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Details for Generic Name: amlodipine besylate; hydrochlorothiazide; valsartan

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Amlodipine besylate; hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Lupin Ltd, Par Pharm, Teva Pharms, Torrent Pharms Ltd, and Novartis, and is included in five NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-four patent family members in twenty-nine countries.

There are forty-seven drug master file entries for amlodipine besylate; hydrochlorothiazide; valsartan. Four suppliers are listed for this compound.

Summary for Generic Name: amlodipine besylate; hydrochlorothiazide; valsartan

Tradenames:2
Patents:3
Applicants:5
NDAs:5
Drug Master File Entries: see list47
Suppliers / Packaging: see list17
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

Clinical Trials for: amlodipine besylate; hydrochlorothiazide; valsartan

Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy
Status: Completed Condition: Hypertension; Hypertrophy, Left Ventricular

Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension
Status: Completed Condition: Hypertension

Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension
Status: Completed Condition: Hypertension

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Status: Completed Condition: Hypertension

Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension
Status: Completed Condition: Hypertension

Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients
Status: Completed Condition: Hypertension

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
Lupin Ltd
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL200797-002Jun 3, 2015RXNo<disabled><disabled>
Teva Pharms
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL200435-002Sep 25, 2012RXNo<disabled><disabled>
Teva Pharms
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL200435-004Sep 25, 2012RXNo<disabled><disabled>
Par Pharm
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL201087-003Jun 1, 2015RXNo<disabled><disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-001Apr 30, 2009RXNo8,101,599<disabled>Y<disabled>
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International Patent Family for Ingredient: amlodipine besylate; hydrochlorothiazide; valsartan

Country Document Number Publication Date
Spain2325207Aug 28, 2009
Peru04392004Aug 20, 2004
Canada2486144Nov 27, 2003
Japan5132872Jan 30, 2013
Malaysia138838Jul 31, 2009
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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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