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Last Updated: March 29, 2024

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.

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
>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 020758-001 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-003 Aug 31, 1998 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-004 Mar 15, 2005 ⤷  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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for AVALIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 24/1998 Austria ⤷  Try a Trial PRODUCT NAME: ''IRBESARTAN'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE; NAT. REGISTRATION NO/DATE: EU/1/97/046/001 - EU/1/97/046/009 19970827; FIRST REGISTRATION: LI 5425002 19970815
0454511 98C0028 Belgium ⤷  Try a Trial PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.