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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: brigatinib
Trade Name: Alunbrig
Date Designated: 04/28/2016
Orphan Designation: Treatment of anaplastic lymphoma kinase-positive (ALK+), c-ros 1 oncogene positive (ROS1+), or epidermal growth factor receptor positive (EGFR+) non-small cell lung cancer (NSCLC).
Orphan Designation Status: Designated/Approved
Takeda Development Center Americas, Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
United States

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

Marketing approved:

1 Generic Name: brigatinib
Trade Name: Alunbrig
Marketing Approval Date: 04/28/2017
Approved Labeled Indication: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
Exclusivity End Date: 04/28/2024 
Exclusivity Protected Indication* :  Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
2 Generic Name: brigatinib
Trade Name: Alunbrig
Marketing Approval Date: 05/22/2020
Approved Labeled Indication: ALUNBRIG (brigatinib) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Exclusivity End Date: 05/22/2027 
Exclusivity Protected Indication* :  For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test, not including patients who have progressed on or are intolerant to crizotinib.

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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