Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	afatinib
Trade Name:	Gilotrif
Date Designated:	12/03/2012
Orphan Designation:	Treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
Orphan Designation Status:	Designated/Approved
Sponsor:	Boehringer Ingelheim Pharmaceuticals, Inc. 900 Ridgebury Road P. O. Box 368 Ridgefield, Connecticut 06877 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	afatinib
	Trade Name:	Gilotrif
	Marketing Approval Date:	07/12/2013
	Approved Labeled Indication:	First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
	Exclusivity End Date:	07/12/2020
	Exclusivity Protected Indication* :	First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

2	Generic Name:	afatinib
	Trade Name:	Gilotrif
	Marketing Approval Date:	01/12/2018
	Approved Labeled Indication:	GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
	Exclusivity End Date:	01/12/2025
	Exclusivity Protected Indication* :	GILOTRIF is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations other than exon 19 deletions or exon 21 (L858R) substiution mutationas as detected by an FDA-approved test.

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