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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: 08/28/2020
Orphan Designation: Treatment of mantle cell lymphoma
Orphan Designation Status: Designated/Approved
Loxo Oncology, Inc.
201 Haskins Way, Suite 400
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: 01/27/2023
Approved Labeled Indication: treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor
Exclusivity End Date: 01/27/2030 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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