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Last Updated: April 19, 2024

Candesartan cilexetil - Generic Drug Details


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What are the generic 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
University of California, San FranciscoPhase 2
United States Department of DefensePhase 2
University of SydneyPhase 2

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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
Apotex CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 202079-003 Jan 10, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 204100-002 Feb 27, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-003 May 16, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 206233-003 Aug 21, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202884-001 Dec 4, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 206233-002 Aug 21, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Lifesciences CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 091390-001 Aug 23, 2017 AB RX 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 candesartan cilexetil

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