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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  nintedanib
Trade Name:  OFEV
Date Designated:  06/29/2011
Orphan Designation:  Treatment of patients with idiopathic pulmonary fibrosis.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/15/2014 
Approved Labeled Indication:  Treatment of idiopathic pulmonary fibrosis
Exclusivity End Date:    10/15/2021 
Exclusivity Protected Indication* :  Treatment of idiopathic pulmonary fibrosis
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
P. O. Box 368
Ridgefield, Connecticut 06877
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.