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. Thirty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.
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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: | 4,267 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-003 | Oct 20, 2005 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-002 | Nov 10, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | HYZAAR | hydrochlorothiazide; losartan potassium | TABLET;ORAL | 020387-001 | Apr 28, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Norway | 872863 | ⤷ Sign Up | |
| Denmark | 5189 | ⤷ Sign Up | |
| Hungary | 218461 | Szubsztituált imidazolszármazékok, és hatóanyagként e vegyületeket tartalmazó gyógyszerkészítmények (SUBSTITUTED IMIDAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AS ACTIVE INGREDIENTS) | ⤷ Sign Up |
| Finland | 890070 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607 |
| 0253310 | SZ 16/1996 | Austria | ⤷ Sign Up | PRODUCT NAME: LOSARTAN-KALIUM |
| 0502314 | SPC/GB02/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419 |
| 0253310 | SPC/GB95/010 | United Kingdom | ⤷ Sign Up | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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