You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Valsartan - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for valsartan and what is the scope of patent protection?

Valsartan is the generic ingredient in three branded drugs marketed by Novartis, Carmel Biosciences, Novitium Pharma, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Sciegen Pharms Inc, Square Pharms, Torrent, Unichem, and Watson Labs Inc, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for valsartan. Thirty-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for valsartan

See drug prices for valsartan

Drug Sales Revenue Trends for valsartan

See drug sales revenues for valsartan

Recent Clinical Trials for valsartan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Duk-Woo Park, MDPhase 4
Daewoong Pharmaceutical Co. LTD.Phase 4
CardioVascular Research Foundation, KoreaPhase 4

See all valsartan clinical trials

Generic filers with tentative approvals for VALSARTAN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial320MG; 25MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial320MG; 12.5MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial160MG; 25MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for valsartan
Medical Subject Heading (MeSH) Categories for valsartan
Paragraph IV (Patent) Challenges for VALSARTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DIOVAN Tablets valsartan 40 mg, 80 mg, 160 mg and 320 mg 021283 1 2004-12-28

US Patents and Regulatory Information for valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V VALSARTAN valsartan TABLET;ORAL 203311-001 Jan 5, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys VALSARTAN valsartan TABLET;ORAL 201618-001 Oct 5, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc VALSARTAN valsartan TABLET;ORAL 090642-001 Jan 5, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan VALSARTAN valsartan TABLET;ORAL 090866-003 Jan 5, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys VALSARTAN valsartan TABLET;ORAL 201618-003 Oct 5, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms VALSARTAN valsartan TABLET;ORAL 204011-003 Jan 11, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN valsartan TABLET;ORAL 021283-003 Jul 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-001 Dec 23, 1996 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-002 Jul 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-003 Jul 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-002 Jul 18, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.