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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-])
3 Generic Name: letermovir
Trade Name: Prevymis
Marketing Approval Date: 08/30/2024
Approved Labeled Indication: prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
Exclusivity End Date: TBD  
4 Generic Name: letermovir
Trade Name: Prevymis
Marketing Approval Date: 08/30/2024
Approved Labeled Indication: prophylaxis of cytomegalovirus (CMV) disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
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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