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 Tcg Fluent Pharma, 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, Mylan Pharms Inc, 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-seven 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: | 37 |
Raw Ingredient (Bulk) Api Vendors: | 113 |
Clinical Trials: | 580 |
Patent Applications: | 8,116 |
Formulation / Manufacturing: | see details |
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 |
---|---|
United States Department of Defense | Early Phase 1 |
National Cancer Institute, Naples | Phase 2 |
Ahmad Elheeny | Early Phase 1 |
Generic filers with tentative approvals for SIMVASTATIN
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 80MG | TABLET; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 40MG | TABLET; ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 20MG | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys Labs Inc | SIMVASTATIN | simvastatin | TABLET;ORAL | 077752-001 | Dec 20, 2006 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zydus Pharms Usa | SIMVASTATIN | simvastatin | TABLET;ORAL | 077837-005 | Dec 20, 2006 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Chartwell Rx | SIMVASTATIN | simvastatin | TABLET;ORAL | 077766-003 | Dec 20, 2006 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 | 019766-004 | Dec 23, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-001 | Dec 23, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | ZOCOR | simvastatin | TABLET;ORAL | 019766-004 | Dec 23, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for simvastatin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2018153 | COMPOSITIONS ORALES LIQUIDES (LIQUID ORAL COMPOSITIONS) | ⤷ Try a Trial |
China | 101431982 | Liquid oral compositions | ⤷ Try a Trial |
Australia | 2007245410 | Liquid oral compositions | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for simvastatin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0720599 | 26/2005 | Austria | ⤷ Try a Trial | 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 | 05C0040 | France | ⤷ Try a Trial | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 |
0720599 | 122004000026 | Germany | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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