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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

Tradenames:4
Patents:1
Applicants:6
NDAs:8
Drug Master File Entries: see list21
Suppliers: see list7
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; ORAL16MG
<disabled><disabled>TABLET; ORAL32MG
<disabled><disabled>TABLET; ORAL4MG

Clinical Trials for: candesartan cilexetil

Candesartan Effect in Second Stage Arterial Hypertension
Status: Completed Condition: Stage II Hypertension

Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil
Status: Not yet recruiting Condition: Hypertension

Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
Status: Completed Condition: Hypertension

Pharmacokinetic Interactions of Candesartan Cilexetil and Amlodipine Besylate
Status: Active, not recruiting Condition: Healthy

ARIA (Atacand Renoprotection In NephropAthy Pt.)
Status: Completed Condition: Non-diabetic Nephropathy With Hypertension

Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
Status: Completed Condition: Hypertension

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL202884-002Dec 4, 2012RXNo<disabled><disabled>
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-002Sep 5, 2000RXNo5,721,263<disabled>Y<disabled>
Mylan Labs
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL090704-002Dec 4, 2012RXNo<disabled><disabled>
Macleods Pharms Ltd
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL204100-003Feb 27, 2015RXNo<disabled><disabled>
Macleods Pharms Ltd
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL204100-001Feb 27, 2015RXNo<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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