Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	lorlatinib
Trade Name:	Lorbrena
Date Designated:	06/23/2015
Orphan Designation:	Treatment of anaplastic lymphoma kinase (ALK)-positive or ROS1-positive non-small cell lung cancer
Orphan Designation Status:	Designated/Approved
Sponsor:	Pfizer, Inc. 235 East 42nd Street New York, New York 10017 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	lorlatinib
	Trade Name:	Lorbrena
	Marketing Approval Date:	11/02/2018
	Approved Labeled Indication:	LORBRENA® is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease.
	Exclusivity End Date:	11/02/2025
	Exclusivity Protected Indication* :	LORBRENA® is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease.

2	Generic Name:	lorlatinib
	Trade Name:	Lorbrena
	Marketing Approval Date:	03/03/2021
	Approved Labeled Indication:	treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
	Exclusivity End Date:	03/03/2028
	Exclusivity Protected Indication* :	Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test, excluding patients whose disease has progressed on crizotinib and at least one other ALK inhibitor; or alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.