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Last Updated: December 6, 2022

Details for New Drug Application (NDA): 210259


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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 eight 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:7
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 210259
Generic Entry Date for 210259*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 210259
Mechanism of Action Tyrosine Kinase Inhibitors
Suppliers and Packaging for NDA: 210259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALQUENCE acalabrutinib CAPSULE;ORAL 210259 NDA AstraZeneca Pharmaceuticals LP 0310-0512 0310-0512-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-60)
CALQUENCE acalabrutinib CAPSULE;ORAL 210259 NDA AstraZeneca Pharmaceuticals LP 0310-0512 0310-0512-95 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0310-0512-95)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 31, 2017TE:RLD:Yes
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)
Regulatory Exclusivity Expiration:Oct 31, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 21, 2022
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
Harvard Business School
Boehringer Ingelheim
Mallinckrodt
McKinsey

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