SIMVASTATIN - Generic Drug Details
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What are the generic sources for simvastatin and what is the scope of patent protection?
Simvastatin
is the generic ingredient in four branded drugs marketed by Salerno Pharms, Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Norvium Bioscience, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, Zydus Pharms Usa, Organon, and Merck Sharp Dohme, and is included in nineteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Simvastatin has twelve patent family members in twelve countries.
There are forty drug master file entries for simvastatin. Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for SIMVASTATIN
International Patents: | 12 |
US Patents: | 3 |
Tradenames: | 4 |
Applicants: | 19 |
NDAs: | 19 |
Drug Master File Entries: | 40 |
Finished Product Suppliers / Packagers: | 36 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 583 |
Patent Applications: | 8,116 |
Drug Prices: | Drug price trends for SIMVASTATIN |
Drug Sales Revenues: | Drug sales revenues for SIMVASTATIN |
What excipients (inactive ingredients) are in SIMVASTATIN? | SIMVASTATIN excipients list |
DailyMed Link: | SIMVASTATIN at DailyMed |
Recent Clinical Trials for SIMVASTATIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
International Bio service | Phase 1 |
State University of New York - Downstate Medical Center | Phase 1/Phase 2 |
United States Department of Defense | Early Phase 1 |
Generic filers with tentative approvals for SIMVASTATIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 5MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 80MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 40MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for SIMVASTATIN
Drug Class | HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Medical Subject Heading (MeSH) Categories for SIMVASTATIN
Anatomical Therapeutic Chemical (ATC) Classes for SIMVASTATIN
US Patents and Regulatory Information for SIMVASTATIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Pharms Usa | SIMVASTATIN | simvastatin | TABLET;ORAL | 077837-001 | Dec 20, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | SIMVASTATIN | simvastatin | TABLET;ORAL | 077691-001 | Dec 20, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | SIMVASTATIN | simvastatin | TABLET;ORAL | 077691-003 | Dec 20, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys Labs Inc | SIMVASTATIN | simvastatin | TABLET;ORAL | 077752-004 | Dec 20, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hetero Labs Ltd Iii | SIMVASTATIN | simvastatin | TABLET;ORAL | 200895-004 | Nov 25, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Biocon Pharma | SIMVASTATIN | simvastatin | TABLET;ORAL | 078034-005 | Dec 20, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Invagen Pharms | SIMVASTATIN | simvastatin | TABLET;ORAL | 206557-002 | Nov 13, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SIMVASTATIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-002 | Dec 23, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-004 | Dec 23, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-001 | Dec 23, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-005 | Jul 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-004 | Dec 23, 1991 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-005 | Jul 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-003 | Dec 23, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SIMVASTATIN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2009534459 | ⤷ Sign Up | |
Portugal | 2018153 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2007125339 | ⤷ Sign Up | |
Spain | 2385752 | ⤷ Sign Up | |
Australia | 2007245410 | Liquid oral compositions | ⤷ Sign Up |
European Patent Office | 2018153 | COMPOSITIONS ORALES LIQUIDES (LIQUID ORAL COMPOSITIONS) | ⤷ Sign Up |
China | 101431982 | Liquid oral compositions | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SIMVASTATIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0720599 | 05C0040 | France | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 |
0720599 | 26/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402 |
0720599 | SPC/GB05/010 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411 |
0720599 | 122004000026 | Germany | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402 |
0720599 | C300172 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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