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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-four 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 list34
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

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
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-001Jul 18, 2001RXNo6,294,197*PED<disabled>Y<disabled>
Prinston Inc
VALSARTAN
valsartan
TABLET;ORAL204821-003Jun 9, 2015RXNo<disabled><disabled>
Watson Labs Inc
VALSARTAN
valsartan
TABLET;ORAL090642-002Jan 5, 2015RXNo<disabled><disabled>
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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
TABLET;ORAL021283-004Aug 14, 20025,399,578*PED<disabled>
Novartis
DIOVAN
valsartan
CAPSULE;ORAL020665-001Dec 23, 19965,399,578*PED<disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 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>
5,977,160 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims<disabled in preview>
6,485,745 Solid oral dosage forms of valsartan<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
European Patent Office0914119<disabled in preview>
European Patent Office1776953<disabled in preview>
Poland188271<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
07C/043Belgium<disabled>PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
C/GB97/009United Kingdom<disabled>PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016
/1997Austria<disabled>PRODUCT 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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