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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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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
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.

Marketing approved:

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.
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