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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ipilimumab
Trade Name: Yervoy
Date Designated: 06/03/2004
Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma
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: ipilimumab
Trade Name: Yervoy
Marketing Approval Date: 03/25/2011
Approved Labeled Indication: Treatment of unresectable or metastatic melanoma
Exclusivity End Date: 03/25/2018 
Exclusivity Protected Indication* :  
2 Generic Name: ipilimumab
Trade Name: Yervoy
Marketing Approval Date: 10/28/2015
Approved Labeled Indication: For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy.
Exclusivity End Date: 10/28/2022 
Exclusivity Protected Indication* :  For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy.
3 Generic Name: ipilimumab
Trade Name: Yervoy
Marketing Approval Date: 07/21/2017
Approved Labeled Indication: treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older)
Exclusivity End Date: 07/21/2024 
Exclusivity Protected Indication* :  treatment of unresectable or metastatic melanoma in pediatric patients (12 years and older).
4 Generic Name: ipilimumab
Trade Name: Yervoy
Marketing Approval Date: 05/25/2021
Approved Labeled Indication: In combination with nivolumab, for the treatment of unresectable or metastatic melanoma in adult patients
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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