NDAORALFILM
Approved
Nov 2019
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
EXSERVAN (riluzole) by Italfarmaco Research is 12. First approved in 2019.
Drug data last refreshed 2h ago · AI intelligence enriched 8h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXSERVAN (riluzole) is an oral film formulation of riluzole, a small-molecule therapeutic for amyotrophic lateral sclerosis (ALS). The mechanism of action in ALS remains unknown, though riluzole is believed to modulate glutamate neurotransmission. It represents a convenient oral delivery alternative to existing riluzole formulations.
$0.409MPart D
PeakStable
Product is at peak lifecycle with modest Part D spending ($409K, 126 claims in 2023), indicating a niche but established market presence with stable demand.
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.