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Last Updated: November 22, 2024

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - Generic Drug Details


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What are the generic sources for candesartan cilexetil; hydrochlorothiazide and what is the scope of freedom to operate?

Candesartan cilexetil; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms, Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, and Zydus Lifesciences, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Recent Clinical Trials for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

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

SponsorPhase
GlaxoSmithKlinePhase 1
TakedaPhase 4
Takeda

See all CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up16MG; 12.5MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up32MG; 25MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up32MG; 12.5MGTABLET; 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 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Paragraph IV (Patent) Challenges for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ATACAND HCT Tablets candesartan cilexetil; hydrochlorothiazide 32 mg/25 mg 021093 1 2009-03-06
ATACAND HCT Tablets candesartan cilexetil; hydrochlorothiazide 16 mg/12.5 mg and 32 mg/12.5 mg 021093 1 2008-06-25

US Patents and Regulatory Information for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 204100-002 Feb 27, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 207455-002 Apr 11, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 207455-003 Apr 11, 2018 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

Expired US Patents for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-003 May 16, 2008 ⤷  Sign Up ⤷  Sign Up
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000 ⤷  Sign Up ⤷  Sign Up
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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