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Profile for Tradename: ATACAND HCT

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Atacand Hct is a drug marketed by Astrazeneca and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-one patent family members in ten countries.

The generic ingredient in ATACAND HCT is candesartan cilexetil; hydrochlorothiazide. There are twenty-one drug master file entries for this compound. Four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the candesartan cilexetil; hydrochlorothiazide profile page.

Summary for Tradename: ATACAND HCT

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list12
Formulation / Manufacturing:see details

Pharmacology for Tradename: ATACAND HCT

Clinical Trials for: ATACAND HCT

Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Status: Completed Condition: Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus, Type 2; Diabetes Mellitus; Coronary Disease

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

Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg
Status: Completed Condition: Hypertension

Heart Outcomes Prevention Evaluation-3
Status: Active, not recruiting Condition: Cardiovascular Disease; Stroke

Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide
Status: Completed Condition: Essential Hypertension

Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH
Status: Completed Condition: Essential Hypertension; Left Ventricular Hypertrophy

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

Efficacy of Candesartan on Reducing Blood Pressure in Insulin-Resistant, Obese Patients With Hypertension.
Status: Completed Condition: Obesity; Hypertension

Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions
Status: Completed Condition: Atherosclerosis; Cardiovascular Diseases; Hypertension, Renovascular; Renal Artery Obstruction

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-001Sep 5, 2000RXNo5,721,263<disabled>Y<disabled>
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-002Sep 5, 2000RXNo5,721,263<disabled>Y<disabled>
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-003May 16, 2008RXYes5,721,263<disabled>Y<disabled>
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Paragraph IV activity for: ATACAND HCT

Drugname Dosage Strength RLD Submissiondate
candesartan cilexetil and hydrochlorothiazideTablets32 mg/25 mgAtacand HCT3/6/2009
candesartan cilexetil and hydrochlorothiazideTablets16 mg/12.5 mg and 32 mg/12.5 mgAtacand HCT6/25/2008

Non-Orange Book Patents for Tradename: ATACAND HCT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,958,961 Pharmaceutical composition for angiotensin II-mediated diseases<disabled in preview>
6,348,481 Pharmaceutical composition for angiotensin II-mediated diseases<disabled in preview>
6,420,405 Pharmaceutical composition for angiotensin II-mediated diseases<disabled in preview>
6,228,874 Pharmaceutical composition for angiotensin II-mediated diseases<disabled in preview>
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International Patent Family for Tradename: ATACAND HCT

Country Document Number Publication Date
Germany69435022Oct 18, 2007
Germany69435021Oct 18, 2007
Canada2125251Apr 26, 2005
European Patent Office1306088Sep 05, 2007
European Patent Office1844774Aug 20, 2008
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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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