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Last Updated: July 13, 2020

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Candesartan cilexetil; hydrochlorothiazide - Generic Drug Details

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

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

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

Summary for candesartan cilexetil; hydrochlorothiazide
Recent Clinical Trials for candesartan cilexetil; hydrochlorothiazide

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

SponsorPhase
GlaxoSmithKlinePhase 1
TakedaPhase 4
TakedaN/A

See all candesartan cilexetil; hydrochlorothiazide clinical trials

Generic filers with tentative approvals for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
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; hydrochlorothiazide
Paragraph IV (Patent) Challenges for CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Tradename Dosage Ingredient NDA Submissiondate
ATACAND HCT TABLET;ORAL candesartan cilexetil; hydrochlorothiazide 021093 2009-03-06
ATACAND HCT TABLET;ORAL candesartan cilexetil; hydrochlorothiazide 021093 2008-06-25

US Patents and Regulatory Information for candesartan cilexetil; hydrochlorothiazide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-003 May 16, 2008 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000 AB RX Yes 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; hydrochlorothiazide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-002 Sep 5, 2000   Start Trial   Start Trial
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-003 May 16, 2008   Start Trial   Start Trial
Ani Pharms Inc ATACAND HCT candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 021093-001 Sep 5, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Express Scripts
Dow
Boehringer Ingelheim
McKesson

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