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Hydrochlorothiazide; irbesartan - Generic Drug Details

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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, Intl Speclt Chems, 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. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: hydrochlorothiazide; irbesartan

Tradenames:2
Patents:0
Applicants:15
NDAs:15
Drug Master File Entries: see list31
Suppliers / Packagers: see list19
Bulk Api Vendors: see list1
Clinical Trials: see list90
Patent Applications: see list9
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:hydrochlorothiazide; irbesartan at DailyMed

Pharmacology for Ingredient: hydrochlorothiazide; irbesartan

Tentative approvals for HYDROCHLOROTHIAZIDE; IRBESARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL25MG;300MG
<disabled><disabled>TABLET; ORAL12.5MG; 150MG
<disabled><disabled>TABLET; ORAL12.5MG; 300MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL091370-002Oct 15, 2012RXNoNo► subscribe► subscribe
Apotex Inc
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL201505-002Oct 15, 2012RXNoNo► subscribe► subscribe
Prinston Inc
IRBESARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL203072-002May 9, 2014RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: hydrochlorothiazide; irbesartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-001Sep 30, 19975,270,317*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-002Sep 30, 19975,994,348*PED► subscribe
Sanofi Aventis Us
AVALIDE
hydrochlorothiazide; irbesartan
TABLET;ORAL020758-003Aug 31, 19985,270,317*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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