IRBESARTAN AND HYDROCHLOROTHIAZIDE Drug Patent Profile
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When do Irbesartan And Hydrochlorothiazide patents expire, and when can generic versions of Irbesartan And Hydrochlorothiazide launch?
Irbesartan And Hydrochlorothiazide is a drug marketed by Alembic, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz, Teva, Unichem, and Watson Labs Inc. and is included in fifteen NDAs.
The generic ingredient in IRBESARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for IRBESARTAN AND HYDROCHLOROTHIAZIDE
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 12 |
| Clinical Trials: | 15 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in IRBESARTAN AND HYDROCHLOROTHIAZIDE? | IRBESARTAN AND HYDROCHLOROTHIAZIDE excipients list |
| DailyMed Link: | IRBESARTAN AND HYDROCHLOROTHIAZIDE at DailyMed |
Recent Clinical Trials for IRBESARTAN AND HYDROCHLOROTHIAZIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Damanhour University | N/A |
| Roxane Laboratories | N/A |
| Bristol-Myers Squibb | Phase 4 |
Pharmacology for IRBESARTAN AND HYDROCHLOROTHIAZIDE
| Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for IRBESARTAN AND HYDROCHLOROTHIAZIDE
US Patents and Regulatory Information for IRBESARTAN AND HYDROCHLOROTHIAZIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 077369-003 | Mar 30, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sandoz | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 077446-001 | Sep 27, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Unichem | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 207018-001 | Sep 19, 2017 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sandoz | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 077446-002 | Sep 27, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alembic | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 091370-001 | Oct 15, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hisun Pharm Hangzhou | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 207896-002 | Oct 14, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Pharms Inc | IRBESARTAN AND HYDROCHLOROTHIAZIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 077969-002 | Sep 27, 2012 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 AND HYDROCHLOROTHIAZIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| sanofi-aventis groupe | Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) | irbesartan, hydrochlorothiazide | EMEA/H/C/000783 Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. |
Authorised | no | no | no | 2007-01-18 | |
| Sanofi Winthrop Industrie | Karvezide | irbesartan, hydrochlorothiazide | EMEA/H/C/000221 Treatment of essential hypertension.This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. |
Authorised | no | no | no | 1998-10-16 | |
| Sanofi Winthrop Industrie | CoAprovel | irbesartan, hydrochlorothiazide | EMEA/H/C/000222 Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. |
Authorised | no | no | no | 1998-10-14 | |
| Krka, d.d., Novo mesto | Ifirmacombi | irbesartan, hydrochlorothiazide | EMEA/H/C/002302 Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. |
Authorised | yes | no | no | 2011-03-04 | |
| Teva B.V. | Irbesartan/Hydrochlorothiazide Teva | irbesartan, hydrochlorothiazide | EMEA/H/C/001112 Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. |
Authorised | yes | no | no | 2009-11-26 | |
| Bristol-Myers Squibb Pharma EEIG | Irbesartan Hydrochlorothiazide BMS | irbesartan, hydrochlorothiazide | EMEA/H/C/000784 Treatment of essential hypertension.This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (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 |
