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Last Updated: February 26, 2024

Simvastatin - Generic Drug Details

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

Simvastatin is the generic ingredient in four branded drugs marketed by Tcg Fluent Pharma, 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, Mylan Pharms Inc, 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 five 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-seven 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

United States Department of DefenseEarly Phase 1
National Cancer Institute, NaplesPhase 2
Ahmad ElheenyEarly Phase 1

See all simvastatin clinical trials

Generic filers with tentative approvals for SIMVASTATIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial80MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial40MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial20MGTABLET; 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
Invagen Pharms SIMVASTATIN simvastatin TABLET;ORAL 206557-002 Nov 13, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-001 Oct 7, 2011 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms Usa SIMVASTATIN simvastatin TABLET;ORAL 077837-004 Dec 20, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 019766-005 Jul 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Organon ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 ⤷  Try a Trial ⤷  Try a Trial
Organon ZOCOR simvastatin TABLET;ORAL 019766-001 Dec 23, 1991 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for simvastatin

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

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