benicar hct Drug Patent Profile
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Which patents cover Benicar Hct, and what generic alternatives are available?
Benicar Hct is a drug marketed by Cosette and is included in one NDA.
The generic ingredient in BENICAR HCT is hydrochlorothiazide; olmesartan medoxomil. There are thirty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Benicar Hct
A generic version of benicar hct was approved as hydrochlorothiazide; olmesartan medoxomil by ALKEM LABS LTD on July 11th, 2024.
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Summary for benicar hct
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 17 |
Drug Prices: | Drug price information for benicar hct |
Drug Sales Revenues: | Drug sales revenues for benicar hct |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for benicar hct |
What excipients (inactive ingredients) are in benicar hct? | benicar hct excipients list |
DailyMed Link: | benicar hct at DailyMed |
Recent Clinical Trials for benicar hct
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
Daiichi Sankyo Co., Ltd. | N/A |
Chinese PLA General Hospital | Phase 4 |
Pharmacology for benicar hct
Drug Class | Angiotensin 2 Receptor Blocker Thiazide Diuretic |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Physiological Effect | Increased Diuresis |
Paragraph IV (Patent) Challenges for BENICAR HCT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BENICAR HCT | Tablets | hydrochlorothiazide; olmesartan medoxomil | 20 mg/12.5 mg | 021532 | 1 | 2007-05-11 |
BENICAR HCT | Tablets | hydrochlorothiazide; olmesartan medoxomil | 40 mg/12.5 mg and 40 mg/25 mg | 021532 | 1 | 2007-02-15 |
US Patents and Regulatory Information for benicar hct
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | AB | RX | Yes | Yes | ⤷ 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 benicar hct
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for benicar hct
See the table below for patents covering benicar hct around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 304516 | ⤷ Sign Up | |
Taiwan | 228521 | ⤷ Sign Up | |
Russian Federation | 2086541 | ПРОИЗВОДНЫЕ ИМИДАЗОЛА ИЛИ ИХ ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫЕ СЛОЖНЫЕ ЭФИРЫ И СПОСОБ ИХ ПОЛУЧЕНИЯ (IMIDAZOLE DERIVATIVES OR THEIR PHARMACEUTICALLY ACCEPTABLE ESTERS AND A METHOD OF THEIR SYNTHESIS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for benicar hct
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0503785 | CA 2009 00015 | Denmark | ⤷ Sign Up | PRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819 |
0480717 | 98C0025 | Belgium | ⤷ Sign Up | PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215 |
0503785 | 91571 | Luxembourg | ⤷ Sign Up | 91571, EXPIRES: 20170221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |