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Last Updated: March 28, 2024

DIOVAN HCT Drug Patent Profile


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Which patents cover Diovan Hct, and what generic alternatives are available?

Diovan Hct is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in DIOVAN HCT 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.

Paragraph IV (Patent) Challenges for DIOVAN HCT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DIOVAN HCT Tablets hydrochlorothiazide; valsartan 320 mg/12.5 mg and 320 mg/25 mg 020818 1 2007-02-07
DIOVAN HCT Tablets hydrochlorothiazide; valsartan 80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg 020818 1 2005-12-02

US Patents and Regulatory Information for DIOVAN HCT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-003 Jan 17, 2002 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 HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-004 Apr 28, 2006 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-005 Apr 28, 2006 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 HCT

International Patents for DIOVAN HCT

See the table below for patents covering DIOVAN HCT around the world.

Country Patent Number Title Estimated Expiration
Hungary T61271 ⤷  Try a Trial
European Patent Office 1767206 Formes orales solides comprenant du valsartan et de l'hydrochlorothiazide (Solid oral dosage forms comprising valsartan and hydrochlorothiazide) ⤷  Try a Trial
Cyprus 2553 Solid oral dosage forms of valsartan ⤷  Try a Trial
Japan 2003231634 SOLID ORAL DOSAGE FORM OF VALSARTAN ⤷  Try a Trial
Ireland 910548 ⤷  Try a Trial
Greece 3019155 ⤷  Try a Trial
Malaysia 146868 SOLID ORAL DOSAGE FORMS OF VALSARTAN ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DIOVAN HCT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 98C0025 Belgium ⤷  Try a Trial PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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
0565634 06C0030 France ⤷  Try a Trial PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0443983 C300445 Netherlands ⤷  Try a Trial PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0443983 C00443983/02 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
0443983 91676 Luxembourg ⤷  Try a Trial 91676, EXPIRES: 20160212
0454511 SPC/GB99/008 United Kingdom ⤷  Try a Trial PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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