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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Ripretinib
Trade Name:
Date Designated: 10/02/2014
Orphan Designation: Treatment of gastrointestinal stromal tumors (GIST)
Orphan Designation Status: Designated/Approved
Deciphera Pharmaceuticals, LLC
200 Smith Street
Waltham, Massachusetts 02451
United States

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

Marketing approved:

1 Generic Name: Ripretinib
Trade Name:
Marketing Approval Date: 05/15/2020
Approved Labeled Indication: QINLOCK (ripretinib) is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Exclusivity End Date: 05/15/2027 
Exclusivity Protected Indication* :  Indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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