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Last Updated: March 19, 2024

DIOVAN Drug Patent Profile


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Which patents cover Diovan, and when can generic versions of Diovan launch?

Diovan is a drug marketed by Novartis and is included in three NDAs.

The generic ingredient in DIOVAN is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Drug patent expirations by year for DIOVAN
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Drug Sales Revenue Trends for DIOVAN

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Recent Clinical Trials for DIOVAN

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

SponsorPhase
ARKAY TherapeuticsPhase 1/Phase 2
Albany Medical CollegePhase 1/Phase 2
LanZhou UniversityN/A

See all DIOVAN clinical trials

Pharmacology for DIOVAN
Paragraph IV (Patent) Challenges for DIOVAN
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 DIOVAN

DIOVAN is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting DIOVAN

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Exclusivity Expiration: ⤷  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
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-001 Dec 23, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-001 Mar 6, 1998 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001 AB RX Yes 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 DIOVAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 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 021283-004 Aug 14, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DIOVAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1948158 C01948158/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SACUBITRIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
1467728 C01467728/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
0443983 C00443983/03 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.