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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, Jubilant Generics, Lupin Ltd, Mylan Labs Ltd, Ohm Labs Inc, Prinston Inc, Torrent Pharms Ltd, and Watson Labs Inc, and is included in twelve 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-eight drug master file entries for valsartan. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: valsartan

Drug Master File Entries: see list28
Suppliers / Packaging: see list59
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: valsartan

Tentative approvals for VALSARTAN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL320MG; 25MG
<disabled><disabled>TABLET; ORAL80MG; 12.5MG
<disabled><disabled>TABLET; ORAL160MG; 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

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

Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
Status: Completed Condition: Diabetes Mellitus, Type 2

Courtesy of
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
Ohm Labs Inc
TABLET;ORAL077492-002Jun 26, 2014RXNo<disabled><disabled>
Aurobindo Pharma Ltd
TABLET;ORAL202223-002Jan 5, 2015RXNo<disabled><disabled>
Alembic Pharms Ltd
TABLET;ORAL091367-004Jan 5, 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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