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Valsartan - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for valsartan?

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 two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient 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 list5,102
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; ORAL160MG; 25MG
► Subscribe► SubscribeTABLET; ORAL320MG; 12.5MG
► Subscribe► SubscribeTABLET; ORAL320MG; 25MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
VALSARTAN
valsartan
TABLET;ORAL201677-003Jan 5, 2015RXNoNo► Subscribe► Subscribe
Ivax Pharms
VALSARTAN
valsartan
TABLET;ORAL077530-001Jan 4, 2016RXNoNo► Subscribe► Subscribe
Ohm Labs Inc
VALSARTAN
valsartan
TABLET;ORAL077492-004Jun 26, 2014RXNoNo► Subscribe► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 2002RXYesNo6,294,197*PED► SubscribeY► Subscribe
Torrent Pharms Ltd
VALSARTAN
valsartan
TABLET;ORAL202728-001Jan 5, 2015RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 19965,399,578*PED► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 20015,399,578*PED► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-003Jul 18, 20015,399,578*PED► Subscribe
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-002Dec 23, 19965,399,578*PED► Subscribe
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 20025,399,578*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: valsartan

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,858,228 Solid oral dosage forms of valsartan► Subscribe
5,952,305 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims► Subscribe
6,485,745 Solid oral dosage forms of valsartan► Subscribe
5,977,160 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: valsartan

Country Document Number Estimated Expiration
Germany69739642► Subscribe
Austria276750► Subscribe
Poland188271► Subscribe
New Zealand333385► Subscribe
Portugal1767206► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016017Lithuania► SubscribePRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119
C0039Belgium► SubscribePRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
0443983/02Switzerland► SubscribePRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
0811Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
/1997Austria► SubscribePRODUCT NAME: VALSARTAN ODER EIN PHARMAZEUTISCH VERWENDBARES SALZ ODER EIN ESTER DAVON; NAT. REGISTRATION NO/DATE: 1-21751 UND 1-21752 19961220; FIRST REGISTRATION: DE 36983.00.00 36983.01.00 19960513
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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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