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Last Updated: July 7, 2020

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SIMVASTATIN Drug Profile


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When do Simvastatin patents expire, and what generic alternatives are available?

Simvastatin is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Limited, 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, Yaopharma Co Ltd, and Zydus Pharms Usa. and is included in sixteen NDAs.

The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

US ANDA Litigation and Generic Entry Outlook for Simvastatin

A generic version of SIMVASTATIN was approved as simvastatin by AUROBINDO PHARMA on December 20th, 2006.

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Drug patent expirations by year for SIMVASTATIN
Drug Prices for SIMVASTATIN

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Drug Sales Revenue Trends for SIMVASTATIN

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Recent Clinical Trials for SIMVASTATIN

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SponsorPhase
Assiut UniversityPhase 2
Annika BergquistPhase 3
Maimonides Medical CenterPhase 2

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Pharmacology for SIMVASTATIN
Medical Subject Heading (MeSH) Categories for SIMVASTATIN
Paragraph IV (Patent) Challenges for SIMVASTATIN
Tradename Dosage Ingredient NDA Submissiondate
ZOCOR TABLET;ORAL simvastatin 019766

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
Yaopharma Co Ltd SIMVASTATIN simvastatin TABLET;ORAL 077766-004 Dec 20, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Lupin SIMVASTATIN simvastatin TABLET;ORAL 078103-002 May 11, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Hisun Pharm Hangzhou SIMVASTATIN simvastatin TABLET;ORAL 206557-003 Nov 13, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc SIMVASTATIN simvastatin TABLET;ORAL 090868-001 Jun 8, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd SIMVASTATIN simvastatin TABLET;ORAL 076285-002 Dec 20, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Dow
Harvard Business School
McKesson
Moodys
Medtronic

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