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Generated: January 24, 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 hydrochlorothiazide; irbesartan 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. Nineteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for hydrochlorothiazide; irbesartan
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
Tentative approvals for HYDROCHLOROTHIAZIDE; IRBESARTAN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up12.5MG;300MGTABLET;ORAL
➤ Sign Up➤ Sign Up12.5MG;150MGTABLET;ORAL
➤ Sign Up➤ Sign Up25MG;300MGTABLET; ORAL

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
Mylan Pharms Inc IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 077969-002 Sep 27, 2012 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 090351-002 Oct 15, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 201524-002 Feb 27, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Colorcon
Medtronic
Boehringer Ingelheim
Cerilliant
US Army
Chinese Patent Office
QuintilesIMS
McKesson

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