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Simvastatin - Generic Drug Details

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Simvastatin 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, Rosemont Pharms Ltd, 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Tradenames:3
Patents:8
Applicants:18
NDAs:18
Drug Master File Entries: see list39
Suppliers / Packaging: see list64
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: simvastatin

Tentative approvals for SIMVASTATIN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL5MG
<disabled><disabled>TABLET; ORAL10MG
<disabled><disabled>TABLET; ORAL20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-004Sep 18, 2012DISCNNo8,168,637► subscribeY ► subscribe
Hetero Labs Ltd Iii
SIMVASTATIN
simvastatin
TABLET;ORAL200895-002Nov 25, 2014RXNo► subscribe► subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-006Sep 18, 2012DISCNNo7,125,873► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: simvastatin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
ZOCOR
simvastatin
TABLET;ORAL019766-004Dec 23, 1991RE36481*PED► subscribe
Merck
ZOCOR
simvastatin
TABLET;ORAL019766-005Jul 10, 1998RE36520*PED► subscribe
Merck
ZOCOR
simvastatin
TABLET;ORAL019766-001Dec 23, 19914,444,784*PED► 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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