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Last Updated: November 2, 2024

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 Salerno Pharms, 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, Norvium Bioscience, 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-six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for SIMVASTATIN

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Drug Sales Revenue Trends for SIMVASTATIN

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Recent Clinical Trials for SIMVASTATIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
International Bio servicePhase 1
State University of New York - Downstate Medical CenterPhase 1/Phase 2
United States Department of DefenseEarly Phase 1

See all SIMVASTATIN clinical trials

Generic filers with tentative approvals for SIMVASTATIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up80MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up40MGTABLET; 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
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
Zydus Pharms Usa SIMVASTATIN simvastatin TABLET;ORAL 077837-001 Dec 20, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma SIMVASTATIN simvastatin TABLET;ORAL 077691-001 Dec 20, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma SIMVASTATIN simvastatin TABLET;ORAL 077691-003 Dec 20, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Inc SIMVASTATIN simvastatin TABLET;ORAL 077752-004 Dec 20, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd Iii SIMVASTATIN simvastatin TABLET;ORAL 200895-004 Nov 25, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Biocon Pharma SIMVASTATIN simvastatin TABLET;ORAL 078034-005 Dec 20, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Invagen Pharms SIMVASTATIN simvastatin TABLET;ORAL 206557-002 Nov 13, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 019766-002 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-004 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-001 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-005 Jul 10, 1998 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-004 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-005 Jul 10, 1998 ⤷  Sign Up ⤷  Sign Up
Organon ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SIMVASTATIN

Country Patent Number Title Estimated Expiration
Japan 2009534459 ⤷  Sign Up
Portugal 2018153 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2007125339 ⤷  Sign Up
Spain 2385752 ⤷  Sign Up
Australia 2007245410 Liquid oral compositions ⤷  Sign Up
European Patent Office 2018153 COMPOSITIONS ORALES LIQUIDES (LIQUID ORAL COMPOSITIONS) ⤷  Sign Up
China 101431982 Liquid oral compositions ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIMVASTATIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 05C0040 France ⤷  Sign Up PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599 26/2005 Austria ⤷  Sign Up 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 SPC/GB05/010 United Kingdom ⤷  Sign Up 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
0720599 122004000026 Germany ⤷  Sign Up 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
0720599 C300172 Netherlands ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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