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Generated: June 26, 2017
What are the generic drug sources for simvastatin and what is the scope of simvastatin patent protection?
Simvastatin is the generic ingredient in three branded drugs marketed by Lupin, Biocon Limited, Oxford Pharms, Zydus Pharms Usa, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Accord Hlthcare, Synthon Pharms, Sandoz Inc, Merck, Mylan Pharms Inc, Tcg Fluent Pharma, Micro Labs Ltd, Sun Pharm Inds Ltd, Watson Labs Teva, Aurobindo Pharma, Hetero Labs Ltd Iii, and Merck Sharp Dohme, and is included in eighteen NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 3 |
| Patents: | 10 |
| Applicants: | 18 |
| NDAs: | 18 |
| Drug Master File Entries: see list | 39 |
| Suppliers / Packagers: see list | 62 |
| Bulk Api Vendors: see list | 75 |
| Clinical Trials: see list | 444 |
| Patent Applications: see list | 6,960 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | simvastatin at DailyMed |
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 5MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 80MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 40MG | TABLET; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma | SIMVASTATIN | simvastatin | TABLET;ORAL | 077691-005 | Dec 20, 2006 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Synthon Pharms | SIMVASTATIN | simvastatin | TABLET, ORALLY DISINTEGRATING;ORAL | 021961-004 | Oct 9, 2007 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Mylan Pharms Inc | SIMVASTATIN | simvastatin | TABLET;ORAL | 090868-001 | Jun 8, 2010 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-003 | Oct 7, 2011 | DISCN | Yes | No | 6,699,871 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Merck Sharp Dohme | JUVISYNC | simvastatin; sitagliptin phosphate | TABLET;ORAL | 202343-003 | Oct 7, 2011 | DISCN | Yes | No | 7,125,873 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck | ZOCOR | simvastatin | TABLET;ORAL | 019766-005 | Jul 10, 1998 | RE36481*PED | ► Subscribe | ||||||||||||||||||||||
Merck | ZOCOR | simvastatin | TABLET;ORAL | 019766-005 | Jul 10, 1998 | RE36520*PED | ► Subscribe | ||||||||||||||||||||||
Merck | ZOCOR | simvastatin | TABLET;ORAL | 019766-002 | Dec 23, 1991 | 4,444,784*PED | ► Subscribe | ||||||||||||||||||||||
Merck | ZOCOR | simvastatin | TABLET;ORAL | 019766-004 | Dec 23, 1991 | RE36481*PED | ► Subscribe | ||||||||||||||||||||||
Merck | ZOCOR | simvastatin | TABLET;ORAL | 019766-002 | Dec 23, 1991 | RE36520*PED | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Slovenia | 2018153 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101431982 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 552825 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 2018153 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2018153 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| /2005 | Austria | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C/GB05/010 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 00172 | Netherlands | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C0040 | France | ► Subscribe | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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