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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: 08/22/2016
Orphan Designation: Treatment of esophageal cancer
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
P. O. Box 5326
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: 06/10/2020
Approved Labeled Indication: Opdivo (nivolumab) indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Exclusivity End Date: 06/10/2027 
Exclusivity Protected Indication* :  For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
2 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 04/16/2021
Approved Labeled Indication: in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity End Date: 04/16/2028 
Exclusivity Protected Indication* :  treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
3 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 05/20/2021
Approved Labeled Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity End Date: 05/20/2028 
Exclusivity Protected Indication* :  adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
4 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 05/27/2022
Approved Labeled Indication: In combination with ipilimumab, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
Exclusivity End Date: 05/27/2029 
Exclusivity Protected Indication* :  First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
5 Generic Name: nivolumab
Trade Name: Opdivo
Marketing Approval Date: 05/27/2022
Approved Labeled Indication: In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
Exclusivity End Date: 05/27/2029 
Exclusivity Protected Indication* :  First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC)
*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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