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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: maribavir
Trade Name: Livtencity
Date Designated: 06/07/2011
Orphan Designation: Treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals USA, Inc.
500 Kendall Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: maribavir
Trade Name: Livtencity
Marketing Approval Date: 11/23/2021
Approved Labeled Indication: Treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet
Exclusivity End Date: 11/23/2028 
Exclusivity Protected Indication* :  Treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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