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, Ipca Labs Ltd, 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-three 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: | 23 |
| NDAs: | 23 |
| Drug Master File Entries: | 38 |
| Finished Product Suppliers / Packagers: | 22 |
| Raw Ingredient (Bulk) Api Vendors: | 139 |
| Clinical Trials: | 125 |
| Patent Applications: | 6,882 |
| 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | IRBESARTAN | irbesartan | TABLET;ORAL | 204740-002 | Apr 17, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Prinston Inc | IRBESARTAN | irbesartan | TABLET;ORAL | 203071-001 | Sep 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Jubilant Generics | IRBESARTAN | irbesartan | TABLET;ORAL | 203534-002 | Feb 23, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms Usa Inc | IRBESARTAN | irbesartan | TABLET;ORAL | 079213-002 | Sep 27, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Prinston Inc | IRBESARTAN | irbesartan | TABLET;ORAL | 203071-002 | 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 | 020757-001 | 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 |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-003 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AVAPRO | irbesartan | TABLET;ORAL | 020757-002 | 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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