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Last Updated: March 18, 2024

Valsartan - Generic Drug Details


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What are the generic drug sources for valsartan and what is the scope of freedom to operate?

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

There are forty drug master file entries for valsartan. Thirty-two 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
Duk-Woo Park, MDPhase 4
Daewoong Pharmaceutical Co. LTD.Phase 4
CardioVascular Research Foundation, KoreaPhase 4

See all valsartan clinical trials

Generic filers with tentative approvals for VALSARTAN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial80MG; 12.5MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial320MG; 25MGTABLET; ORAL
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
DIOVAN Tablets valsartan 40 mg, 80 mg, 160 mg and 320 mg 021283 1 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
Ohm Labs Inc VALSARTAN valsartan TABLET;ORAL 077492-003 Jun 26, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd VALSARTAN valsartan TABLET;ORAL 205536-004 Mar 12, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ohm Labs Inc VALSARTAN valsartan TABLET;ORAL 077492-001 Jun 26, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd VALSARTAN valsartan TABLET;ORAL 202223-001 Jan 5, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-001 Dec 23, 1996 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-004 Aug 14, 2002 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-003 Jul 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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