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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: acalabrutinib
Trade Name:
Date Designated: 05/13/2015
Orphan Designation: Treatment of chronic lymphocytic leukemia (CLL).
Orphan Designation Status: Designated/Approved
Acerta Pharma, LLC (a member of the AstraZeneca Group)
121 Oyster Point Boulevard
South San Francisco, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: acalabrutinib
Trade Name:
Marketing Approval Date: 11/21/2019
Approved Labeled Indication: CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Exclusivity End Date: 11/21/2026 
Exclusivity Protected Indication* :  Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
2 Generic Name: acalabrutinib
Trade Name: Calquence
Marketing Approval Date: 08/04/2022
Approved Labeled Indication: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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