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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: letermovir
Trade Name: PREVYMIS
Date Designated: 12/12/2011
Orphan Designation: Prevention of human cytomegalovirus viremia and disease in at risk populations
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: letermovir
Trade Name: PREVYMIS
Marketing Approval Date: 11/08/2017
Approved Labeled Indication: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Exclusivity End Date: 11/08/2024 
Exclusivity Protected Indication* :  Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
2 Generic Name: letermovir
Trade Name: Prevymis
Marketing Approval Date: 06/05/2023
Approved Labeled Indication: prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
Exclusivity End Date: 06/05/2030 
Exclusivity Protected Indication* :  prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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