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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	nedosiran
Trade Name:	Rivfloza
Date Designated:	05/15/2018
Orphan Designation:	Treatment of primary hyperoxaluria
Orphan Designation Status:	Designated/Approved
Sponsor:	Dicerna Pharmaceuticals, Inc. (a wholly owned subsidiary of Novo Nordisk) 75 Hayden Avenue Lexington, Massachusetts 02421 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	nedosiran
	Trade Name:	Rivfloza
	Marketing Approval Date:	09/29/2023
	Approved Labeled Indication:	to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR greater than or equal to 30 mL/min/1.73 m2
	Exclusivity End Date:	09/29/2030
	Exclusivity Protected Indication* :	to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR greater than or equal to 30 mL/min/1.73 m2

2	Generic Name:	nedosiran
	Trade Name:	Rivfloza
	Marketing Approval Date:	03/27/2025
	Approved Labeled Indication:	to lower urinary oxalate levels in children 2 years of age and older and adults with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR greater than or equal to 30 mL/min/1.73 m2
	Exclusivity End Date:	03/27/2032
	Exclusivity Protected Indication* :	to lower urinary oxalate levels in children 2 to less than 9 years of age with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function, e.g., eGFR greater than or equal to 30 mL/min/1.73 m2

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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