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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pirfenidone
Trade Name: ESBRIET
Date Designated: 03/05/2004
Orphan Designation: Treatment of idiopathic pulmonary fibrosis
Orphan Designation Status: Designated/Approved
Legacy Pharma Inc.
Off Fairbanks Road, PO Box CEC 290
George Town, Grand Cayman KY1-9012
Cayman Islands

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

Marketing approved:

1 Generic Name: pirfenidone
Trade Name: ESBRIET
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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