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Serving 500+ biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Chubb
US Department of Justice
Queensland Health
QuintilesIMS
Cipla
Accenture
UBS
Moodys

Generated: September 25, 2017

DrugPatentWatch Database Preview

SIMVASTATIN Drug Profile

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Which patents cover Simvastatin, and when can generic versions of Simvastatin launch?

Simvastatin is a drug marketed by Lupin, Biocon Limited, Oxford Pharms, Zydus Pharms Usa, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Accord Hlthcare, Synthon Pharms, Sandoz Inc, Mylan Pharms Inc, Tcg Fluent Pharma, Micro Labs Ltd, Sun Pharm Inds Ltd, Watson Labs Teva, Aurobindo Pharma, and Hetero Labs Ltd Iii. and is included in sixteen NDAs. There is one patent protecting this drug.

This drug has eight patent family members in eleven countries.

The generic ingredient in SIMVASTATIN is simvastatin. There are thirty-nine drug master file entries for this compound. Sixty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the simvastatin profile page.

Summary for Tradename: SIMVASTATIN

Patents:1
Applicants:16
NDAs:16
Suppliers / Packagers: see list63
Bulk Api Vendors: see list75
Clinical Trials: see list444
Patent Applications: see list7,135
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SIMVASTATIN at DailyMed

Pharmacology for Tradename: SIMVASTATIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd Iii
SIMVASTATIN
simvastatin
TABLET;ORAL200895-001Nov 25, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz Inc
SIMVASTATIN
simvastatin
TABLET;ORAL077766-002Dec 20, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Accord Hlthcare
SIMVASTATIN
simvastatin
TABLET;ORAL078155-002Feb 26, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
SIMVASTATIN
simvastatin
TABLET;ORAL090868-005Jun 8, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
SIMVASTATIN
simvastatin
TABLET;ORAL076285-004Dec 20, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
SIMVASTATIN
simvastatin
TABLET;ORAL090868-001Jun 8, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Tcg Fluent Pharma
SIMVASTATIN
simvastatin
SUSPENSION;ORAL206679-001Apr 21, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Micro Labs Ltd
SIMVASTATIN
simvastatin
TABLET;ORAL090383-004Sep 16, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
SIMVASTATIN
simvastatin
TABLET;ORAL076285-005Jun 23, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
SIMVASTATIN
simvastatin
TABLET;ORAL076052-003Jun 23, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
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International Patent Family for Tradename: SIMVASTATIN

Country Document Number Estimated Expiration
Japan2009534459► Subscribe
Cyprus1112917► Subscribe
World Intellectual Property Organization (WIPO)2007125339► Subscribe
Australia2007245410► Subscribe
Portugal2018153► Subscribe
Slovenia2018153► Subscribe
European Patent Office2018153► Subscribe
Denmark2018153► Subscribe
Austria552825► Subscribe
Spain2385752► 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
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
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
/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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Julphar
Argus Health
Citi
Chinese Patent Office
Accenture
Baxter
Teva
QuintilesIMS
Daiichi Sankyo
Fish and Richardson

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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