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Last Updated: April 13, 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
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
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
Macleods Pharms Ltd CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 203813-004 Dec 5, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 210302-002 Dec 4, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 203813-003 Dec 5, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 078702-003 May 3, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Lifesciences CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 091390-004 Aug 23, 2017 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
>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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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.