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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Combination of nivolumab and ipilimumab
Trade Name:
Date Designated: 10/09/2014
Orphan Designation: Treatment of Stage IIb to Stage IV melanoma
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
5 Research Parkway
Wallingford, Connecticut 06492
United States

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

Marketing approved:

1 Generic Name: Combination of nivolumab and ipilimumab
Trade Name:
Marketing Approval Date: 09/30/2015
Approved Labeled Indication: Treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma
Exclusivity End Date: 09/30/2022 
Exclusivity Protected Indication* :  Treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma
2 Generic Name: ipilimumab
Trade Name: Yervoy
Marketing Approval Date: 02/15/2023
Approved Labeled Indication: as a single agent or in combination with nivolumab, for the treatment of unresectable or metastatic melanoma in adult and pediatric patients 12 years and older
Exclusivity End Date: TBD  
3 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 02/15/2023
Approved Labeled Indication: as a single agent or in combination with ipilimumab, for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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