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Generated: December 14, 2017

DrugPatentWatch Database Preview

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-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 hydrochlorothiazide; irbesartan

Pharmacology for hydrochlorothiazide; irbesartan

Tentative approvals for HYDROCHLOROTHIAZIDE; IRBESARTAN

Applicant Application No. Strength Dosage Form
u► Subscribe12.5MG;150MGTABLET;ORAL
u► Subscribe12.5MG;300MGTABLET;ORAL
u► Subscribe25MG;300MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Atlas Pharms LlcIRBESARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; irbesartanTABLET;ORAL203036-003Jan 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdIRBESARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; irbesartanTABLET;ORAL203500-002Sep 27, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hisun Pharm HangzhouIRBESARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; irbesartanTABLET;ORAL207896-001Oct 14, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Unichem Labs LtdIRBESARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; irbesartanTABLET;ORAL207018-002Sep 19, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdIRBESARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; irbesartanTABLET;ORAL203630-001Feb 22, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Unichem Labs LtdIRBESARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; irbesartanTABLET;ORAL207018-001Sep 19, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Lupin LtdIRBESARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; irbesartanTABLET;ORAL201524-001Feb 27, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson Labs IncIRBESARTAN AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; irbesartanTABLET;ORAL091539-001Oct 22, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-003Aug 31, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-004Mar 15, 2005DISCNYesNo► Subscribe► Subscribe► 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 UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-004Mar 15, 2005► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-001Sep 30, 1997► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-004Mar 15, 2005► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-003Aug 31, 1998► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-002Sep 30, 1997► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-003Aug 31, 1998► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-002Sep 30, 1997► Subscribe► Subscribe
Sanofi Aventis UsAVALIDEhydrochlorothiazide; irbesartanTABLET;ORAL020758-001Sep 30, 1997► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Accenture
Mallinckrodt
Fuji
Dow
QuintilesIMS
Moodys
Julphar
Harvard Business School
Teva
Merck

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