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Last Updated: March 19, 2024

Hydrochlorothiazide; valsartan - Generic Drug Details


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

Hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Novartis, Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Watson Labs Teva, and Zydus Lifesciences, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for hydrochlorothiazide; valsartan

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

SponsorPhase
Farma de Colombia SAPhase 3
Damanhour UniversityN/A
Golestan University of Medical SciencePhase 3

See all hydrochlorothiazide; valsartan clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; VALSARTAN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial25MG;320MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial12.5MG;320MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial25MG;160MGTABLET;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 hydrochlorothiazide; valsartan
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; VALSARTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DIOVAN HCT Tablets hydrochlorothiazide; valsartan 320 mg/12.5 mg and 320 mg/25 mg 020818 1 2007-02-07
DIOVAN HCT Tablets hydrochlorothiazide; valsartan 80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg 020818 1 2005-12-02

US Patents and Regulatory Information for hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078020-005 Sep 21, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078946-001 Mar 21, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Teva VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 091519-003 Mar 21, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 201662-005 Mar 21, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 201662-004 Mar 21, 2013 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 hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-003 Jan 17, 2002 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-001 Mar 6, 1998 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-004 Apr 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-004 Apr 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-003 Jan 17, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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