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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pembrolizumab
Trade Name: Keytruda
Date Designated: 06/12/2017
Orphan Designation: Treatment of hepatocellular carcinoma (HCC)
Orphan Designation Status: Designated/Approved
Merck Sharp & Dohme LLC
126 East Lincoln Ave.
P.O. Box 2000
Rahway, New Jersey 07065
United States

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

Marketing approved:

1 Generic Name: pembrolizumab
Trade Name: Keytruda
Marketing Approval Date: 11/09/2018
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Exclusivity End Date: 11/09/2025 
Exclusivity Protected Indication* :  KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
2 Generic Name: pembrolizumab
Trade Name: Keytruda
Marketing Approval Date: 01/25/2024
Approved Labeled Indication: treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen
Exclusivity End Date: 01/25/2031 
Exclusivity Protected Indication* :  treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen and other than sorafenib
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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