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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: pemetrexed disodium
Trade Name: Alimta
Date Designated: 08/28/2001
Orphan Designation: Treatment of malignant pleural mesothelioma
Orphan Designation Status: Designated/Approved
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
United States

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

Marketing approved:

1 Generic Name: pemetrexed disodium
Trade Name: Alimta
Marketing Approval Date: 02/04/2004
Approved Labeled Indication: Treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery
Exclusivity End Date: 02/04/2011 
Exclusivity Protected Indication* :  

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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