Benicar HCT Drug Patent Profile
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When do Benicar Hct patents expire, and when can generic versions of Benicar Hct launch?
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. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
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 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for Benicar HCT
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | AB | RX | Yes | Yes | ⤷ 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-005 | Jun 5, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-002 | Jun 5, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Germany | 69231798 | ⤷ Try a Trial | |
China | 1101384 | ⤷ Try a Trial | |
South Korea | 100656716 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Benicar HCT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0503785 | C00503785/03 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
0503785 | C300133 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: OLMESARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN DE CARBOXYGROEP GEKOZEN UIT DE VOLGENDE : EEN ALKYLGROEP 1-4 KOOLSTOFATOMEN, EEN BENZYLGROEP, EEN ALKANOYLOXYALKYLGROEP WAARIN HET ALKANOYLDEEL 1-5; NATL. REGISTRATION NO/DATE: RVG 28785-RVG 28787 20030527; FIRST REGISTRATION: DE 502.02.00.00,502.02.01.00, 502.02.02.00 20020813 |
0503785 | C00503785/02 | Switzerland | ⤷ Try a Trial | FORMER OWNER: SANKYO COMPANY LIMITED, JP |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |