Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	rituximab
Trade Name:	Rituxan
Date Designated:	02/14/2006
Orphan Designation:	Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome)
Orphan Designation Status:	Designated/Approved
Sponsor:	Genentech, Inc. 1 DNA Way South San Francisco, California 94080 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	rituximab
	Trade Name:	Rituxan
	Marketing Approval Date:	04/19/2011
	Approved Labeled Indication:	For the use of Rituxan (rituximab) in combination with glucocorticoids for the treatment of patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA). )
	Exclusivity End Date:	04/19/2018
	Exclusivity Protected Indication* :

2	Generic Name:	rituximab
	Trade Name:	Rituxan
	Marketing Approval Date:	09/27/2019
	Approved Labeled Indication:	RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener?s Granulomatosis) and Microscopic Polyangiitis (MPA)
	Exclusivity End Date:	09/27/2026
	Exclusivity Protected Indication* :	indicated in combination with glucocorticoids, for the treatment of pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.