Details for New Drug Application (NDA): 210259

NDA 210259 describes CALQUENCE, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the CALQUENCE profile page.

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

Summary for 210259

Tradename:	CALQUENCE
Applicant:	Astrazeneca
Ingredient:	acalabrutinib
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210259

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Oct 31, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 16, 2028
Regulatory Exclusivity Use:	IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA (MCL) WHO ARE INELIGIBLE FOR AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT)
Regulatory Exclusivity Expiration:	Nov 21, 2026
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Patent:		Patent Expiration:	Jul 1, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

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