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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: epcoritamab-bysp
Trade Name: Epkinly
Date Designated: 03/01/2022
Orphan Designation: Treatment of follicular lymphoma
Orphan Designation Status: Designated/Approved
Genmab US, Inc.
777 Scudders Mill Road
Bldg. 2, 4th Floor
Plainsboro, New Jersey 08536
United States

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

Marketing approved:

1 Generic Name: epcoritamab-bysp
Trade Name: Epkinly
Marketing Approval Date: 06/26/2024
Approved Labeled Indication: treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
Exclusivity End Date: 06/26/2031 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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