IRBESARTAN - Generic Drug Details
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What are the generic drug sources for irbesartan and what is the scope of freedom to operate?
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-two suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for IRBESARTAN
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 22 |
NDAs: | 22 |
Drug Master File Entries: | 38 |
Finished Product Suppliers / Packagers: | 22 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 125 |
Patent Applications: | 6,902 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for IRBESARTAN |
Drug Sales Revenues: | Drug sales revenues for IRBESARTAN |
What excipients (inactive ingredients) are in IRBESARTAN? | IRBESARTAN excipients list |
DailyMed Link: | IRBESARTAN at DailyMed |
Recent Clinical Trials for IRBESARTAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Iain Bressendorff | Phase 2 |
University of Edinburgh | Phase 2 |
Handok Inc. | Phase 1 |
Generic filers with tentative approvals for IRBESARTAN
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 300MG; 25MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 300MG; 12.5MG | TABLET; ORAL |
⤷ Sign Up | ⤷ Sign Up | 150MG; 12.5MG | TABLET; 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
Drug Class | Angiotensin 2 Receptor Blocker |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Unichem | IRBESARTAN | irbesartan | TABLET;ORAL | 203020-002 | Dec 7, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hisun Pharm Hangzhou | IRBESARTAN | irbesartan | TABLET;ORAL | 206194-003 | Jun 14, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chartwell Rx | IRBESARTAN | irbesartan | TABLET;ORAL | 203161-001 | Sep 27, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hetero Labs Ltd V | IRBESARTAN | irbesartan | TABLET;ORAL | 202910-003 | Sep 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Macleods Pharms Ltd | IRBESARTAN | irbesartan | TABLET;ORAL | 202254-003 | Oct 3, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Watson Labs Inc | IRBESARTAN | irbesartan | TABLET;ORAL | 090720-002 | Oct 12, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sandoz | IRBESARTAN | irbesartan | TABLET;ORAL | 077466-003 | Sep 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-001 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-002 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-001 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-002 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-003 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>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 | |
Pharmathen S.A. | Sabervel | irbesartan | EMEA/H/C/002510 Sabervel is indicated in adults for the treatment of essential hypertension.It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen. |
Withdrawn | yes | no | no | 2012-04-13 | |
Bristol-Myers Squibb Pharma EEIG | Irbesartan BMS | irbesartan | EMEA/H/C/000786 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 (see section 5.1). |
Withdrawn | no | no | no | 2007-01-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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