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Last Updated: July 12, 2020

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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, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Neopharma, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem Labs Ltd, 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-four 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

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SponsorPhase
The George InstitutePhase 4
Laboratorio Elea S.A.C.I.F. y A.Phase 2
Alnylam PharmaceuticalsPhase 1

See all irbesartan clinical trials

Generic filers with tentative approvals for IRBESARTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MG; 25MGTABLET; ORAL
  Start Trial  Start Trial300MG; 12.5MGTABLET; ORAL
  Start Trial  Start 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 NDA Submissiondate
AVAPRO TABLET;ORAL irbesartan 020757 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
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Lupin Ltd IRBESARTAN irbesartan TABLET;ORAL 201531-003 Oct 15, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd IRBESARTAN irbesartan TABLET;ORAL 202254-001 Oct 3, 2012 AB RX No No   Start Trial   Start Trial   Start 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 020757-003 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997   Start Trial   Start Trial
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
McKesson
Boehringer Ingelheim
Mallinckrodt
Colorcon

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