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Last Updated: October 27, 2021

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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 patent protection?

Amlodipine besylate; celecoxib is the generic ingredient in one branded drug marketed by Coeptis and is included in one NDA. There are five 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.

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

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; CELECOXIB
Tradename Dosage Ingredient NDA Submissiondate
CONSENSI TABLET;ORAL amlodipine besylate; celecoxib 210045 2020-06-29

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-003 May 31, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Coeptis CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-002 May 31, 2018 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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
0443983 2007C/043 Belgium ⤷  Try it Free PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1507558 C300528 Netherlands ⤷  Try it Free PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0503785 CA 2011 00026 Denmark ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
Johnson and Johnson
McKesson
AstraZeneca
Harvard Business School

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