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AMLODIPINE BESYLATE; CELECOXIB - Generic Drug Details
What are the generic drug sources for amlodipine besylate; celecoxib and what is the scope of patent protection?
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 nine patent family members in seven countries.
There are fifty drug master file entries for amlodipine besylate; celecoxib. One supplier is listed for this compound.
Summary for AMLODIPINE BESYLATE; CELECOXIB
| International Patents: | 9 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 50 |
| Suppliers / Packagers: | 1 |
| 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 |
Pharmacology for AMLODIPINE BESYLATE; CELECOXIB
| Drug Class | Nonsteroidal Anti-inflammatory Drug Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Cyclooxygenase Inhibitors Calcium Channel Antagonists |
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 | 210045-001 | May 31, 2018 | RX | Yes | No | Start Trial | Start Trial | 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 | 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 |
| Australia | 2009260632 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2019008583 | 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 |
|---|---|---|---|---|
| 1507558 | 2012/018 | Ireland | Start Trial | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705 |
| 1003503 | 05C0048 | France | Start Trial | PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707 |
| 0443983 | 2007C/043 | Belgium | Start Trial | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 |
| 0443983 | C00443983/03 | Switzerland | Start Trial | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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