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Serving 500+ biopharmaceutical companies globally:

Covington
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US Department of Justice
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Generated: June 26, 2017

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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 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.

Simvastatin has eight patent family members in eleven countries.

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

Summary for Generic Name: simvastatin

Tradenames:3
Patents:10
Applicants:18
NDAs:18
Drug Master File Entries: see list39
Suppliers / Packagers: see list62
Bulk Api Vendors: see list75
Clinical Trials: see list444
Patent Applications: see list6,960
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:simvastatin at DailyMed

Pharmacology for Ingredient: simvastatin

Tentative approvals for SIMVASTATIN

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe5MGTABLET; ORAL
► Subscribe► Subscribe80MGTABLET; ORAL
► Subscribe► Subscribe40MGTABLET; 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;ORAL077691-005Dec 20, 2006ABRXNoNo► Subscribe► Subscribe
Synthon Pharms
SIMVASTATIN
simvastatin
TABLET, ORALLY DISINTEGRATING;ORAL021961-004Oct 9, 2007DISCNNoNo► Subscribe► Subscribe
Mylan Pharms Inc
SIMVASTATIN
simvastatin
TABLET;ORAL090868-001Jun 8, 2010DISCNNoNo► Subscribe► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-003Oct 7, 2011DISCNYesNo6,699,871► SubscribeYY ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-003Oct 7, 2011DISCNYesNo7,125,873► SubscribeY ► 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
Merck
ZOCOR
simvastatin
TABLET;ORAL019766-005Jul 10, 1998RE36481*PED► Subscribe
Merck
ZOCOR
simvastatin
TABLET;ORAL019766-005Jul 10, 1998RE36520*PED► Subscribe
Merck
ZOCOR
simvastatin
TABLET;ORAL019766-002Dec 23, 19914,444,784*PED► Subscribe
Merck
ZOCOR
simvastatin
TABLET;ORAL019766-004Dec 23, 1991RE36481*PED► Subscribe
Merck
ZOCOR
simvastatin
TABLET;ORAL019766-002Dec 23, 1991RE36520*PED► Subscribe
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International Patent Family for Ingredient: simvastatin

Country Document Number Estimated Expiration
Slovenia2018153► Subscribe
China101431982► Subscribe
Austria552825► Subscribe
Portugal2018153► Subscribe
European Patent Office2018153► 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
/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
C0040France► SubscribePRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
McKinsey
US Department of Justice
Cantor Fitzgerald
Fuji
AstraZeneca
Moodys
Healthtrust
Express Scripts
McKesson

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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