• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
Generic Name: rituximab
Trade Name: Rituxan
Date Designated: 06/13/1994
Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way, MS 242
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: rituximab
Trade Name: Rituxan
Marketing Approval Date: 11/26/1997
Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma
Exclusivity End Date: 11/26/2004 
Exclusivity Protected Indication* :  
2 Generic Name: rituximab
Trade Name: Rituxan
Marketing Approval Date: 12/02/2021
Approved Labeled Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy
Exclusivity End Date: 12/02/2028 
Exclusivity Protected Indication* :  treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL)

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