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Details for Generic Name: valsartan

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Valsartan is the generic ingredient in two branded drugs marketed by Novartis, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Mylan Labs Ltd, Ohm Labs Inc, Prinston Inc, Torrent Pharms Ltd, and Watson Labs Inc, and is included in thirteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for valsartan. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: valsartan

Tradenames:2
Patents:2
Applicants:12
NDAs:13
Drug Master File Entries: see list27
Suppliers / Packaging: see list68
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: valsartan

Tentative approvals for VALSARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL160MG; 12.5MG
<disabled><disabled>TABLET; ORAL160MG; 25MG
<disabled><disabled>TABLET; ORAL320MG; 12.5MG

Clinical Trials for: valsartan

Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension
Status: Recruiting Condition: Hypertension

Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM
Status: Recruiting Condition: Hypertrophic Cardiomyopathy

To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
Status: Completed Condition: Hypertension; High Blood Pressure

Valsartan in Cardiovascular Disease With Renal Dysfunction (The V-CARD) Study
Status: Active, not recruiting Condition: Hypertension

Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers
Status: Completed Condition: Hypertension, Hyperlipidemia

Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
Status: Completed Condition: Essential 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
Watson Labs Inc
VALSARTAN
valsartan
TABLET;ORAL090642-002Jan 5, 2015RXNo<disabled><disabled>
Prinston Inc
VALSARTAN
valsartan
TABLET;ORAL204821-001Jun 9, 2015RXNo<disabled><disabled>
Mylan Labs Ltd
VALSARTAN
valsartan
TABLET;ORAL090866-003Jan 5, 2015RXNo<disabled><disabled>
Prinston Inc
VALSARTAN
valsartan
TABLET;ORAL204821-003Jun 9, 2015RXNo<disabled><disabled>
Novartis
DIOVAN
valsartan
TABLET;ORAL021283-002Jul 18, 2001RXNo5,972,990*PED<disabled>Y<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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