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Generated: April 29, 2017

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Valsartan - Generic Drug Details

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

Valsartan
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Hetero Labs Ltd V, Prinston Inc, Aurobindo Pharma Ltd, Torrent Pharms Ltd, Ivax Pharms, Jubilant Generics, Watson Labs Inc, Novartis, Mylan Pharms Inc, Alembic Pharms Ltd, Lupin Ltd, Ohm Labs Inc, and Macleods Pharms Ltd, and is included in fifteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Valsartan has eighty-eight patent family members in thirty-three countries.

There are twenty-nine drug master file entries for valsartan. Thirty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: valsartan

Tradenames:2
Patents:3
Applicants:14
NDAs:15
Drug Master File Entries: see list29
Suppliers / Packagers: see list39
Bulk Api Vendors: see list84
Clinical Trials: see list67
Patent Applications: see list5,144
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:valsartan at DailyMed

Pharmacology for Ingredient: valsartan

Tentative approvals for VALSARTAN

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL80MG; 12.5MG
► Subscribe► SubscribeTABLET; ORAL160MG; 12.5MG
► Subscribe► SubscribeTABLET; ORAL160MG; 25MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
VALSARTAN
valsartan
TABLET;ORAL204011-003Jan 11, 2016ABRXNoNo► Subscribe► Subscribe
Hetero Labs Ltd V
VALSARTAN
valsartan
TABLET;ORAL203311-001Jan 5, 2015ABRXNoNo► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001ABRXYesNo6,294,197*PED► SubscribeY► Subscribe
Aurobindo Pharma Ltd
VALSARTAN
valsartan
TABLET;ORAL202223-003Jan 5, 2015ABRXNoNo► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002ABRXYesNo6,294,197*PED► SubscribeY► Subscribe
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Paragraph IV Activity

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Non-Orange Book Patents

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International Patents

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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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