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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: 01/23/2013
Orphan Designation: Treatment of Stage IIb to IV melanoma
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Co.
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: 12/22/2014
Approved Labeled Indication: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
Exclusivity End Date: 12/22/2021 
Exclusivity Protected Indication* :  Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
2 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 12/20/2017
Approved Labeled Indication: Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
Exclusivity End Date: 12/20/2024 
Exclusivity Protected Indication* :  Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
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: 02/15/2030 
Exclusivity Protected Indication* :  Treatment of pediatric patients 12 years and older with unresectable or metastatic melanoma
4 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 02/15/2023
Approved Labeled Indication: adjuvant treatment of adult and pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
Exclusivity End Date: 02/15/2030 
Exclusivity Protected Indication* :  adjuvant treatment of pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
5 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 10/13/2023
Approved Labeled Indication: adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma
Exclusivity End Date: 10/13/2030 
Exclusivity Protected Indication* :  adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB or Stage IIC melanoma
*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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