Irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cipla Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Roxane, Sandoz, Teva Pharms, Watson Labs Inc, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
There are thirty-seven drug master file entries for irbesartan. Seven suppliers are listed for this compound. There are five tentative approvals for this compound.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|TABLET;ORAL||201531||Oct 15, 2012||RX||No||<disabled>||<disabled>|
Sanofi Aventis Us
|TABLET;ORAL||020757||Sep 30, 1997||RX||No||6,342,247*PED||<disabled>||Y||<disabled>|
|TABLET;ORAL||090201||Oct 15, 2012||RX||No||<disabled>||<disabled>|
Aurobindo Pharma Ltd
|TABLET;ORAL||203081||Sep 27, 2012||RX||No||<disabled>||<disabled>|
|TABLET;ORAL||203071||Sep 27, 2012||RX||No||<disabled>||<disabled>|
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