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Last Updated: March 8, 2021

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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 Inc, 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.

Summary for candesartan cilexetil
Drug Prices for candesartan cilexetil

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Recent Clinical Trials for candesartan cilexetil

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

SponsorPhase
Altasciences Company Inc.Phase 1
Pharmtechnology LLCPhase 1
CJ HealthCare CorporationPhase 4

See all candesartan cilexetil clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial32MG; 25MGTABLET; ORAL
  Start Trial  Start Trial32MG; 12.5MGTABLET; ORAL
  Start Trial  Start 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 NDA Submissiondate
ATACAND TABLET;ORAL candesartan cilexetil 020838 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
Mylan CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 090704-002 Dec 4, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202965-003 Jun 3, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202884-002 Dec 4, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex Inc CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 202079-003 Jan 10, 2014 DISCN No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd CANDESARTAN CILEXETIL candesartan cilexetil TABLET;ORAL 210302-002 Dec 4, 2018 AB RX No No   Start Trial   Start Trial   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-004 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-003 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-004 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-002 Jun 4, 1998   Start Trial   Start Trial
Ani Pharms Inc ATACAND candesartan cilexetil TABLET;ORAL 020838-004 Jun 4, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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