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. 6358527 DP* Fast-dissolving galanthamine hydrobromide tablet Claim Types: Method of use; Formulation | JUN 06,2017 | U-322: Treatment of Alzheimer's dementia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | FEB 28,2006 |
ALZHEIMER-TYPE DEMENTIA
RAZADYNE (SOLUTION) GALANTAMINE HYDROBROMIDE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: JANSSEN PHARMA NDA No.: 021224 Prod. No.: 001 RX (4MG/ML)
| 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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | FEB 28,2006 |
ANALGESICS, GENERAL
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 |
ANALGESICS, GENERAL
AVINZA (CAPSULE, EXTENDED RELEASE) MORPHINE SULFATE
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: LIGAND NDA No.: 021260 Prod. No.: 001 RX (30MG); 002 RX (60MG); 003 RX (90MG); 004 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6066339 Oral morphine multiparticulate formulation Claim Types: Formulation | NOV 25,2017 |
ANALGESICS, GENERAL
BEXTRA (TABLET) VALDECOXIB
Drug Classes: ANALGESICS, GENERAL; NSAID
NDA Applicant: SEARLE, GD LLC NDA No.: 021341 Prod. No.: 002 RX (10MG); 003 RX (20MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5633272 Substituted isoxazoles for the treatment of inflammation Claim Types: Compound; Composition; Method of use | FEB 13,2015 | U-462: Signs and symptoms of osteoarthritis and adult rheumatoid arthritis and treatment of primary dysmenorrhea |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | NOV 16,2006 |
ANALGESICS, GENERAL
CELEBREX (CAPSULE) CELECOXIB
Drug Classes: NSAID; ANALGESICS, GENERAL
NDA Applicant: SEARLE, GD LLC NDA No.: 020998 Prod. No.: 002 RX (200MG); 003 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5466823 DS* Substituted pyrazolyl benzenesulfonamides Claim Types: Compound | MAY 30,2014 *PED | |
| Pat. No. 5563165 DP* Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation Claim Types: Composition | MAY 30,2014 *PED | |
| Pat. No. 5760068 Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation Claim Types: Method of use | DEC 02,2015 *PED | U-299: Treatment of adenomatous polyps |
| Pat. No. 5972986 Method of using cyclooxygenase-2 inhibitors in the treatment and prevention of neoplasia Claim Types: Method of use | APR 14,2018 *PED | U-299: Treatment of adenomatous polyps |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 29,2009 PED | I-466: For relief of the signs and symptoms of ankylosing spondylitis |
ANALGESICS, GENERAL
CELEBREX (CAPSULE) CELECOXIB
Drug Classes: NSAID; ANALGESICS, GENERAL
NDA Applicant: SEARLE, GD LLC NDA No.: 020998 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5466823 DS* Substituted pyrazolyl benzenesulfonamides Claim Types: Compound | MAY 30,2014 *PED | |
| Pat. No. 5563165 DP* Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation Claim Types: Composition | MAY 30,2014 *PED | |
| Pat. No. 5760068 Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation Claim Types: Method of use | DEC 02,2015 *PED | U-672: Treatment of inflammation or an inflammation-associated disorder |
| Pat. No. 5972986 Method of using cyclooxygenase-2 inhibitors in the treatment and prevention of neoplasia Claim Types: Method of use | APR 14,2018 *PED | U-299: Treatment of adenomatous polyps |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jan 29,2009 PED | I-466: For relief of the signs and symptoms of ankylosing spondylitis |
ANALGESICS, GENERAL
DURAGESIC-100; DURAGESIC-75; DURAGESIC-50; DURAGESIC-25; DURAGESIC-12 (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); 005 RX (12.5UGM/HR)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Nov 20,2006 PED |
ANALGESICS, GENERAL
MOTRIN, JUNIOR STRENGTH (SUSPENSION) IBUPROFEN [GENERIC AB]
Drug Classes: ANALGESICS-NON-NARCOTIC; ANTIPYRETICS; ANALGESICS, GENERAL
NDA Applicant: MCNEIL CONS SPECLT NDA No.: 019842 Prod. No.: 001 RX (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5374659 Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives Claim Types: Formulation | JUN 20,2012 *PED |
ANALGESICS, GENERAL
OXYCONTIN (TABLET, EXTENDED RELEASE) OXYCODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS, GENERAL; ANALGESICS-NARCOTIC
NDA Applicant: PURDUE PHARMA LP NDA No.: 020553 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG) NDA No.: 020553 Prod. No.: 005 DISC (160MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4861598 Controlled release bases for pharmaceuticals Claim Types: Formulation | AUG 29,2006 | |
| Pat. No. 4970075 Controlled release bases for pharmaceuticals Claim Types: Formulation | AUG 29,2006 | |
| Pat. No. 5266331 Controlled release oxycodone compositions Claim Types: Formulation; Process | OCT 26,2007 | |
| Pat. No. 5508042 Controlled release oxycodone compositions Claim Types: Method of use | APR 16,2013 | U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time |
| Pat. No. 5549912 Controlled release oxycodone compositions Claim Types: Formulation | OCT 26,2007 | |
| Pat. No. 5656295 Controlled release oxycodone compositions Claim Types: Formulation; Method of use | OCT 26,2007 | U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time |
ANALGESICS, GENERAL
PRECEDEX (INJECTABLE) DEXMEDETOMIDINE
Drug Classes: SEDATIVES/HYPNOTICS; ANALGESICS, GENERAL
NDA Applicant: HOSPIRA NDA No.: 021038 Prod. No.: 001 RX (EQ 100UGM BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4910214 DS* DP* Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist Claim Types: Compound; Method of use | JUL 15,2013 | U-421: Use for sedation |
| Pat. No. 6716867 Use of dexmedetomidine for ICU sedation Claim Types: Method of use | MAR 31,2019 | U-572: Intensive care unit sedation |
ANALGESICS, GENERAL
SUBOXONE (TABLET) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug Classes: ANTIDOTES, SPECIFIC; ANALGESICS, GENERAL
NDA Applicant: RECKITT BENCKISER NDA No.: 020733 Prod. No.: 001 RX (2MG;0.5MG); 002 RX (8MG;2MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code ODE: Orphan Drug | OCT 08,2009 | Treatment of opiate addiction in opiate users. |
ANALGESICS, GENERAL
SUBUTEX (TABLET) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: RECKITT BENCKISER NDA No.: 020732 Prod. No.: 002 RX (EQ 2MG BASE); 003 RX (EQ 8MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code ODE: Orphan Drug | OCT 08,2009 | Treatment of opiate addiction in opiate users. |
ANALGESICS, GENERAL
ULTRACET (TABLET) ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: ORTHO MCNEIL PHARM NDA No.: 021123 Prod. No.: 001 RX (325MG;37.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE39221 DS* DP* Composition comprising a tramadol material and acetaminophen and its use Claim Types: Formulation; Method of use | AUG 09,2011 | U-55: Treatment of pain |
ANALGESICS-NARCOTIC
ACTIQ (SUGAR-FREE) (TROCHE/LOZENGE) FENTANYL CITRATE
Drug Classes: ANALGESICS-NARCOTIC
NDA Applicant: CEPHALON NDA No.: 020747 Prod. No.: 001 RX (EQ 0.2MG BASE); 002 RX (EQ 0.4MG BASE); 003 RX (EQ 0.6MG BASE); 004 RX (EQ 0.8MG BASE); 005 RX (EQ 1.2MG BASE); 006 RX (EQ 1.6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4863737 Compositions and methods of manufacture of compressed powder medicaments Claim Types: Device; Process | SEP 05,2006 |
ANALGESICS-NARCOTIC
DURAGESIC-100; DURAGESIC-75; DURAGESIC-50; DURAGESIC-25; DURAGESIC-12 (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); 005 RX (12.5UGM/HR)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Nov 20,2006 PED |
ANALGESICS-NARCOTIC
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); 004 RX (30MG); 005 RX (60MG)
| 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 |
ANALGESICS-NARCOTIC
OXYCONTIN (TABLET, EXTENDED RELEASE) OXYCODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS, GENERAL; ANALGESICS-NARCOTIC
NDA Applicant: PURDUE PHARMA LP NDA No.: 020553 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG) NDA No.: 020553 Prod. No.: 005 DISC (160MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4861598 Controlled release bases for pharmaceuticals Claim Types: Formulation | AUG 29,2006 | |
| Pat. No. 4970075 Controlled release bases for pharmaceuticals Claim Types: Formulation | AUG 29,2006 | |
| Pat. No. 5266331 Controlled release oxycodone compositions Claim Types: Formulation; Process | OCT 26,2007 | |
| Pat. No. 5508042 Controlled release oxycodone compositions Claim Types: Method of use | APR 16,2013 | U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time |
| Pat. No. 5549912 Controlled release oxycodone compositions Claim Types: Formulation | OCT 26,2007 | |
| Pat. No. 5656295 Controlled release oxycodone compositions Claim Types: Formulation; Method of use | OCT 26,2007 | U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time |
ANALGESICS-NARCOTIC
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 |
ANALGESICS-NON-NARCOTIC
MOTRIN, JUNIOR STRENGTH (SUSPENSION) IBUPROFEN [GENERIC AB]
Drug Classes: ANALGESICS-NON-NARCOTIC; ANTIPYRETICS; ANALGESICS, GENERAL
NDA Applicant: MCNEIL CONS SPECLT NDA No.: 019842 Prod. No.: 001 RX (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5374659 Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives Claim Types: Formulation | JUN 20,2012 *PED |
ANALGESICS-NON-NARCOTIC
QUADRAMET (INJECTABLE) SAMARIUM SM 153 LEXIDRONAM PENTASODIUM
Drug Classes: ANALGESICS-NON-NARCOTIC
NDA Applicant: CYTOGEN NDA No.: 020570 Prod. No.: 001 RX (50mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4898724 [Extended 1511 days (4.1 years)] Organis amine phosphonic acid complexes for the treatment of calcific tumors Claim Types: Method of use; Formulation Comments: Orange Book expiration date does not include extension. Extended expiration date is March 28, 2011. | FEB 06,2007 | U-187: Therapeutic treatment of calcific tumors |
ANALGESICS-NON-NARCOTIC
ULTRAM (TABLET) TRAMADOL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS-NON-NARCOTIC
NDA Applicant: ORTHO MCNEIL PHARM NDA No.: 020281 Prod. No.: 002 RX (50MG) NDA No.: 020281 Prod. No.: 001 DISC (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6339105 Analgesic regimen Claim Types: Method of administration | APR 12,2020 *PED | U-435: A titration dosing regimen for the treatment of pain using an initial dose of about 25mg |
ANDROGENS/ANABOLIC STEROIDS
ANDRODERM (FILM, EXTENDED RELEASE) TESTOSTERONE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: WATSON LABS NDA No.: 020489 Prod. No.: 001 RX (2.5MG/24HR); 002 RX (5MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4849224 Device for administering an active agent to the skin or mucosa Claim Types: Device | NOV 12,2007 | |
| Pat. No. 4855294 Method for reducing skin irritation associated with drug/penetration enhancer compositions Claim Types: Formulation; Method of use | SEP 06,2008 | |
| Pat. No. 4863970 Penetration enhancement with binary system of oleic acid, oleins, and oleyl alcohol with lower alcohols Claim Types: Formulation | NOV 14,2006 | |
| Pat. No. 4983395 Device for administering an active agent to the skin or mucosa Claim Types: Device | NOV 12,2007 | |
| Pat. No. 5152997 Method and device for transdermally administering testosterone across nonscrotal skin at therapeutically effective levels Claim Types: Device; Method of use | DEC 11,2010 | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 5164190 Subsaturated transdermal drug delivery device exhibiting enhanced drug flux Claim Types: Device; Method of administration | DEC 11,2010 |
ANDROGENS/ANABOLIC STEROIDS
ANDROGEL (GEL) TESTOSTERONE [GENERIC AB]
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: UNIMED PHARMS NDA No.: 021015 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration | AUG 30,2020 | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
ANDROGENS/ANABOLIC STEROIDS
CASODEX (TABLET) BICALUTAMIDE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: ASTRAZENECA NDA No.: 020498 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4636505 [Extended 1723 days (4.7 years)] Amide derivatives Claim Types: Compound; Composition; Method of use | OCT 01,2008 |
ANDROGENS/ANABOLIC STEROIDS
OXANDRIN (TABLET) OXANDROLONE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS; HORMONES/HORMONAL MECHANISMS
NDA Applicant: SAVIENT PHARMS NDA No.: 013718 Prod. No.: 001 RX (2.5MG); 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5872147 Use of oxandrolone in the treatment of chronic obstructive pulmonary disease Claim Types: Method of use | DEC 05,2017 | U-585: To promote weight gain after weight loss in certain types of patients |
| Pat. No. 6090799 Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1 Claim Types: Method of use | JUL 18,2017 | U-585: To promote weight gain after weight loss in certain types of patients |
| Pat. No. 6576659 Use of oxandrolone in the treatment of burns an other wounds Claim Types: Method of use | DEC 05,2017 | U-585: To promote weight gain after weight loss in certain types of patients |
| Pat. No. 6670351 Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1 Claim Types: Method of use | OCT 20,2012 | U-585: To promote weight gain after weight loss in certain types of patients |
| Pat. No. 6828313 Use of oxandrolone in the treatment of burns and other wounds Claim Types: Method of use | DEC 05,2017 | U-585: To promote weight gain after weight loss in certain types of patients |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | JUN 20,2008 | M-42: Addition of a geriatric use subsection to the precautions section of the package insert and geriatric dosing information |
ANDROGENS/ANABOLIC STEROIDS
PROPECIA (TABLET) FINASTERIDE [GENERIC AB]
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: MERCK NDA No.: 020788 Prod. No.: 001 RX (1MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4760071 [Extended 328 days (0.9 years)] 17.beta.-N-monosubstituted carbamoyl-4-aza-5.alpha.-androst-1-en-3-ones which are active as testosterone 5.alpha.-reductase inhibitors Claim Types: Compound; Composition; Method of use | JUN 19,2006 | |
| Pat. No. 5547957 Method of treating androgenic alopecia with 5-.alpha. reductase inhibitors Claim Types: Method of use | OCT 15,2013 | U-236: Treating male pattern baldness with 0.05 to 3.0 mg/day |
| Pat. No. 5571817 Methods of treating androgenic alopecia with finasteride [17.beta.-N-mono-substituted-carbamoyl-4-aza-5-.alpha.-androst-1-en-ones] Claim Types: Method of use | NOV 05,2013 | U-259: Treatment of androgenic alopecia by oral administration of drug substance |
| Pat. No. 5886184 Finasteride processes Claim Types: New polymorph, salt or hydrate; Product-by-process; Process | NOV 19,2012 |
ANDROGENS/ANABOLIC STEROIDS
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. 5840327 Transdermal drug delivery device having enhanced adhesion Claim Types: Device | AUG 15,2016 |
ANESTHESIA, ADJUNCTS TO/ANALEPTICS
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 |
ANESTHESIA, ADJUNCTS TO/ANALEPTICS
ZEMURON (INJECTABLE) ROCURONIUM BROMIDE
Drug Classes: ANESTHESIA, ADJUNCTS TO/ANALEPTICS
NDA Applicant: ORGANON USA INC NDA No.: 020214 Prod. No.: 001 RX (50MG/5ML(10MG/ML)); 003 RX (100MG/10ML(10MG/ML)) NDA No.: 020214 Prod. No.: 002 DISC (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4894369 Novel 2.beta.-morpholino-androstane derivatives Claim Types: Compound; Composition | APR 13,2008 |
ANESTHETICS, GENERAL
DIPRIVAN (INJECTABLE) PROPOFOL [GENERIC AB]
Drug Classes: ANESTHETICS, GENERAL
NDA Applicant: ABRAXIS BIOSCIENCE NDA No.: 019627 Prod. No.: 002 RX (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5714520 Propofol compostion containing edetate Claim Types: Formulation | SEP 22,2015 *PED | |
| Pat. No. 5731355 Pharmaceutical compositions of propofol and edetate Claim Types: Method of use | SEP 22,2015 *PED | U-217: Method of producing anesthesia |
| Pat. No. 5731356 Pharmaceutical compositions of propofol and edetate Claim Types: Process | SEP 22,2015 *PED | U-218: Method for limiting the potential for microbial growth in the drug product |
| Pat. No. 5908869 Propofol compositions containing edetate Claim Types: Process | SEP 22,2015 *PED | U-270: Method of improving the time for administration or the time between changes of giving sets for the drug product |
ANESTHETICS, GENERAL
SUPRANE (LIQUID) DESFLURANE
Drug Classes: ANESTHETICS, GENERAL
NDA Applicant: BAXTER HLTHCARE CORP NDA No.: 020118 Prod. No.: 001 RX (99.9%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4762856 [Extension length not available] Anesthetic composition and method of using the same Claim Types: Method of use | FEB 02,2007 | U-67: Method of inducing anesthesia in a warm blooded animal |
| Pat. No. 5617906 DP* Container for anaesthetic agent Claim Types: Device | APR 08,2014 |
ANESTHETICS, GENERAL
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 |
ANESTHETICS, LOCAL
CHIROCAINE (INJECTABLE) LEVOBUPIVACAINE HYDROCHLORIDE
Drug Classes: ANESTHETICS, LOCAL
NDA Applicant: PURDUE PHARMA LP NDA No.: 020997 Prod. No.: 001 DISC (EQ 2.5MG BASE/ML); 002 DISC (EQ 5MG BASE/ML); 003 DISC (EQ 7.5MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5708011 Use of levobupivacaine in a patient having depressed myocardial contractility Claim Types: Method of use | OCT 13,2014 | U-276: Method of use of levobupivacaine |
ANESTHETICS, LOCAL
LIDOCAINE (FILM, EXTENDED RELEASE) LIDOCAINE
Drug Classes: ANESTHETICS, LOCAL
NDA Applicant: NOVEN NDA No.: 020575 Prod. No.: 002 RX (46.1MG/PATCH) NDA No.: 020575 Prod. No.: 001 DISC (23MG/PATCH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5234957 Compositions and methods for topical administration of pharmaceutically active agents Claim Types: Formulation | FEB 27,2011 | |
| Pat. No. 5332576 Compositions and methods for topical administration of pharmaceutically active agents Claim Types: Method of administration | JUL 26,2011 | |
| Pat. No. 5446070 Compositions and methods for topical administration of pharmaceutically active agents Claim Types: Device; Formulation | FEB 27,2011 |
ANESTHETICS, LOCAL
NAROPIN (INJECTABLE) ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
Drug Classes: ANESTHETICS, LOCAL; ANTISEPTICS/DISINFECTANTS; ANTIASTHMATICS/BRONCODILATORS; PHARMACEUTICAL AIDS; SURGICAL AIDS
NDA Applicant: ABRAXIS BIOSCIENCE NDA No.: 020533 Prod. No.: 001 RX (2MG/ML); 003 RX (5MG/ML); 004 RX (7.5MG/ML); 005 RX (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4870086 [Extended 1400 days* (3.8 years)] Optically pure compound and a process for its preparation Claim Types: Compound; Process; Method of use | SEP 24,2010 |
ANESTHETICS, LOCAL
ORAQIX (GEL) LIDOCAINE; PRILOCAINE
Drug Classes: ANESTHETICS, LOCAL
NDA Applicant: DENTSPLY PHARM NDA No.: 021451 Prod. No.: 001 RX (2.5%;2.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6031007 DP* Pharmaceutical composition with anaesthetic effect Claim Types: Formulation; Method of use; Process | APR 01,2017 | U-553: Management of pain and discomfort associated with peridontal scaling and root planning procedures by application of an eutectic mixture of local anesthetics to peridontal pockets |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | DEC 19,2006 |
ANESTHETICS, TOPICAL
LIDODERM (PATCH) LIDOCAINE
Drug Classes: ANESTHETICS, TOPICAL
NDA Applicant: TEIKOKU PHARMA USA NDA No.: 020612 Prod. No.: 001 RX (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5411738 Method for treating nerve injury pain associated with shingles (herpes-zoster and post-herpetic neuralgia) by topical application of lidocaine Claim Types: Formulation; Method of use | MAY 02,2012 | |
| Pat. No. 5589180 Method for treating nerve injury pain associated with shingles (herpes-zoster and post-herpetic neuralgia) by topical application of lidocaine Claim Types: Formulation | MAR 17,2009 | U-485: Method and composition for reducing nerve injury pain associated with Shingles (Herpes Zoster and Post-Herpetic Neuralgia) |
| Pat. No. 5601838 Method for treating pain associated with herpes-zoster and post-herpetic neuralgia Claim Types: Method of use | MAY 02,2012 | U-488: Method for reducing the pain associated with Herpes-Zoster and Post-Herpetic Neuralgia |
| Pat. No. 5709869 Method for treating nerve injury pain associated with shingles Claim Types: Method of use | MAR 17,2009 | U-485: Method and composition for reducing nerve injury pain associated with Shingles (Herpes Zoster and Post-Herpetic Neuralgia) |
| Pat. No. 5827529 External preparation for application to the skin containing lidocaine Claim Types: Formulation | OCT 27,2015 | U-486: External preparation for application to the skin containing lidocaine-drug retaining layer placed on support and comprises adhesive gel base 1-10% by weight of lidocaine |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code ODE: Orphan Drug | MAR 19,2006 | For relief of allodynia (painful hypersensitivity), and chronic pain in post-herpetic neuralgia. |
ANOREXIANTS/CNS STIMULANTS
ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB]
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: SHIRE NDA No.: 011522 Prod. No.: 007 RX (2.5MG;2.5MG;2.5MG;2.5MG); 008 RX (5MG;5MG;5MG;5MG); 009 RX (1.25MG;1.25MG;1.25MG;1.25MG); 010 RX (7.5MG;7.5MG;7.5MG;7.5MG); 011 RX (1.875MG;1.875MG;1.875MG;1.875MG); 012 RX (3.125MG;3.125MG;3.125MG;3.125MG); 013 RX (3.75MG;3.75MG;3.75MG;3.75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6384020 Rapid immediate release oral dosage form Claim Types: Formulation | JAN 06,2021 *PED |
ANOREXIANTS/CNS STIMULANTS
ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: SHIRE NDA No.: 021303 Prod. No.: 001 RX (2.5MG;2.5MG;2.5MG;2.5MG); 002 RX (5MG;5MG;5MG;5MG); 003 RX (7.5MG;7.5MG;7.5MG;7.5MG); 004 RX (6.25MG;6.25MG;6.25MG;6.25MG); 005 RX (1.25MG;1.25MG;1.25MG;1.25MG); 006 RX (3.75MG;3.75MG;3.75MG;3.75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6322819 Oral pulsed dose drug delivery system Claim Types: Formulation | APR 21,2019 *PED | |
| Pat. No. 6605300 Oral pulsed dose drug delivery system Claim Types: Formulation | APR 21,2019 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | AUG 11,2007 | |
| Exclusivity Code: NPP - New patient population | Jan 21,2009 PED |
ANOREXIANTS/CNS STIMULANTS
CAFCIT (SOLUTION) CAFFEINE CITRATE
Drug Classes: ANOREXIANTS/CNS STIMULANTS; ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: MEAD JOHNSON NDA No.: 020793 Prod. No.: 001 RX (EQ 30MG BASE/3ML (EQ 10MG BASE/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code ODE: Orphan Drug | SEP 21,2006 | Treatment of apnea of prematurity. |
ANOREXIANTS/CNS STIMULANTS
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 |
| Pat. No. 6930129 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 |
ANOREXIANTS/CNS STIMULANTS
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 |
ANOREXIANTS/CNS STIMULANTS
METADATE CD (CAPSULE, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: UCB INC NDA No.: 021259 Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (10MG); 004 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6344215 DP* Methylphenidate modified release formulations Claim Types: Formulation | OCT 27,2020 |
ANOREXIANTS/CNS STIMULANTS
RITALIN LA (CAPSULE, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: NOVARTIS NDA No.: 021284 Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5837284 DP* Delivery of multiple doses of medications Claim Types: Formulation | DEC 04,2015 | |
| Pat. No. 6228398 DP* Multiparticulate modified release composition Claim Types: Formulation; Method of use | NOV 01,2019 | U-472: Treatment of attention deficit hyperactivity disorder using methylphenidate bi-modal release profile extended-release capsules |
| Pat. No. 6635284 DP* Delivery of multiple doses of medications Claim Types: Method of administration; Formulation | DEC 04,2015 | U-591: Treatment of attention deficit hyperactivity disorder using a dosage form which provides once-daily oral administration of a phenidate drug |
ANOREXIANTS/CNS STIMULANTS
RITALIN LA (CAPSULE, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: NOVARTIS NDA No.: 021284 Prod. No.: 004 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5837284 DP* Delivery of multiple doses of medications Claim Types: Formulation | DEC 04,2015 | |
| Pat. No. 6228398 DP* Multiparticulate modified release composition Claim Types: Formulation; Method of use | NOV 01,2019 | |
| Pat. No. 6635284 DP* Delivery of multiple doses of medications Claim Types: Method of administration; Formulation | DEC 04,2015 | U-591: Treatment of attention deficit hyperactivity disorder using a dosage form which provides once-daily oral administration of a phenidate drug |
ANOREXIANTS/CNS STIMULANTS
XENICAL (CAPSULE) ORLISTAT
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: HLR NDA No.: 020766 Prod. No.: 001 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4598089 [Extended 5 years] Leucine derivatives Claim Types: Compound; Composition; Method of use | DEC 18,2009 *PED | |
| Pat. No. 6004996 Tetrahydrolipstatin containing compositions Claim Types: Formulation | JUL 06,2018 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 12,2007 PED | M-29: Labeling changes to provide information in the management of obesity in adolescents aged 12 to 16 years |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GANIRELIX ACETATE INJECTION (INJECTABLE) GANIRELIX ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; INFERTILITY
NDA Applicant: ORGANON USA INC NDA No.: 021057 Prod. No.: 001 RX (EQ 250UGM BASE/0.5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4801577 DS* DP* [Extended 5 years] Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists Claim Types: Compound; Composition | FEB 05,2012 | |
| Pat. No. 5767082 Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists Claim Types: Method of use | JUN 16,2015 |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GENOTROPIN PRESERVATIVE FREE (INJECTABLE) SOMATROPIN RECOMBINANT
Drug Classes: DRUGS USED IN DISORDERS OF GROWTH HORMONE SECRETION; ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 020280 Prod. No.: 001 RX (0.2MG/VIAL); 002 RX (0.4MG/VIAL); 003 RX (0.6MG/VIAL); 005 RX (0.8MG/VIAL); 008 RX (1MG/VIAL); 009 RX (1.2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4968299 DP* Method and device for injection Claim Types: Device; Process | JUN 28,2008 | |
| Pat. No. 5435076 DP* Injection device Claim Types: Device; Process | APR 16,2013 | |
| Pat. No. 5716338 DP* Dual-chamber type injection cartridge with bypass connection Claim Types: Device | FEB 10,2015 | |
| Pat. No. 6152897 DP* Syringe Claim Types: Device | NOV 20,2018 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | APR 27,2009 | I-496: Long term treatment of growth failure associated with Turner syndrome in patients who have open epiphyses |
| Exclusivity Code ODE: Orphan Drug | JUL 25,2008 | Treatment of growth failure in children who were born small for gestational age. |
| Exclusivity Code ODE: Orphan Drug | JUN 20,2007 | Treatment of short stature in patients with Prader-Willi syndrome. |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GENOTROPIN PRESERVATIVE FREE (INJECTABLE) SOMATROPIN RECOMBINANT
Drug Classes: DRUGS USED IN DISORDERS OF GROWTH HORMONE SECRETION; ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 020280 Prod. No.: 010 RX (1.4MG/VIAL); 011 RX (1.6MG/VIAL); 012 RX (1.8MG/VIAL); 013 RX (2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4968299 DP* Method and device for injection Claim Types: Device; Process | JUN 28,2008 | |
| Pat. No. 5435076 DP* Injection device Claim Types: Device; Process | APR 16,2013 | |
| Pat. No. 5716338 DP* Dual-chamber type injection cartridge with bypass connection Claim Types: Device | FEB 10,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | APR 27,2009 | I-496: Long term treatment of growth failure associated with Turner syndrome in patients who have open epiphyses |
| Exclusivity Code ODE: Orphan Drug | JUL 25,2008 | Treatment of growth failure in children who were born small for gestational age. |
| Exclusivity Code ODE: Orphan Drug | JUN 20,2007 | Treatment of short stature in patients with Prader-Willi syndrome. |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GENOTROPIN PRESERVATIVE FREE (INJECTABLE) SOMATROPIN RECOMBINANT
Drug Classes: DRUGS USED IN DISORDERS OF GROWTH HORMONE SECRETION; ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 020280 Prod. No.: 004 RX (1.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4968299 DP* Method and device for injection Claim Types: Device; Process | JUN 28,2008 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | APR 27,2009 | I-496: Long term treatment of growth failure associated with Turner syndrome in patients who have open epiphyses |
| Exclusivity Code ODE: Orphan Drug | JUL 25,2008 | Treatment of growth failure in children who were born small for gestational age. |
| Exclusivity Code ODE: Orphan Drug | JUN 20,2007 | Treatment of short stature in patients with Prader-Willi syndrome. |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GENOTROPIN (INJECTABLE) SOMATROPIN RECOMBINANT
Drug Classes: DRUGS USED IN DISORDERS OF GROWTH HORMONE SECRETION; ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 020280 Prod. No.: 006 RX (5.8MG/VIAL); 007 RX (13.8MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4968299 DP* Method and device for injection Claim Types: Device; Process | JUN 28,2008 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | APR 27,2009 | I-496: Long term treatment of growth failure associated with Turner syndrome in patients who have open epiphyses |
| Exclusivity Code ODE: Orphan Drug | JUL 25,2008 | Treatment of growth failure in children who were born small for gestational age. |
| Exclusivity Code ODE: Orphan Drug | JUN 20,2007 | Treatment of short stature in patients with Prader-Willi syndrome. |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GONAL-F RFF (INJECTABLE) FOLLITROPIN ALFA/BETA
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; PHARMACEUTICAL AIDS
NDA Applicant: SERONO INC NDA No.: 021765 Prod. No.: 002 RX (75 IU/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5767067 DS* Follicle stimulating hormone and pharmaceutical compositions containing same Claim Types: Composition | JUN 16,2015 | |
| Pat. No. 5767251 DS* Recombinant heterodimeric human fertility hormones, and methods, cells, and vectors and DNA for the production thereof Claim Types: Composition | JUN 16,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | MAR 25,2007 |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GONAL-F (INJECTABLE) FOLLITROPIN ALFA/BETA
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; PHARMACEUTICAL AIDS
NDA Applicant: SERONO INC NDA No.: 021765 Prod. No.: 001 DISC (37.5 IU/VIAL); 003 DISC (150 IU/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5767251 DS* Recombinant heterodimeric human fertility hormones, and methods, cells, and vectors and DNA for the production thereof Claim Types: Composition | JUN 16,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | MAR 25,2007 |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
HUMATROPE (INJECTABLE) SOMATROPIN RECOMBINANT
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: LILLY NDA No.: 019640 Prod. No.: 004 RX (5MG/VIAL); 005 RX (6MG/VIAL); 006 RX (12MG/VIAL); 007 RX (24MG/VIAL) NDA No.: 019640 Prod. No.: 001 DISC (2MG/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: I - New Indication | JUL 25,2006 | I-398: Idiopathic short stature |
| Exclusivity Code: M - Miscellaneous | OCT 12,2008 | M-45: Information added to clinical trials section of labeling - effects of HUMATROPE treatment in adults with growth hormone deficiency |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
LUPRON DEPOT (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; ANTINEOPLASTICS; ESTROGENS/PROGESTINS
NDA Applicant: TAP PHARM NDA No.: 019732 Prod. No.: 001 RX (7.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process | MAY 01,2006 | |
| Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation | JUL 18,2006 | |
| Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation | SEP 02,2013 | |
| Pat. No. 5631020 Method for producing microcapsule Claim Types: Product-by-process; Process | MAY 20,2014 | |
| Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process | SEP 02,2013 | |
| Pat. No. 6036976 Sustained release microspheres and preparation thereof Claim Types: Product-by-process | DEC 13,2016 |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
LUPRON DEPOT (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; ANTINEOPLASTICS
NDA Applicant: TAP PHARM NDA No.: 020011 Prod. No.: 001 RX (3.75MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process | MAY 01,2006 | |
| Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation | JUL 18,2006 | |
| Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation | SEP 02,2013 | |
| Pat. No. 5631021 Method for producing microcapsule Claim Types: Product-by-process | MAY 20,2014 | |
| Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process | SEP 02,2013 |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
LUPRON DEPOT-3 (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; ANTINEOPLASTICS
NDA Applicant: TAP PHARM NDA No.: 020708 Prod. No.: 001 RX (11.25MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process | MAY 01,2006 | |
| Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation | JUL 18,2006 | |
| Pat. No. 5480656 Prolonged release microcapsules Claim Types: Formulation | JAN 02,2013 | |
| Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation | NOV 19,2013 | |
| Pat. No. 5631020 Method for producing microcapsule Claim Types: Product-by-process; Process | MAY 20,2014 | |
| Pat. No. 5643607 Prolonged release microcapsules Claim Types: Formulation; Process | JAN 02,2013 | |
| Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process | SEP 02,2013 | |
| Pat. No. 5814342 Prolonged release microcapsules Claim Types: Formulation; Process | FEB 01,2011 | |
| Pat. No. 6036976 Sustained release microspheres and preparation thereof Claim Types: Product-by-process | DEC 13,2016 |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NUTROPIN AQ; NUTROPIN AQ PEN (INJECTABLE) SOMATROPIN RECOMBINANT
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: GENENTECH NDA No.: 020522 Prod. No.: 001 RX (5MG/ML); 002 RX (5MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5763394 DP* Human growth hormone aqueous formulation Claim Types: Formulation; Drug in a container; Method of use | JUN 09,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JUN 28,2008 | I-462: Long term treatment of idiopathic short stature |
| Exclusivity Code: M - Miscellaneous | NOV 18,2008 | M-50: New info to the clinical studies, adult growth hormone deficiency (GHD) subsection of the NUTROPIN aq package insert describing the effects of somatropin on visceral adipose tissue in the adult growth hormone deficient patient population |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NUTROPIN (INJECTABLE) SOMATROPIN RECOMBINANT
Drug Classes: DRUGS USED IN DISORDERS OF GROWTH HORMONE SECRETION; ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: GENENTECH NDA No.: 020168 Prod. No.: 001 RX (5MG/VIAL); 002 RX (10MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5096885 DP* Human growth hormone formulation Claim Types: Formulation; Method of administration | MAR 17,2009 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JUN 28,2008 | I-462: Long term treatment of idiopathic short stature |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
SANDOSTATIN LAR (INJECTABLE) OCTREOTIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; PHARMACEUTICAL AIDS
NDA Applicant: NOVARTIS NDA No.: 021008 Prod. No.: 001 RX (EQ 10MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5538739 DP* Sustained release formulations of water soluble peptides Claim Types: Formulation | JAN 23,2014 *PED | |
| Pat. No. 5639480 DP* Sustained release formulations of water soluble peptides Claim Types: Formulation | DEC 17,2014 *PED | |
| Pat. No. 5688530 Sustained release formulations of water soluble peptides Claim Types: Method of use | MAY 18,2015 *PED | U-268: Acromegaly |
| Pat. No. 5922338 DP* Polyol esters, their preparation and use in depot forms of pharmacologically active agents Claim Types: Composition | JAN 13,2017 *PED | |
| Pat. No. 5922682 DP* Polyol esters, their preparation and use in depot forms of pharmacologically active agents Claim Types: Excipient; Formulation | JAN 13,2017 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 10,2009 PED | M-55: Information on results of a study of the use of SANDOSTATIN lar depot in pediatric patients with hypothalamic obesity. |
| Exclusivity Code ODE: Orphan Drug | May 25,2006 PED |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
SANDOSTATIN LAR (INJECTABLE) OCTREOTIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; PHARMACEUTICAL AIDS
NDA Applicant: NOVARTIS NDA No.: 021008 Prod. No.: 002 RX (EQ 20MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5538739 Sustained release formulations of water soluble peptides Claim Types: Formulation | JAN 23,2014 *PED | |
| Pat. No. 5639480 DP* Sustained release formulations of water soluble peptides Claim Types: Formulation | DEC 17,2014 *PED | |
| Pat. No. 5688530 Sustained release formulations of water soluble peptides Claim Types: Method of use | MAY 18,2015 *PED | U-268: Acromegaly |
| Pat. No. 5922338 DP* Polyol esters, their preparation and use in depot forms of pharmacologically active agents Claim Types: Composition | JAN 13,2017 *PED | |
| Pat. No. 5922682 DP* Polyol esters, their preparation and use in depot forms of pharmacologically active agents Claim Types: Excipient; Formulation | JAN 13,2017 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 10,2009 PED | M-55: Information on results of a study of the use of SANDOSTATIN lar depot in pediatric patients with hypothalamic obesity. |
| Exclusivity Code ODE: Orphan Drug | May 25,2006 PED |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
SANDOSTATIN LAR (INJECTABLE) OCTREOTIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; PHARMACEUTICAL AIDS
NDA Applicant: NOVARTIS NDA No.: 021008 Prod. No.: 003 RX (EQ 30MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5538739 Sustained release formulations of water soluble peptides Claim Types: Formulation | JAN 23,2014 *PED | |
| Pat. No. 5639480 DP* Sustained release formulations of water soluble peptides Claim Types: Formulation | DEC 17,2014 *PED | |
| Pat. No. 5688530 Sustained release formulations of water soluble peptides Claim Types: Method of use | MAY 18,2015 *PED | U-268: Acromegaly |
| Pat. No. 5922338 DP* Polyol esters, their preparation and use in depot forms of pharmacologically active agents Claim Types: Composition | JAN 13,2017 *PED | |
| Pat. No. 5922682 DP* Polyol esters, their preparation and use in depot forms of pharmacologically active agents Claim Types: Excipient; Formulation | JAN 13,2017 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 25,2009 PED | M-55: Information on results of a study of the use of SANDOSTATIN lar depot in pediatric patients with hypothalamic obesity. |
| Exclusivity Code ODE: Orphan Drug | May 25,2006 PED |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
ZOLADEX (IMPLANT) GOSERELIN ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: ASTRAZENECA NDA No.: 019726 Prod. No.: 001 RX (EQ 3.6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5366734 Continuous release pharmaceutical compositions Claim Types: Method of administration | NOV 22,2011 |
ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
ZOLADEX (IMPLANT) GOSERELIN ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: ASTRAZENECA NDA No.: 020578 Prod. No.: 001 RX (EQ 10.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5366734 Continuous release pharmaceutical compositions Claim Types: Method of administration | NOV 22,2011 |
ANTHELMINTICS
ALINIA (TABLET) NITAZOXANIDE
Drug Classes: ANTIPROTOZOALS; ANTHELMINTICS
NDA Applicant: ROMARK NDA No.: 021497 Prod. No.: 001 RX (500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5387598 DP* Composition and galenic formulation suitable for combatting affections of the lower abdomen Claim Types: Formulation; Method of use | FEB 07,2012 | U-524: Method of treating diarrhea |
| Pat. No. 5578621 DP* Benzamide derivatives Claim Types: Composition; Method of use; Method of improving a treatment | NOV 26,2013 | U-525: Method of treating parasitic infections |
| Pat. No. 5968961 DP* Pharmaceutical compositions of tizoxanide and nitazoxanide Claim Types: Formulation | MAY 07,2017 | |
| Pat. No. 6020353 DS* DP* 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide Claim Types: Compound; Composition | SEP 18,2014 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JUN 16,2008 | I-460: Treatment of diarrhea caused by cryptosporidium parvum in non-HIV infected patients 12 years of age and older |
| Exclusivity Code: NCE - New chemical entity | NOV 22,2007 | |
| Exclusivity Code: NDF - New dosage form | JUL 21,2007 | |
| Exclusivity Code ODE: Orphan Drug | NOV 22,2009 | Treatment of cryptosporidiosis. |
| Exclusivity Code ODE: Orphan Drug | NOV 22,2009 | Treatment of intestinal giardiasis. |
ANTHELMINTICS
ALINIA (FOR SUSPENSION) NITAZOXANIDE
Drug Classes: ANTIPROTOZOALS; ANTHELMINTICS
NDA Applicant: ROMARK NDA No.: 021498 Prod. No.: 001 RX (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5387598 Composition and galenic formulation suitable for combatting affections of the lower abdomen Claim Types: Formulation; Method of use | FEB 07,2012 | U-524: Method of treating diarrhea |
| Pat. No. 5578621 Benzamide derivatives Claim Types: Composition; Method of use; Method of improving a treatment | SEP 08,2014 | U-525: Method of treating parasitic infections |
| Pat. No. 5965590 Method for treatment of opportunistic infections with pharmaceutical compositions of tizoxanide and nitazoxanide Claim Types: Method of use | JUL 03,2017 | U-523: Method of treating infection by Cryptosporidium Parvum in an immunocompromised mammal |
| Pat. No. 5968961 Pharmaceutical compositions of tizoxanide and nitazoxanide Claim Types: Formulation | MAY 07,2017 | |
| Pat. No. 6020353 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide Claim Types: Compound; Composition | SEP 08,2014 | |
| Pat. No. 6117894 Acid stabilized pharmaceutical compositions of tizoxanide and nitazoxanide Claim Types: Composition; Formulation | MAY 07,2017 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JUN 16,2008 | I-460: Treatment of diarrhea caused by cryptosporidium parvum in non-HIV infected patients 12 years of age and older |
| Exclusivity Code: NCE - New chemical entity | NOV 22,2007 | |
| Exclusivity Code: NPP - New patient population | JUL 21,2007 | |
| Exclusivity Code ODE: Orphan Drug | NOV 22,2009 | Treatment of cryptosporidiosis. |
| Exclusivity Code ODE: Orphan Drug | NOV 22,2009 | Treatment of intestinal giardiasis. |