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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pirtobrutinib
Trade Name: Jaypirca
Date Designated: 09/14/2020
Orphan Designation: Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma
Orphan Designation Status: Designated/Approved
Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company
701 Gateway Boulevard
Suite 420
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: pirtobrutinib
Trade Name: Jaypirca
Marketing Approval Date: 12/01/2023
Approved Labeled Indication: treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
Exclusivity End Date: 12/01/2030 
Exclusivity Protected Indication* :  treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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