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Serving leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Merck
Baxter
AstraZeneca
Covington
Farmers Insurance
Deloitte
Harvard Business School
Cantor Fitzgerald

Generated: December 16, 2017

DrugPatentWatch Database Preview

Simvastatin - Generic Drug Details

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What are the generic drug sources for simvastatin and what is the scope of simvastatin patent protection?

Simvastatin
is the generic ingredient in four branded drugs marketed by Tcg Fluent Pharma, Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Limited, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Hisun Pharm Hangzhou, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Oxford Pharms, Sandoz Inc, Sun Pharm Inds Ltd, Viva Hlthcare, Watson Labs Teva, Zydus Pharms Usa, Msd Merck Co, and Merck Sharp Dohme, and is included in nineteen NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Simvastatin has eleven patent family members in eleven countries and four supplementary protection certificates in four countries.

There are thirty-nine drug master file entries for simvastatin. Sixty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for simvastatin

Medical Subject Heading (MeSH) Categories for simvastatin

Tentative approvals for SIMVASTATIN

Applicant Application No. Strength Dosage Form
u► Subscribe5MGTABLET; ORAL
u► Subscribe80MGTABLET; ORAL
u► Subscribe40MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-003Oct 7, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Accord HlthcareSIMVASTATINsimvastatinTABLET;ORAL078155-002Feb 26, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-001Oct 7, 2011DISCNYesNo► Subscribe► SubscribeY► Subscribe
Accord HlthcareSIMVASTATINsimvastatinTABLET;ORAL078155-003Feb 26, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Accord HlthcareSIMVASTATINsimvastatinTABLET;ORAL078155-005Apr 5, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Oxford PharmsSIMVASTATINsimvastatinTABLET;ORAL078735-003Aug 30, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Synthon PharmsSIMVASTATINsimvastatinTABLET, ORALLY DISINTEGRATING;ORAL021961-004Oct 9, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva PharmsSIMVASTATINsimvastatinTABLET;ORAL076052-003Jun 23, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Accord HlthcareSIMVASTATINsimvastatinTABLET;ORAL078155-004Feb 26, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Synthon PharmsSIMVASTATINsimvastatinTABLET, ORALLY DISINTEGRATING;ORAL021961-003Oct 9, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: simvastatin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-003Dec 23, 1991► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-005Jul 10, 1998► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-004Dec 23, 1991► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-001Dec 23, 1991► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-003Dec 23, 1991► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-005Jul 10, 1998► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-003Dec 23, 1991► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-002Dec 23, 1991► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-002Dec 23, 1991► Subscribe► Subscribe
Msd Merck CoZOCORsimvastatinTABLET;ORAL019766-004Dec 23, 1991► Subscribe► Subscribe
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International Patent Family for Ingredient: simvastatin

Country Document Number Estimated Expiration
Cyprus1112917► Subscribe
China101431982► Subscribe
Denmark2018153► Subscribe
Australia2007245410► Subscribe
European Patent Office2018153► Subscribe
Portugal2018153► Subscribe
Austria552825► Subscribe
Japan2009534459► Subscribe
Slovenia2018153► Subscribe
World Intellectual Property Organization (WIPO)2007125339► 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 Certificates for Tradename: SIMVASTATIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0040France► SubscribePRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
/2005Austria► SubscribePRODUCT 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/GB05/010United Kingdom► SubscribePRODUCT 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
00172Netherlands► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

Cerilliant
Chinese Patent Office
Mallinckrodt
Merck
AstraZeneca
Covington
Deloitte
Accenture
Fuji
Citi

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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