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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: irinotecan liposome injection
Trade Name:
Date Designated: 07/21/2011
Orphan Designation: Treatment of pancreatic cancer
Orphan Designation Status: Designated/Approved
Ipsen Biopharmaceuticals, Inc.
One Main Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: irinotecan liposome injection
Trade Name:
Marketing Approval Date: 10/22/2015
Approved Labeled Indication: For use in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas that has progressed following gemcitabine-based therapy
Exclusivity End Date: 10/22/2022 
Exclusivity Protected Indication* :  For use in combination with 5-fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas that has progressed following gemcitabine-based therapy
2 Generic Name: irinotecan liposome injection
Trade Name: Onivyde
Marketing Approval Date: 02/13/2024
Approved Labeled Indication: in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma
Exclusivity End Date: 02/13/2031 
Exclusivity Protected Indication* :  first-line treatment of adult patients with metastatic pancreatic adenocarcinoma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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