BENICAR Drug Patent Profile
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Which patents cover Benicar, and when can generic versions of Benicar launch?
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. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; olmesartan medoxomil profile page.
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: | 4,730 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for BENICAR
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| 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 | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | AB | RX | Yes | Yes | ⤷ 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 | |||
| 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 | |||
| >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 | 021286-003 | Apr 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-003 | Apr 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-004 | Apr 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| Cosette | BENICAR | olmesartan medoxomil | TABLET;ORAL | 021286-001 | Apr 25, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Hong Kong | 1011361 | ⤷ Try a Trial | |
| European Patent Office | 0573218 | Dérivés de 4-carboxyimidazole comme antagonistes de l'angiotensine II et leur application en thérapeutique (4-Carboxyimidazoles as angiotensin II antagonists and their thrapeutic use) | ⤷ Try a Trial |
| Hungary | 9200578 | ⤷ Try a Trial | |
| Germany | 10299043 | ⤷ Try a Trial | |
| Luxembourg | 91847 | ⤷ Try a Trial | |
| Germany | 60119368 | ⤷ Try a Trial | |
| Portugal | 503785 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BENICAR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0503785 | SPC/GB03/024 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHAMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 50202.00.00 20020813; DE 50202.01.00 20020813; DE 50202.02.00 20020813; DE 50205.00.00 20020813; DE 50205.01.00 20020813; DE 50205.02.00 20020813; UK PL 08265/0015 20030522; UK PL 08265/0016 20030522; UK PL08265/0017 20030522 |
| 0503785 | C300486 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216 |
| 0503785 | C00503785/04 | Switzerland | ⤷ Try a Trial | FORMER REPRESENTATIVE: BOHEST AG, CH |
| 0503785 | CA 2011 00026 | Denmark | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 |
| 0503785 | 20/2009 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON OLMESARTAN MEDOXOMIL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, MIT AMLODIPINBESILAT; NAT. REGISTRATION NO/DATE: 1-27894, 1-27895, 1-27896 20081217; FIRST REGISTRATION: NL 100989, 100990, 100991 20080819 |
| 0503785 | 91330 | Luxembourg | ⤷ Try a Trial | CERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS) |
| 0503785 | CA 2006 00012 | Denmark | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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