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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: beremagene geperpavec-svdt
Trade Name: Vyjuvek
Date Designated: 11/02/2017
Orphan Designation: Treatment of dystrophic epidermolysis bullosa
Orphan Designation Status: Designated/Approved
Krystal Biotech, Inc.
2100 Wharton Street
Suite 701
Pittsburgh, Pennsylvania 15203
United States

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

Marketing approved:

1 Generic Name: beremagene geperpavec-svdt
Trade Name: Vyjuvek
Marketing Approval Date: 05/19/2023
Approved Labeled Indication: treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene
Exclusivity End Date: 05/19/2030 
Exclusivity Protected Indication* :  treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene
2 Generic Name: beremagene geperpavec-svdt
Trade Name: Vyjuvek
Marketing Approval Date: 09/12/2025
Approved Labeled Indication: treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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