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Last Updated: December 12, 2019

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Hydrochlorothiazide; irbesartan - Generic Drug Details

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

Hydrochlorothiazide; irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Alembic Pharms Ltd, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz, Teva, Unichem Labs Ltd, Watson Labs Inc, and West-ward Pharms Int, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide; irbesartan. Sixteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for hydrochlorothiazide; irbesartan
Recent Clinical Trials for hydrochlorothiazide; irbesartan

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

SponsorPhase
Damanhour UniversityN/A
Roxane LaboratoriesN/A
Bristol-Myers SquibbPhase 4

See all hydrochlorothiazide; irbesartan clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; IRBESARTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial12.5MG;300MGTABLET;ORAL
  Start Trial  Start Trial12.5MG;150MGTABLET;ORAL
  Start Trial  Start Trial25MG;300MGTABLET; 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; irbesartan
Synonyms for hydrochlorothiazide; irbesartan
2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-, 1,1-dioxide, mixt. with 2-butyl-3-((2'-(1H-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-1,3-diazaspiro(4.4)non-1-en-4-one
448264-66-2
C25H28N6O.C7H8ClN3O4S2
CoAprovel
DTXSID80196314
Hydrochlorothiazide / Irbesartan
Hydrochlorothiazide mixture with Irbesartan
Irbesartan Hydrochlorothiazide BMS
Irbesartan Hydrochlorothiazide Winthrop
Irbesartan-hydrochlorothiazide
Karvezide
LS-178480
SCHEMBL2527626
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; IRBESARTAN
Tradename Dosage Ingredient NDA Submissiondate
AVALIDE TABLET;ORAL hydrochlorothiazide; irbesartan 020758 2006-06-06
AVALIDE TABLET;ORAL hydrochlorothiazide; irbesartan 020758 2004-11-10

US Patents and Regulatory Information for hydrochlorothiazide; irbesartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 091370-002 Oct 15, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 202414-002 Sep 27, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem Labs Ltd IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 207018-001 Sep 19, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-002 Sep 30, 1997 AB RX Yes Yes   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; irbesartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-004 Mar 15, 2005   Start Trial   Start Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-001 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-004 Mar 15, 2005   Start Trial   Start Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-003 Aug 31, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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