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Last Updated: June 14, 2021

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HYZAAR Drug Profile


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Which patents cover Hyzaar, and what generic alternatives are available?

Hyzaar is a drug marketed by Organon and is included in one NDA.

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

Paragraph IV (Patent) Challenges for HYZAAR
Tradename Dosage Ingredient NDA Submissiondate
HYZAAR TABLET;ORAL hydrochlorothiazide; losartan potassium 020387 2006-04-04
HYZAAR TABLET;ORAL hydrochlorothiazide; losartan potassium 020387 2004-05-24

US Patents and Regulatory Information for HYZAAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-001 Apr 28, 1995 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-003 Oct 20, 2005 AB RX Yes No   Get Started Free   Get Started Free   Get Started Free
Organon HYZAAR hydrochlorothiazide; losartan potassium TABLET;ORAL 020387-002 Nov 10, 1998 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
>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 HYZAAR

Supplementary Protection Certificates for HYZAAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454511 99C0009 Belgium   Get Started Free PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0253310 C950009 Netherlands   Get Started Free PRODUCT NAME: LOSARTAN, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 17617 19950314; FIRST REGISTRATION: SE 12209 19940902
0733366 98C0030 Belgium   Get Started Free PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215
0253310 SZ 16/1996 Austria   Get Started Free PRODUCT NAME: LOSARTAN-KALIUM
0253310 SPC/GB95/010 United Kingdom   Get Started Free PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
0480717 98C0025 Belgium   Get Started Free PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0443983 C00443983/03 Switzerland   Get Started Free 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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