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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: leniolisib
Trade Name: Joenja
Date Designated: 01/30/2018
Orphan Designation: Treatment of activated P13Kdelta Syndrome/p110delta-activating mutation causing senescent T cells, lymphadenopathy, and immunodeficiency
Orphan Designation Status: Designated/Approved
Pharming Technologies B.V.
Darwinweg 24
Leiden 2333CR
Netherlands

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

Marketing approved:

1 Generic Name: leniolisib
Trade Name: Joenja
Marketing Approval Date: 03/24/2023
Approved Labeled Indication: treatment of activated phosphoinositide 3-kinase delta (PI3K delta) syndrome (APDS) in adult and pediatric patients 12 years of age and older
Exclusivity End Date: 03/24/2030 
Exclusivity Protected Indication* :  treatment of activated phosphoinositide 3-kinase delta (PI3K delta) syndrome (APDS) in adult and pediatric patients 12 years of age and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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