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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: nivolumab
Trade Name: OPDIVO
Date Designated: 08/07/2014
Orphan Designation: Treatment of Hodgkin lymphoma
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
Route 206 & Province Line Road
P. O. Box 4000
Princeton, New Jersey 08543
United States

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

Marketing approved:

1 Generic Name: nivolumab
Trade Name: OPDIVO
Marketing Approval Date: 05/17/2016
Approved Labeled Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
Exclusivity End Date: 05/17/2023 
Exclusivity Protected Indication* :  Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
2 Generic Name: nivolumab
Trade Name: OPDIVO
Marketing Approval Date: 04/25/2017
Approved Labeled Indication: Treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or 3 or more lines of systemic therapy that includes autologous HSCT.
Exclusivity End Date: 04/25/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after 3 or more lines of systemic therapy that includes autologous HSCT, not including any overlap with the orphan exclusivity awarded for the 2016 marketing approval of nivolumab for the treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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