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Last Updated: February 20, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210045


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NDA 210045 describes CONSENSI, which is a drug marketed by Coeptis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the CONSENSI profile page.

The generic ingredient in CONSENSI is amlodipine besylate; celecoxib. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine besylate; celecoxib profile page.
Summary for 210045
Tradename:CONSENSI
Applicant:Coeptis
Ingredient:amlodipine besylate; celecoxib
Patents:2
Generic Entry Opportunity Date for 210045
Generic Entry Date for 210045*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 210045
Suppliers and Packaging for NDA: 210045
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045 NDA Burke Therapeutics, LLC 69101-502 69101-502-30 30 TABLET in 1 BOTTLE (69101-502-30)
CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045 NDA Burke Therapeutics, LLC 69101-502 69101-502-50 500 TABLET in 1 BOTTLE (69101-502-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE;200MG
Approval Date:May 31, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 31, 2021
Regulatory Exclusivity Use:NEW COMBINATION
Patent:  Start TrialPatent Expiration:Jun 14, 2038Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:May 22, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

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