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Valsartan - Generic Drug Details

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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 Labs Ltd, Alembic Pharms Ltd, Lupin Ltd, and Ohm Labs Inc, and is included in fourteen 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-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: valsartan

Tradenames:2
Patents:2
Applicants:13
NDAs:14
Drug Master File Entries: see list29
Suppliers / Packaging: see list35
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: valsartan

Tentative approvals for VALSARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL160MG; 25MG
<disabled><disabled>TABLET; ORAL320MG; 12.5MG
<disabled><disabled>TABLET; ORAL320MG; 25MG

Clinical Trials for: valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
VALSARTAN
valsartan
TABLET;ORAL204011-002Jan 11, 2016RXNo
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 1996DISCNNo
Hetero Labs Ltd V
VALSARTAN
valsartan
TABLET;ORAL203311-003Jan 5, 2015RXNo
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Expired Orange Book Patents for Generic Ingredient: valsartan

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 19965,399,578*PED<disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-004Aug 14, 20025,399,578*PED<disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-003Jul 18, 20015,399,578*PED<disabled>
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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<disabled in preview>
5,952,305 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims<disabled in preview>
5,977,160 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims<disabled in preview>
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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
Russian Federation2009115778<disabled in preview>
Cyprus2553<disabled in preview>
Brazil9709956<disabled in preview>
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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
00445Netherlands<disabled>PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0443983/03Switzerland<disabled>PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
07C/043Belgium<disabled>PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
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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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