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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: avapritinib
Trade Name: Ayvakit
Date Designated: 01/21/2016
Orphan Designation: Treatment of mastocytosis
Orphan Designation Status: Designated/Approved
Blueprint Medicines Corporation
45 Sidney Street
Cambridge, Massachusetts 02139
United States

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

Marketing approved:

1 Generic Name: avapritinib
Trade Name: Ayvakit
Marketing Approval Date: 06/16/2021
Approved Labeled Indication: Treatment of adult patients with advanced systemic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
Exclusivity End Date: 06/16/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with advanced systemic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL).
2 Generic Name: avapritinib
Trade Name: Ayvakit
Marketing Approval Date: 05/22/2023
Approved Labeled Indication: treatment of adult patients with indolent systemic mastocytosis (ISM)
Exclusivity End Date: 05/22/2030 
Exclusivity Protected Indication* :  treatment of adult patients with indolent systemic mastocytosis (ISM)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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