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Last Updated: March 2, 2021

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DIOVAN Drug 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. Eighteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Drug patent expirations by year for DIOVAN
Drug Prices 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
Albany Medical CollegePhase 1/Phase 2
ARKAY TherapeuticsPhase 1/Phase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 4

See all DIOVAN clinical trials

Pharmacology for DIOVAN
Paragraph IV (Patent) Challenges for DIOVAN
Tradename Dosage Ingredient NDA Submissiondate
DIOVAN TABLET;ORAL valsartan 021283 2004-12-28

US Patents and Regulatory Information for DIOVAN

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   Start Trial   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-001 Mar 6, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-001 Jul 18, 2001 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-002 Mar 6, 1998 AB RX Yes No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-001 Dec 23, 1996   Start Trial   Start Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-004 Aug 14, 2002   Start Trial   Start Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-003 Jul 18, 2001   Start Trial   Start 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 122016000038 Germany   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728 340 5007-2016 Slovakia   Start Trial PRODUCT NAME: SAKUBITRIL/VALSARTAN, VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1467728 19/2016 Austria   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1467728 132016000051059 Italy   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUSI LORO SALI FARMACEUTICAMENTE ACCETTABILI(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058 - C(2015)8288, 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Medtronic
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