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Last Updated: April 18, 2024

Candesartan cilexetil - Generic Drug Details


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

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

There are twenty-two drug master file entries for candesartan cilexetil. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for candesartan cilexetil

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Recent Clinical Trials for candesartan cilexetil

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SponsorPhase
United States Department of DefensePhase 2
University of California, San FranciscoPhase 2
The George Institute for Global Health, IndiaPhase 2

See all candesartan cilexetil clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial32MG; 25MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial32MG; 12.5MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial16MG; 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
Paragraph IV (Patent) Challenges for CANDESARTAN CILEXETIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ATACAND Tablets candesartan cilexetil 4 mg, 8 mg, 16 mg and 32 mg 020838 1 2006-12-22

US Patents and Regulatory Information for candesartan cilexetil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 209119-001 Jun 20, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 204100-003 Feb 27, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 090704-002 Dec 4, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Lifesciences CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 203466-002 Nov 27, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Lifesciences CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 091390-002 Aug 23, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202965-001 Jun 3, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-001 Jun 4, 1998 AB RX Yes 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 candesartan cilexetil

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