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 | 020387-002 | Nov 10, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | ⤷ 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 |
---|---|---|---|
European Patent Office | 0479903 | IMIDAZOLES SUBSTITUES UTILES COMME INHIBITEURS DE L'ANGIOTENSIN II (SUBSTITUTED IMIDAZOLES USEFUL AS ANGIOTENSIN II BLOCKERS) | ⤷ Try a Trial |
Cyprus | 2187 | Pharmaceutical compositions comprising angiotensinii receptor blocking imidazoles and diuretics | ⤷ Try a Trial |
Japan | H0529351 | ⤷ Try a Trial | |
Canada | 1338238 | IMIDAZOLES BLOQUANT LES RECEPTEURS DE L'ANGIOTENSINE II ET COMBINAISONS DE CES IMIDAZOLES AVEC DES DIURETIQUES ET DES ANTI-INFLAMMATOIRES NON STEROIDIENS (ANGIOTENSIN II RECEPTOR BLOCKING IMIDAZOLES AND COMBINATIONS THEREOF WITH DIURETICS AND NSAIDS) | ⤷ Try a Trial |
Norway | 872863 | ⤷ 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 |
---|---|---|---|---|
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 |
0733366 | SPC/GB98/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412 |
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 | C00443983/03 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |