IRBESARTAN Drug Patent Profile
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Which patents cover Irbesartan, and what generic alternatives are available?
Irbesartan is a drug marketed by 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, Zydus Pharms Usa Inc, Alembic, Atlas Pharms Llc, Dr Reddys Labs Ltd, Norvium Bioscience, and Teva. and is included in thirty-seven NDAs.
The generic ingredient in IRBESARTAN is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
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Summary for IRBESARTAN
| US Patents: | 0 |
| Applicants: | 27 |
| NDAs: | 37 |
| Finished Product Suppliers / Packagers: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 139 |
| Clinical Trials: | 125 |
| Patent Applications: | 4,182 |
| Drug Prices: | Drug price information 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 |
See drug prices for IRBESARTAN
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Atlas Pharms Llc | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 203036-001 | Jan 15, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs Inc | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 091539-001 | Oct 22, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Macleods Pharms Ltd | IRBESARTAN | irbesartan | TABLET;ORAL | 202254-002 | Oct 3, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Ipca Labs Ltd | IRBESARTAN | irbesartan | TABLET;ORAL | 211056-002 | May 22, 2024 | 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 |
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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
