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Last Updated: March 2, 2021

DrugPatentWatch Database Preview

Valsartan - Generic Drug Details

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

Valsartan is the generic ingredient in three branded drugs marketed by Novartis, Carmel Biosciences, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Square Pharms Ltd, Torrent, Unichem, and Watson Labs Inc, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for valsartan. Twenty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for valsartan

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Drug Sales Revenue Trends for valsartan

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Recent Clinical Trials for valsartan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yale UniversityPhase 4
Amir SafwatPhase 4
Hospital Geral Roberto SantosPhase 2

See all valsartan clinical trials

Generic filers with tentative approvals for VALSARTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MG; 12.5MGTABLET; ORAL
  Start Trial  Start Trial320MG; 25MGTABLET; ORAL
  Start Trial  Start Trial320MG; 12.5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for valsartan
Medical Subject Heading (MeSH) Categories for valsartan
Paragraph IV (Patent) Challenges for VALSARTAN
Tradename Dosage Ingredient NDA Submissiondate
DIOVAN TABLET;ORAL valsartan 021283 2004-12-28

US Patents and Regulatory Information for valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V VALSARTAN valsartan TABLET;ORAL 203311-002 Jan 5, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Ivax Pharms VALSARTAN valsartan TABLET;ORAL 077530-003 Jan 4, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent VALSARTAN valsartan TABLET;ORAL 202728-002 Jan 5, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001   Start Trial   Start Trial
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-001 Dec 23, 1996   Start Trial   Start Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-004 Aug 14, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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