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Last Updated: November 29, 2022

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 Pharms Ltd, 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. Twenty-four 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

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SponsorPhase
Instituto Nacional de Cardiologia Ignacio ChavezPhase 2/Phase 3
Boehringer Ingelheim laboratoryPhase 2/Phase 3
Medical Research AgencyPhase 4

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Generic filers with tentative approvals for VALSARTAN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing320MG; 25MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing320MG; 12.5MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing160MG; 25MGTABLET; 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
Macleods Pharms Ltd VALSARTAN valsartan TABLET;ORAL 202696-001 Sep 16, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Square Pharms VALSARTAN valsartan TABLET;ORAL 205347-002 Apr 9, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sciegen Pharms Inc VALSARTAN valsartan TABLET;ORAL 204038-002 Oct 27, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021283-002 Jul 18, 2001 See Plans and Pricing See Plans and Pricing
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001 See Plans and Pricing See Plans and Pricing
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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