HYZAAR Drug Patent 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
Summary for HYZAAR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 106 |
Clinical Trials: | 16 |
Patent Applications: | 4,248 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for HYZAAR |
Drug Sales Revenues: | Drug sales revenues for HYZAAR |
What excipients (inactive ingredients) are in HYZAAR? | HYZAAR excipients list |
DailyMed Link: | HYZAAR at DailyMed |
Recent Clinical Trials for HYZAAR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
Centre Hospitalier Universitaire de Saint Etienne | Phase 4 |
Azidus Brasil | Phase 1 |
Pharmacology for HYZAAR
Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for HYZAAR
Paragraph IV (Patent) Challenges for HYZAAR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
HYZAAR | Tablets | hydrochlorothiazide; losartan potassium | 100 mg/12.5 mg | 020387 | 1 | 2006-04-04 |
HYZAAR | Tablets | hydrochlorothiazide; losartan potassium | 50 mg/12.5 mg and 100 mg/25 mg | 020387 | 1 | 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 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-003 | Oct 20, 2005 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 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 HYZAAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-003 | Oct 20, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HYZAAR
See the table below for patents covering HYZAAR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 85312 | PROCESSO PARA A PREPARACAO DE IMIDAZOIS BLOQUEADORES DOS RECEPTORES DE ANGIOTENSINA II E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM | ⤷ Try a Trial |
European Patent Office | 0736021 | ⤷ Try a Trial | |
Denmark | 359687 | ⤷ Try a Trial | |
Spain | 2063734 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HYZAAR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0502314 | C300095 | Netherlands | ⤷ Try a Trial | PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419 |
0565634 | 06C0030 | France | ⤷ Try a Trial | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 |
0733366 | 98C0030 | Belgium | ⤷ Try a Trial | PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215 |
0253310 | SPC/GB95/010 | United Kingdom | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |