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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
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.

Marketing approved:

1 Generic Name: nintedanib
Trade Name: OFEV
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

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.