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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: 07/06/2016
Orphan Designation: Treatment of systemic sclerosis (including the associated interstitial lung disease).
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: 09/06/2019
Approved Labeled Indication: OFEV is indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).
Exclusivity End Date: 09/06/2026 
Exclusivity Protected Indication* :  Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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