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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: palopegteriparatide
Trade Name: Yorvipath
Date Designated: 06/04/2018
Orphan Designation: Treatment of hypoparathyroidism
Orphan Designation Status: Designated/Approved
Ascendis Pharma Bone Diseases A/S
Tuborg Boulevard 12
DK-2900
Hellerup
Denmark

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

Marketing approved:

1 Generic Name: palopegteriparatide
Trade Name: Yorvipath
Marketing Approval Date: 08/09/2024
Approved Labeled Indication: treatment of hypoparathyroidism in adults
Exclusivity End Date: 08/09/2031 
Exclusivity Protected Indication* :  treatment of hypoparathyroidism in adults

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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