NDAORALTABLETPriority Review
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
RILUTEK (riluzole) by Italfarmaco Research is 12. First approved in 1995.
Drug data last refreshed 2m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RILUTEK (riluzole) is an oral small-molecule therapeutic approved in 1995 for amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease. The exact mechanism of action remains unknown, though riluzole is believed to modulate glutamate-mediated excitotoxicity. It represents one of the few disease-modifying treatments available for ALS patients.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential downsizing of brand commercial teams and transition focus toward generic transition planning.
Mechanism of Action
12.1 Mechanism of Action The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown. 12.2 Pharmacodynamics The clinical pharmacodynamics of riluzole has not been determined in humans. 12.3 Pharmacokinetics Table 2 displays the pharmacokinetic parameters of…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.