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Alecensa · pharmadog

pharmadog
drugs
Alecensa

drug

patient view →

alectinib

Marketedupdated 2mo ago

by F. Hoffmann-La Roche Ltd

Approved

community read0 votes

indications

investigational

NSCLC

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Alecensa

generic

alectinib

indication

Non-Small Cell Lung Cancer

phase

marketed

Data sources

ClinicalTrials.gov

last refreshed 53m ago

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Patent cliff

source: FDA Orange Book

first barrier falls

Apr 18, 2027

285 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 91269314.9y
Jun 9, 2030formulationUS 94409223.9y

FDA exclusivities (2)

Apr 18, 2031ODE-477Orphan Drug (7y)4.8y
Apr 18, 2027I-947Indication (3y)285d

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Trials studying alectinib

phase3Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphismsactive not recruitingn=600
phase2A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)recruitingn=99
phase2A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumorsrecruitingn=42
—An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinibactive not recruitingn=800
phase1A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)recruitingn=30
phase2Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangementsrecruitingn=56
phase2A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)active not recruitingn=11
—Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapyrecruitingn=800

more trials →