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Last Updated: January 18, 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 three 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:3
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

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   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 210045-001 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

Supplementary Protection Certificates for amlodipine besylate; celecoxib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 C300528 Netherlands   Start Trial 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
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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