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Last Updated: December 7, 2019

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AMLODIPINE BESYLATE; CELECOXIB - Generic Drug Details

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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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Kitov Pharmaceuticals, Ltd.Phase 3

See all AMLODIPINE BESYLATE; CELECOXIB clinical trials

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

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

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Serving leading biopharmaceutical companies globally:

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