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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: spesolimab-sbzo
Trade Name: Spevigo
Date Designated: 10/03/2018
Orphan Designation: Treatment of generalized pustular psoriasis
Orphan Designation Status: Designated/Approved
Boehringer Ingelheim Pharmaceuticals, Inc. (BI)
900 Ridgebury Road
P.O. Box 368
Ridgefield, Connecticut 06877
United States

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

Marketing approved:

1 Generic Name: spesolimab-sbzo
Trade Name: Spevigo
Marketing Approval Date: 09/01/2022
Approved Labeled Indication: Treatment of generalized pustular psoriasis (GPP) flares in adults
Exclusivity End Date: 09/01/2029 
Exclusivity Protected Indication* :  Treatment of generalized pustular psoriasis (GPP) flares in adults
2 Generic Name: spesolimab-sbzo
Trade Name: Spevigo
Marketing Approval Date: 03/18/2024
Approved Labeled Indication: treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg
Exclusivity End Date: 03/18/2031 
Exclusivity Protected Indication* :  treatment of generalized pustular psoriasis (GPP) flares in pediatric patients 12 years of age and older and weighing at least 40 kg, and treatment of GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg who are not experiencing a flare
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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