• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
Generic Name: ibrutinib
Trade Name: Imbruvica
Date Designated: 02/02/2016
Orphan Designation: Treatment of patients with extranodal marginal zone lymphoma (mucosa associated lymphoid tissue [MALT type] lymphoma)
Orphan Designation Status: Designated/Approved
Pharmacyclics, LLC
1000 Gateway Blvd
South San Francisco, California 94080
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: 01/18/2017
Approved Labeled Indication: Treatment of patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy (indication withdrawn)
Exclusivity End Date: 05/18/2023 
Exclusivity Protected Indication* :  Treatment of patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy (indication withdrawn)

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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