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Last Updated: March 28, 2024

Irbesartan - Generic Drug Details


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What are the generic sources for irbesartan and what is the scope of patent protection?

Irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, 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, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for irbesartan

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Drug Sales Revenue Trends for irbesartan

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Recent Clinical Trials for irbesartan

Identify potential brand extensions & 505(b)(2) entrants

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

See all irbesartan clinical trials

Generic filers with tentative approvals for IRBESARTAN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial300MG; 25MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial300MG; 12.5MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial150MG; 12.5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Hikma IRBESARTAN irbesartan TABLET;ORAL 090201-003 Oct 15, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V IRBESARTAN irbesartan TABLET;ORAL 202910-002 Sep 27, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms IRBESARTAN irbesartan TABLET;ORAL 077159-001 Mar 30, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma IRBESARTAN irbesartan TABLET;ORAL 090201-001 Oct 15, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Molecular IRBESARTAN irbesartan TABLET;ORAL 077205-002 Nov 14, 2012 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

Expired US Patents for irbesartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-003 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
Teva B.V. Irbesartan Teva irbesartan EMEA/H/C/001093
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 yes no no 2009-10-30
Krka, d.d., Novo mesto Ifirmasta (previously Irbesartan Krka) irbesartan EMEA/H/C/000962
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 yes no no 2008-12-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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