drug
alectinib
Marketedupdated 3mo agoby F. Hoffmann-La Roche Ltd
Approvedcommunity read0 votes
indications
investigational
NSCLC
all catalysts(0)
nothing on the calendar yet
Trials studying alectinib
- phase2Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
- phase3A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
- phase3Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
- phase3Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms
- phase2A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
- phase2A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors
- —An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
- phase1A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Apr 18, 2027
248 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (5)
- Apr 24, 2035formulationUS 10350214
- Apr 24, 2035formulationUS 11433076
- Mar 4, 2032formulationUS 9365514
- May 29, 2031compositionUS 91269314.8y
- Jun 9, 2030formulationUS 94409223.8y
FDA exclusivities (2)
- Apr 18, 2031ODE-477Orphan Drug (7y)4.7y
- Apr 18, 2027I-947Indication (3y)248d
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