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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: dupilumab
Trade Name: Dupixent
Date Designated: 09/05/2017
Orphan Designation: Treatment of eosinophilic esophagitis
Orphan Designation Status: Designated/Approved
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
United States

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

Marketing approved:

1 Generic Name: dupilumab
Trade Name: Dupixent
Marketing Approval Date: 05/20/2022
Approved Labeled Indication: Treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE)
Exclusivity End Date: 05/20/2029 
Exclusivity Protected Indication* :  Treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE)
2 Generic Name: dupilumab
Trade Name: Dupixent
Marketing Approval Date: 01/25/2024
Approved Labeled Indication: treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE)
Exclusivity End Date: 01/25/2031 
Exclusivity Protected Indication* :  treatment of pediatric patients aged 1 year and older weighing at least 15 kg who are less than 12 years of age or less than 40 kg in weight with eosinophilic esophagitis (EoE)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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