, generally. | JAN 31,2007 *PED | U-3: Treatment of hypertension |
| Pat. No. 4681893 DS* DP* [Extended 1213 days (3.3 years)] Trans-6-[2-(3- or 4-carboxamido-substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-one inhibitors of cholesterol synthesis Claim Types: Compound; Composition; Method of use | MAR 24,2010 *PED | U-161: Method of inhibiting cholesterol biosynthesis in a patient |
| Pat. No. 4879303 DS* DP* Pharmaceutically acceptable salts Claim Types: Compound;Composition; Formulation | SEP 25,2007 *PED | |
| Pat. No. 5273995 DS* DP* [R-(R*R*)]-2-(4-fluorophenyl)-.beta.,.delta.-dihydroxy-5- (1-methylethyl-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, its lactone form and salts thereof Claim Types: Compound; Composition; Method of use Comments: Specific stereoisomer of atorvastatin | JUN 28,2011 *PED | U-162: Method of use to inhibit cholesterol synthesis in a human suffering from hypercholesterolemia |
| Pat. No. 5686104 DP* Stable oral CI-981 formulation and process of preparing same Claim Types: Formulation; Process; Method of use | MAY 11,2015 *PED | U-213: Method of inhibiting cholesterol biosynthesis and treating hypercholesterolemia and method for treating hyperlipidemia |
| Pat. No. 5969156 DS* Crystalline [R-(R*,R*)]-2-(4-Dfluorophenyl)- .beta.,.delta.-dihydroxy-5-(1-methylethyl)-3-phenyl- 4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin) Claim Types: New polymorph, salt or hydrate | JAN 08,2017 *PED | |
| Pat. No. 6126971 DP* Stable oral CI-981 formulation and process for preparing same Claim Types: Formulation; Method of improving a formulation | JUL 19,2013 *PED | |
| Pat. No. 6455574 Therapeutic combination Claim Types: Method of use | AUG 11,2018 | U-552: Treatment of hypertension and hyperlipidemia with a single composition |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | JAN 30,2007 |
ALPHA AGONISTS/ALPHA BLOCKERS
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 |
ALPHA AGONISTS/ALPHA BLOCKERS
MICARDIS (TABLET) TELMISARTAN
Drug Classes: ANTIHYPERTENSIVES; ALPHA AGONISTS/ALPHA BLOCKERS
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 020850 Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5591762 Benzimidazoles useful as angiotensin-11 antagonists Claim Types: Compound; Composition; Method of use | JAN 07,2014 | U-3: Treatment of hypertension |
| Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation | JAN 10,2020 |
ALZHEIMER-TYPE DEMENTIA
ARICEPT (TABLET) DONEPEZIL HYDROCHLORIDE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: EISAI MEDCL RES NDA No.: 020690 Prod. No.: 001 RX (10MG); 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4895841 [Extended 888 days* (2.4 years)] Cyclic amine compounds with activity against acetylcholinesterase Claim Types: Compound; Composition; Method of use | NOV 25,2010 | |
| Pat. No. 5985864 Polymorphs of donepezil hydrochloride and process for production Claim Types: New polymorph, salt or hydrate; Composition; Process; Method of use | DEC 30,2016 | |
| Pat. No. 6140321 Polymorphs of donepezil hydrochloride and process for production Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process | DEC 30,2016 | |
| Pat. No. 6245911 Donepezil polycrystals and process for producing the same Claim Types: New polymorph, salt or hydrate; Process | DEC 01,2018 | |
| Pat. No. 6372760 Stabilized composition comprising antidementia medicament Claim Types: Formulation; Method of improving a formulation | MAR 31,2019 |
ALZHEIMER-TYPE DEMENTIA
EXELON (CAPSULE) RIVASTIGMINE TARTRATE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: NOVARTIS NDA No.: 020823 Prod. No.: 003 RX (EQ 1.5MG BASE); 004 RX (EQ 3MG BASE); 005 RX (EQ 4.5MG BASE); 006 RX (EQ 6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4948807 DS* Phenyl carbamates Claim Types: Compound; Method of use | AUG 14,2012 | U-322: Treatment of Alzheimer's dementia |
| Pat. No. 5602176 Phenyl carbamate Claim Types: Compound; Method of use | FEB 11,2014 | U-322: Treatment of Alzheimer's dementia |
ALZHEIMER-TYPE DEMENTIA
RAZADYNE (TABLET) GALANTAMINE HYDROBROMIDE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: JANSSEN PHARMA NDA No.: 021169 Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 8MG BASE); 003 RX (EQ 12MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4663318 [Extended 1064 days (2.9 years)] Method of treating Alzheimer's disease Claim Types: Method of use | DEC 14,2008 | U-322: Treatment of Alzheimer's dementia |
| Pat. No. 6099863 Fast-dissolving galanthamine hydrobromide tablet Claim Types: Formulation | JUN 06,2017 | |
| Pat. No. |