AVALIDE Drug Patent Profile
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Which patents cover Avalide, and what generic alternatives are available?
Avalide is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in AVALIDE 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 AVALIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 3 |
| Patent Applications: | 78 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AVALIDE |
| What excipients (inactive ingredients) are in AVALIDE? | AVALIDE excipients list |
| DailyMed Link: | AVALIDE at DailyMed |
Recent Clinical Trials for AVALIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bayer | Phase 3 |
| Roxane Laboratories | N/A |
Pharmacology for AVALIDE
| 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 AVALIDE
Paragraph IV (Patent) Challenges for AVALIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AVALIDE | Tablets | hydrochlorothiazide; irbesartan | 300 mg/25 mg | 020758 | 1 | 2006-06-06 |
| AVALIDE | Tablets | hydrochlorothiazide; irbesartan | 150 mg/12.5 mg and 300 mg/12.5 mg | 020758 | 1 | 2004-11-10 |
US Patents and Regulatory Information for AVALIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-001 | Sep 30, 1997 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-004 | Mar 15, 2005 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-002 | Sep 30, 1997 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-003 | Aug 31, 1998 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for AVALIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-004 | Mar 15, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-002 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-002 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sanofi Aventis Us | AVALIDE | hydrochlorothiazide; irbesartan | TABLET;ORAL | 020758-001 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for AVALIDE
| 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for AVALIDE
See the table below for patents covering AVALIDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | H10279566 | PHARMACEUTICAL COMPOSITION CONTAINING N-SUBSTITUTED HETEROCYCLIC DERIVATIVE | ⤷ Try a Trial |
| Norway | 914528 | ⤷ Try a Trial | |
| South Africa | 9102072 | ⤷ Try a Trial | |
| Norway | 20004743 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AVALIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0443983 | C00443983/03 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
| 0454511 | 10/1999 | Austria | ⤷ Try a Trial | PRODUCT NAME: ''IRBESARTAN'' ZUSAMMEN MIT ''HYDROCHLOROTHIAZID''; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015 |
| 0565634 | 06C0030 | France | ⤷ Try a Trial | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 |
| 0454511 | C990006 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAAT, EN HYDROCHLOORTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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