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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: copanlisib
Trade Name: ALIQOPA
Date Designated: 02/05/2015
Orphan Designation: Treatment of follicular lymphoma
Orphan Designation Status: Designated/Approved
Bayer US LLC
100 Bayer Boulevard
P. O. Box 915
Hanover, New Jersey 07981
United States

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

Marketing approved:

1 Generic Name: copanlisib
Trade Name: ALIQOPA
Marketing Approval Date: 09/14/2017
Approved Labeled Indication: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Exclusivity End Date: 09/14/2024 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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