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Last Updated: November 27, 2022

Candesartan cilexetil - Generic Drug Details


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What are the generic drug sources for candesartan cilexetil and what is the scope of patent protection?

Candesartan cilexetil is the generic ingredient in four branded drugs marketed by Ani Pharms, Alembic Pharms Ltd, Apotex Inc, Macleods Pharms Ltd, Mylan, Zydus Pharms, Dr Reddys Labs Ltd, and Prinston Inc, and is included in fourteen 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
The George Institute for Global Health, IndiaPhase 2
University of SydneyPhase 2
Altasciences Company, Inc.Phase 1

See all candesartan cilexetil clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing32MG; 25MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing32MG; 12.5MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing16MG; 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
Ani Pharms ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-003 May 16, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 210302-003 Dec 4, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Macleods Pharms Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 204100-002 Feb 27, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 203466-002 Nov 27, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998 See Plans and Pricing See Plans and Pricing
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998 See Plans and Pricing See Plans and Pricing
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-002 Jun 4, 1998 See Plans and Pricing See Plans and Pricing
Ani Pharms ATACAND candesartan cilexetil TABLET;ORAL 020838-001 Jun 4, 1998 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.