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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 and ipilimumab
Trade Name: OPDIVO® and YERVOY®
Date Designated: 08/16/2017
Orphan Designation: Treatment of mesothelioma
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 and ipilimumab
Trade Name: OPDIVO® and YERVOY®
Marketing Approval Date: 10/02/2020
Approved Labeled Indication: OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
Exclusivity End Date: 10/02/2027 
Exclusivity Protected Indication* :  OPDIVO (nivolumab) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma
2 Generic Name: nivolumab and ipilimumab
Trade Name: OPDIVO® and YERVOY®
Marketing Approval Date: 10/02/2020
Approved Labeled Indication: YERVOY® (ipilimumab), in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
Exclusivity End Date: 10/02/2027 
Exclusivity Protected Indication* :  YERVOY® (ipilimumab) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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