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Last Updated: April 25, 2024

diovan hct Drug Patent Profile


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When do Diovan Hct patents expire, 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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-005 Apr 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-003 Jan 17, 2002 ⤷  Try a Trial ⤷  Try a Trial
Novartis DIOVAN HCT hydrochlorothiazide; valsartan TABLET;ORAL 020818-002 Mar 6, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for diovan hct

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0443983 98C004 Belgium ⤷  Try a Trial PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925
0443983 91676 Luxembourg ⤷  Try a Trial 91676, EXPIRES: 20160212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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