➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
McKesson
Mallinckrodt
Johnson and Johnson
Merck

Last Updated: September 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210045


Email this page to a colleague

« Back to Dashboard

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 five 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:5
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)
Paragraph IV (Patent) Challenges for 210045
Tradename Dosage Ingredient NDA Submissiondate
CONSENSI TABLET;ORAL amlodipine besylate; celecoxib 210045 2020-06-29

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:⤷  Try it FreePatent Expiration:Jun 14, 2038Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Jun 14, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
McKesson
Moodys
McKinsey
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.