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Last Updated: November 21, 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-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

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 Up40MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up20MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up10MGTABLET; 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
Accord Hlthcare SIMVASTATIN simvastatin TABLET;ORAL 078155-002 Feb 26, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs Teva SIMVASTATIN simvastatin TABLET;ORAL 076685-004 Dec 20, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ivax Sub Teva Pharms SIMVASTATIN simvastatin TABLET;ORAL 076052-001 Jun 23, 2006 DISCN 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 019766-005 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 019766-001 Dec 23, 1991 ⤷  Sign Up ⤷  Sign Up
>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 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 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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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 verification 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.