Details for New Drug Application (NDA): 211155

NDA 211155 describes COPIKTRA, which is a drug marketed by Secura 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 COPIKTRA profile page.

The generic ingredient in COPIKTRA is duvelisib. One supplier is listed for this compound. Additional details are available on the duvelisib profile page.

Summary for 211155

Tradename:	COPIKTRA
Applicant:	Secura
Ingredient:	duvelisib
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211155

Dosage:

CAPSULE;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.

Suppliers and Packaging for NDA: 211155

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COPIKTRA	duvelisib	CAPSULE;ORAL	211155	NDA	Secura Bio, Inc	73116-215	73116-215-28	28 CAPSULE in 1 PACKAGE (73116-215-28)
COPIKTRA	duvelisib	CAPSULE;ORAL	211155	NDA	Secura Bio, Inc	73116-215	73116-215-56	56 CAPSULE in 1 PACKAGE (73116-215-56)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Sep 24, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 24, 2025
Regulatory Exclusivity Use:	TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) AFTER AT LEAST TWO PRIOR THERAPIES
Patent:		Patent Expiration:	Jan 10, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Feb 13, 2030	Product Flag?		Substance Flag?	Y	Delist Request?

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