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Generated: May 24, 2017

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Simvastatin - Generic Drug Details

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

is the generic ingredient in three branded drugs marketed by Lupin, Biocon Limited, Oxford Pharms, Zydus Pharms Usa, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Accord Hlthcare, Synthon Pharms, Sandoz Inc, Merck, Mylan Pharms Inc, Tcg Fluent Pharma, Micro Labs Ltd, Sun Pharm Inds Ltd, Watson Labs, Aurobindo Pharma, Hetero Labs Ltd Iii, and Merck Sharp Dohme, and is included in eighteen NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Simvastatin has eight patent family members in eleven countries.

There are thirty-nine drug master file entries for simvastatin. Sixty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: simvastatin

Drug Master File Entries: see list39
Suppliers / Packagers: see list64
Bulk Api Vendors: see list75
Clinical Trials: see list146
Patent Applications: see list6,960
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:simvastatin at DailyMed

Pharmacology for Ingredient: simvastatin

Tentative approvals for SIMVASTATIN

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe5MGTABLET; ORAL
► Subscribe► Subscribe80MGTABLET; ORAL
► Subscribe► Subscribe40MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-001Oct 7, 2011DISCNYesNo7,078,381► Subscribe ► Subscribe
TABLET;ORAL019766-004Dec 23, 1991ABRXYesNo► Subscribe► Subscribe
Dr Reddys Labs Inc
TABLET;ORAL077752-005Jan 23, 2008ABRXNoNo► Subscribe► Subscribe
Dr Reddys Labs Inc
TABLET;ORAL077752-002Dec 20, 2006ABRXNoNo► Subscribe► Subscribe
Merck Sharp Dohme
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-001Oct 7, 2011DISCNYesNo7,326,708► SubscribeYY ► Subscribe
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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 verifification 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.

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