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Generated: May 23, 2017

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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 Dr Reddys Labs Ltd, Apotex Inc, Macleods Pharms Ltd, Lupin Ltd, Aurobindo Pharma Ltd, Atlas Pharms Llc, Watson Labs Inc, Sandoz, West-ward Pharms Int, Sanofi Aventis Us, Mylan Pharms Inc, Teva, Alembic Pharms Ltd, Prinston Inc, and Hisun Pharm Hangzhou, and is included in fifteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: hydrochlorothiazide; irbesartan

Drug Master File Entries: see list31
Suppliers / Packagers: see list18
Bulk Api Vendors: see list1
Clinical Trials: see list90
Patent Applications: see list13
Drug Prices:see low prices
DailyMed Link:hydrochlorothiazide; irbesartan at DailyMed

Pharmacology for Ingredient: hydrochlorothiazide; irbesartan


Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe12.5MG;150MGTABLET;ORAL
► Subscribe► Subscribe12.5MG;300MGTABLET;ORAL
► Subscribe► Subscribe25MG;300MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd
hydrochlorothiazide; irbesartan
TABLET;ORAL203630-003Mar 31, 2016ABRXNoNo► Subscribe► Subscribe
Prinston Inc
hydrochlorothiazide; irbesartan
TABLET;ORAL203072-002May 9, 2014ABRXNoNo► Subscribe► Subscribe
Apotex Inc
hydrochlorothiazide; irbesartan
TABLET;ORAL201505-001Oct 15, 2012ABRXNoNo► Subscribe► Subscribe
West-ward Pharms Int
hydrochlorothiazide; irbesartan
TABLET;ORAL090351-001Oct 15, 2012ABRXNoNo► Subscribe► Subscribe
Atlas Pharms Llc
hydrochlorothiazide; irbesartan
TABLET;ORAL203036-003Jan 15, 2016ABRXNoNo► Subscribe► Subscribe
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