NDAORALTABLETPriority Review
Approved
Jul 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Mechanism of Action
Protein Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Clinical Trials (5)
Pemigatinib + Afatinib in Advanced Refractory Solid Tumors
Started Apr 2024
70 enrolled
Advanced Solid TumorUnresectable Solid TumorMetastatic Solid Tumor+1 more
Observational Study of Afatinib 30 mg Daily
Started Oct 2022
69 enrolled
Non-Small Cell Lung CancerEpidermal Growth Factor Receptor Mutation
Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma
Started Oct 2022
20 enrolled
Chordoma of Clivus
Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma
Started Oct 2021
25 enrolled
Squamous Cell Carcinoma
Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma
Started Aug 2021
805 enrolled
Non-squamous, Non-Small Cell Lung Cancer
Loss of Exclusivity
LOE Date
Jan 5, 2031
58 months away
Patent Expiry
Jan 5, 2031
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| RE43431 | Jan 13, 2026Expired | Substance | — |
| RE43431*PED | Jul 13, 2026 | — | |
| 9539258 | Nov 9, 2026 | U-1950 | |
| 9539258*PED | May 9, 2027 | — | |
| 8426586 | Oct 10, 2029 | Substance | — |