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Last Updated: March 28, 2024

diovan Drug Patent Profile


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When do Diovan patents expire, and what generic alternatives are available?

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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Recent Clinical Trials for diovan

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

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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
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-002 Mar 6, 1998 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan CAPSULE;ORAL 020665-002 Dec 23, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-004 Aug 14, 2002 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN valsartan TABLET;ORAL 021283-003 Jul 18, 2001 AB RX Yes Yes ⤷  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 021283-003 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
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

International Patents for diovan

See the table below for patents covering diovan around the world.

Country Patent Number Title Estimated Expiration
Colombia 4870755 FORMAS SOLIDAS DE DOSIFICACION ORAL, PROCEDIMIENTO PARA FA- BRICARLAS, "COPRIMATES", GRANULADOS. ⤷  Try a Trial
Australia 3340297 ⤷  Try a Trial
Hungary T61271 ⤷  Try a Trial
Argentina 059324 UNA FORMA SOLIDA DE DOSIFICACION ORAL ⤷  Try a Trial
European Patent Office 1767207 ⤷  Try a Trial
Ireland 910548 ⤷  Try a Trial
China 1951372 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for diovan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1948158 C 2016 017 Romania ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, SUB FORMA DE COMPLEX DE SARURI DE SODIU; NATIONAL AUTHORISATION NUMBER: EU/1/15/1058/001-016; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1058/001-016; DATE OF FIRST AUTHORISATION IN EEA: 20151119
1948158 122016000038 Germany ⤷  Try a 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 C01467728/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
1948158 16C0018 France ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1948158 CA 2016 00023 Denmark ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
0443983 C970001 Netherlands ⤷  Try a Trial PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM V AN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAA RIN R EEN LAAGALKYL-, FENYLLAAGALKYL-,LAAGALKENYL-,LAAGALKYNYL- ,LAAGALKOXY-LAAGALKYL-,LAAGALKOXY-LAAGALKENYL-OF LAAGALKOXY-LAA; NAT. REGISTRATION NO/DATE: RVG 20667, RVG 20668 19961104; FIRST REGISTRATION: 36983.00.00, 36983.01.00 19960513
1948158 300810 Netherlands ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIUM (3-((LS,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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