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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
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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