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Last Updated: March 18, 2024

IRBESARTAN Drug Patent Profile


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Which patents cover Irbesartan, and what generic alternatives are available?

Irbesartan is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem, Upsher Smith Labs, Watson Labs Inc, Zydus Pharms Usa Inc, Alembic, Atlas Pharms Llc, Dr Reddys Labs Ltd, Mylan Pharms Inc, and Teva. and is included in thirty-six NDAs.

The generic ingredient in IRBESARTAN is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Drug patent expirations by year for IRBESARTAN
Drug Prices for IRBESARTAN

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Drug Sales Revenue Trends for IRBESARTAN

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Recent Clinical Trials for IRBESARTAN

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SponsorPhase
Iain BressendorffPhase 2
University of EdinburghPhase 2
Handok Inc.Phase 1

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Pharmacology for IRBESARTAN
Paragraph IV (Patent) Challenges for IRBESARTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AVAPRO Tablets irbesartan 75 mg, 150 mg and 300 mg 020757 1 2004-05-25

US Patents and Regulatory Information for IRBESARTAN

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 IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 203630-001 Feb 22, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc IRBESARTAN irbesartan TABLET;ORAL 203071-002 Sep 27, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Generics IRBESARTAN irbesartan TABLET;ORAL 203534-002 Feb 23, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for IRBESARTAN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Sanofi Winthrop Industrie Karvea irbesartan EMEA/H/C/000142
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Authorised no no no 1997-08-26
Sanofi Winthrop Industrie Aprovel irbesartan EMEA/H/C/000141
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.
Authorised no no no 1997-08-26
Zentiva k.s. Irbesartan Zentiva (previously Irbesartan Winthrop) irbesartan EMEA/H/C/000785
Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.
Authorised no no no 2007-01-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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