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Details for Generic Name: candesartan cilexetil

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Candesartan cilexetil is the generic ingredient in four branded drugs marketed by Astrazeneca, Apotex Inc, Sandoz, Dr Reddys Labs Ltd, Macleods Pharms Ltd, and Mylan Labs, and is included in eight NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for candesartan cilexetil. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: candesartan cilexetil

Drug Master File Entries: see list21
Suppliers / Packaging: see list22
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: candesartan cilexetil

Tentative approvals for CANDESARTAN CILEXETIL

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL32MG
<disabled><disabled>TABLET; ORAL4MG
<disabled><disabled>TABLET; ORAL8MG

Clinical Trials for: candesartan cilexetil

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-002Sep 5, 2000RXNo5,721,263<disabled>Y<disabled>
candesartan cilexetil
TABLET;ORAL020838-004Jun 4, 1998RXYes<disabled><disabled>
Apotex Inc
candesartan cilexetil
TABLET;ORAL202079-003Jan 10, 2014RXNo<disabled><disabled>
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-003May 16, 2008RXYes5,721,263<disabled>Y<disabled>
candesartan cilexetil
TABLET;ORAL078702-002May 3, 2013RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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