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Last Updated: June 4, 2020

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Amlodipine besylate; celecoxib - Generic Drug Details

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What are the generic drug 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 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

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 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
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-002 May 31, 2018 RX Yes No   Start Trial   Start Trial   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 210045-001 May 31, 2018 RX Yes No   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   Start Trial
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-002 May 31, 2018 RX Yes No   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

Supplementary Protection Certificates for amlodipine besylate; celecoxib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785 C300375 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819
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
0503785 C300486 Netherlands   Start 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
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
0502314 SPC/GB11/010 United Kingdom   Start Trial PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
0443983 C00443983/03 Switzerland   Start Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
1507558 12C0033 France   Start Trial PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Johnson and Johnson
Baxter
Mallinckrodt
Harvard Business School

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