Details for New Drug Application (NDA): 210045

NDA 210045 describes CONSENSI, which is a drug marketed by Purple Biotech and is included in one NDA. 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. Additional details are available on the amlodipine besylate; celecoxib profile page.

Summary for 210045

Tradename:	CONSENSI
Applicant:	Purple Biotech
Ingredient:	amlodipine besylate; celecoxib
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210045

Constraining patent/regulatory exclusivity:

9,662,315

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE;200MG
Approval Date:	May 31, 2018	TE:		RLD:	Yes
Patent:	10,350,171	Patent Expiration:	Jun 14, 2038	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,925,835	Patent Expiration:	Jun 14, 2038	Product 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
Patent:	10,945,960	Patent Expiration:	Jun 14, 2038	Product Flag?	Y	Substance Flag?		Delist Request?

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