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Last Updated: March 19, 2024

Hydrochlorothiazide; irbesartan - Generic Drug Details


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What are the generic drug sources for hydrochlorothiazide; irbesartan and what is the scope of patent protection?

Hydrochlorothiazide; irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, 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 sixteen NDAs. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for hydrochlorothiazide; irbesartan
Recent Clinical Trials for hydrochlorothiazide; irbesartan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Damanhour UniversityN/A
Roxane LaboratoriesN/A
SanofiPhase 4

See all hydrochlorothiazide; irbesartan clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; IRBESARTAN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial12.5MG;300MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial12.5MG;150MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial25MG;300MGTABLET; ORAL

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 hydrochlorothiazide; irbesartan
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; IRBESARTAN
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 hydrochlorothiazide; irbesartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs Inc IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 091539-002 Oct 22, 2012 DISCN 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
Atlas Pharms Llc IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 203036-001 Jan 15, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc IRBESARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; irbesartan TABLET;ORAL 201505-002 Oct 15, 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

Expired US Patents for hydrochlorothiazide; irbesartan

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 020758-001 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 020758-003 Aug 31, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for hydrochlorothiazide; irbesartan

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

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