BENICAR Drug Patent Profile
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When do Benicar patents expire, and what generic alternatives are available?
Benicar is a drug marketed by Cosette and is included in two NDAs.
The generic ingredient in BENICAR 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
A generic version of BENICAR was approved as hydrochlorothiazide; olmesartan medoxomil by ALKEM LABS LTD on July 11th, 2024.
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Questions you can ask:
- What is the 5 year forecast for BENICAR?
- What are the global sales for BENICAR?
- What is Average Wholesale Price for BENICAR?
Summary for BENICAR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 17 |
Patent Applications: | 4,600 |
Drug Prices: | Drug price information for BENICAR |
Drug Sales Revenues: | Drug sales revenues for BENICAR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BENICAR |
What excipients (inactive ingredients) are in BENICAR? | BENICAR excipients list |
DailyMed Link: | BENICAR at DailyMed |
Recent Clinical Trials for BENICAR
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
Drug Class | Angiotensin 2 Receptor Blocker |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Paragraph IV (Patent) Challenges for BENICAR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BENICAR | Tablets | olmesartan medoxomil | 5 mg, 20 mg and 40 mg | 021286 | 1 | 2006-04-25 |
US Patents and Regulatory Information for BENICAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
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 | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | AB | RX | Yes | Yes | ⤷ 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 | |||
Cosette | BENICAR HCT | hydrochlorothiazide; olmesartan medoxomil | TABLET;ORAL | 021532-003 | Jun 5, 2003 | 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 BENICAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BENICAR
See the table below for patents covering BENICAR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 0115516 | ⤷ Sign Up | |
Norway | 332938 | ⤷ Sign Up | |
Ireland | 920540 | ⤷ Sign Up | |
Norway | 20032261 | ⤷ Sign Up | |
China | 1698603 | ⤷ Sign Up | |
European Patent Office | 0503785 | Dérivés de 1-biphénylimidazole, leur préparation et leur utilisation thérapeutique (1-Biphenylimidazole derivatives, their preparation and their therapeutic use) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BENICAR
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 |
0503785 | 91571 | Luxembourg | ⤷ Sign Up | 91571, EXPIRES: 20170221 |
0503785 | 91330 | Luxembourg | ⤷ Sign Up | CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS) |
0503785 | C00503785/02 | Switzerland | ⤷ Sign Up | FORMER OWNER: SANKYO COMPANY LIMITED, JP |
0503785 | 03C0037 | France | ⤷ Sign Up | PRODUCT NAME: OLMESARTAN MEDOXOMIL; NAT. REGISTRATION NO/DATE: NL28292 20030806; FIRST REGISTRATION: DE - 50202.00 20020813 |
0503785 | 9/2011 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AUS OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, AMLODIPIN BESILAT UND HYDROCHLOROTHIAZID; NAT. REGISTRATION NO/DATE: 1-30068 - 1-30072 20110216; FIRST REGISTRATION: DE 79810.00.00 - 79814.00.00, UND 79815.00.00 - 79819.00.00 20101216 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |