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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lumasiran
Trade Name: Oxlumo
Date Designated: 02/08/2016
Orphan Designation: Treatment of primary hyperoxaluria type 1
Orphan Designation Status: Designated/Approved
Alnylam Pharmaceuticals
300 Third Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: lumasiran
Trade Name: Oxlumo
Marketing Approval Date: 11/23/2020
Approved Labeled Indication: treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients
Exclusivity End Date: 11/23/2027 
Exclusivity Protected Indication* :  treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients
2 Generic Name: lumasiran
Trade Name: Oxlumo
Marketing Approval Date: 10/06/2022
Approved Labeled Indication: Treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients
Exclusivity End Date: 10/06/2029 
Exclusivity Protected Indication* :  Treatment of primary hyperoxaluria type 1 (PH1) to lower plasma oxalate levels in pediatric and adult patients
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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