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AMLODIPINE BESYLATE; CELECOXIB - Generic Drug Details
What are the generic sources for amlodipine besylate; celecoxib and what is the scope of freedom to operate?
Amlodipine besylate; celecoxib
is the generic ingredient in one branded drug marketed by Coeptis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amlodipine besylate; celecoxib has eight patent family members in six countries.
There are fifty drug master file entries for amlodipine besylate; celecoxib.
Summary for AMLODIPINE BESYLATE; CELECOXIB
| International Patents: | 8 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 50 |
| Clinical Trials: | 3 |
| DailyMed Link: | AMLODIPINE BESYLATE; CELECOXIB at DailyMed |
Recent Clinical Trials for AMLODIPINE BESYLATE; CELECOXIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
| Kitov Pharmaceuticals, Ltd. | Phase 3 |
US Patents and Regulatory Information for AMLODIPINE BESYLATE; CELECOXIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Coeptis | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-003 | May 31, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Coeptis | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-003 | May 31, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Coeptis | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-001 | May 31, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Coeptis | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-002 | May 31, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Coeptis | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-003 | May 31, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for AMLODIPINE BESYLATE; CELECOXIB
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2011100659 | Start Trial |
| Mexico | 2010012836 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2019008583 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009154944 | Start Trial |
| Canada | 2726337 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMLODIPINE BESYLATE; CELECOXIB
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0678503 | C300499 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
| 1915993 | C300625 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 |
| 1915993 | 92315 | Luxembourg | Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE |
| 0503785 | CA 2011 00026 | Denmark | Start 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 |
| 0443983 | C300445 | Netherlands | Start Trial | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
