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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ibrutinib
Trade Name: Imbruvica
Date Designated: 06/23/2016
Orphan Designation: Treatment of chronic Graft versus Host disease
Orphan Designation Status: Designated/Approved
Pharmacyclics, LLC
995 East Arques Avenue
Sunnyvale, California 94085
United States

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

Marketing approved:

1 Generic Name: ibrutinib
Trade Name: Imbruvica
Marketing Approval Date: 08/02/2017
Approved Labeled Indication: Treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
Exclusivity End Date: 08/02/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
2 Generic Name: ibrutinib
Trade Name: Imbruvica
Marketing Approval Date: 08/24/2022
Approved Labeled Indication: Treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy
Exclusivity End Date: 08/24/2029 
Exclusivity Protected Indication* :  Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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