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Last Updated: December 1, 2022

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, Hisun Pharm Hangzhou, 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 six 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-four 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
Medical University of South CarolinaPhase 2
Assiut UniversityN/A
University of CincinnatiPhase 1/Phase 2

See all simvastatin clinical trials

Generic filers with tentative approvals for SIMVASTATIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing80MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing40MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing20MGTABLET; 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
Sun Pharm Inds Ltd SIMVASTATIN simvastatin TABLET;ORAL 076285-004 Dec 20, 2006 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii SIMVASTATIN simvastatin TABLET;ORAL 200895-003 Nov 25, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Oxford Pharms SIMVASTATIN simvastatin TABLET;ORAL 078735-001 Aug 30, 2010 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 019766-004 Dec 23, 1991 See Plans and Pricing See Plans and Pricing
Organon ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 See Plans and Pricing See Plans and Pricing
Organon ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing 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 05C0040 France See Plans and Pricing PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599 122004000026 Germany See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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