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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: patisiran
Trade Name: ONPATTRO
Date Designated: 06/14/2012
Orphan Designation: Treatment of transthyretin-mediated amyloidosis
Orphan Designation Status: Designated/Approved
Alnylam Pharmaceuticals, Inc.
300 Third Street
Cambridge, Maryland 02142
United States

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

Marketing approved:

1 Generic Name: patisiran
Trade Name: ONPATTRO
Marketing Approval Date: 08/10/2018
Approved Labeled Indication: ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Exclusivity End Date: 08/10/2025 
Exclusivity Protected Indication* :  ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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