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Last Updated: March 31, 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. Eight 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
Synonyms for candesartan cilexetil; hydrochlorothiazide
1145777-98-5
ATACAND HCT
Blopress Plus
C33H34N6O6.C7H8ClN3O4S2
Candesartan cilexetil / hydrochlorothiazide
Candesartan cilexetil mixture with hydrochlorothiazide
Cartex-H
Hydrochlorothiazide mixture with Candesartan cilexetil
Hytacand
LS-178477
Ratacand Plus
SCHEMBL2526670
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
Apotex Inc CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 202884-001 Dec 4, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
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 202965-002 Jun 3, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE candesartan cilexetil; hydrochlorothiazide TABLET;ORAL 090704-003 Dec 4, 2012 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; hydrochlorothiazide

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Express Scripts
Dow
Boehringer Ingelheim
McKesson

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