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Irbesartan - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for irbesartan?

Irbesartan is the generic ingredient in two branded drugs marketed by West-ward Pharms Int, Cipla Ltd, Hetero Labs Ltd V, Zydus Pharms Usa Inc, Unichem Labs Ltd, Watson Labs Inc, Lupin Ltd, Apotex Inc, Jubilant Generics, Alembic Pharms Ltd, Macleods Pharms Ltd, Sanofi Aventis Us, Teva Pharms, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz, Prinston Inc, Sciegen Pharms Inc, Aurobindo Pharma Ltd, Ajanta Pharma Ltd, and Hisun Pharm Hangzhou, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for irbesartan. Twenty-seven suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: irbesartan

Tradenames:2
Patents:1
Applicants:21
NDAs:21
Drug Master File Entries: see list38
Suppliers / Packagers: see list27
Bulk Api Vendors: see list90
Clinical Trials: see list16
Patent Applications: see list4,960
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:irbesartan at DailyMed

Pharmacology for Ingredient: irbesartan

Tentative approvals for IRBESARTAN

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL150MG; 12.5MG
► Subscribe► SubscribeTABLET; ORAL300MG; 12.5MG
► Subscribe► SubscribeTABLET; ORAL300MG; 25MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V
IRBESARTAN
irbesartan
TABLET;ORAL202910-001Sep 27, 2012RXNoNo► Subscribe► Subscribe
Sandoz
IRBESARTAN
irbesartan
TABLET;ORAL077466-002Sep 27, 2012RXNoNo► Subscribe► Subscribe
Ajanta Pharma Ltd
IRBESARTAN
irbesartan
TABLET;ORAL203685-003Dec 10, 2015RXNoNo► Subscribe► Subscribe
Watson Labs Inc
IRBESARTAN
irbesartan
TABLET;ORAL090720-003Oct 12, 2012DISCNNoNo► Subscribe► Subscribe
Unichem Labs Ltd
IRBESARTAN
irbesartan
TABLET;ORAL203020-003Dec 7, 2015RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: irbesartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-001Sep 30, 19975,270,317*PED► Subscribe
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-003Sep 30, 19976,342,247*PED► Subscribe
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-001Sep 30, 19976,342,247*PED► Subscribe
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-003Sep 30, 19975,270,317*PED► Subscribe
Sanofi Aventis Us
AVAPRO
irbesartan
TABLET;ORAL020757-002Sep 30, 19976,342,247*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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