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Last Updated: August 9, 2020

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Hydrochlorothiazide; valsartan - Generic Drug Details

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

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

There are thirty-two drug master file entries for hydrochlorothiazide; valsartan. Sixteen 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
Tehran University of Medical SciencesPhase 3

See all hydrochlorothiazide; valsartan clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; VALSARTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial25MG;320MGTABLET;ORAL
  Start Trial  Start Trial12.5MG;320MGTABLET;ORAL
  Start Trial  Start 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 NDA Submissiondate
DIOVAN HCT TABLET;ORAL hydrochlorothiazide; valsartan 020818 2007-02-07
DIOVAN HCT TABLET;ORAL hydrochlorothiazide; valsartan 020818 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 078020-001 Sep 21, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-002 Mar 6, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-003 Jan 17, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Lupin Ltd VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078946-003 Mar 21, 2013 AB RX 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 hydrochlorothiazide; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-004 Apr 28, 2006   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-001 Mar 6, 1998   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-002 Mar 6, 1998   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-004 Apr 28, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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