NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
OSMOLEX ER (amantadine hydrochloride) by Supernus Pharmaceuticals is clinical pharmacology pharmacodynamics mechanism of action antiviral the mechanism by which amantadine exerts its antiviral activity is not clearly understood. Approved for schizophrenia. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OSMOLEX ER is an extended-release oral formulation of amantadine hydrochloride, an antiviral and anti-Parkinsonian agent. It treats schizophrenia, schizoaffective disorder, and glioblastoma multiforme through a mechanism involving NMDA receptor antagonism and weak dopaminergic effects. The drug was approved in 2018 and is currently in peak commercial lifecycle.
$2MPart D
Peak11.8 years to LOELow commercial volume ($2M in Part D spending) suggests small patient base and likely a modest-sized brand team relative to major competitors.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics Mechanism of Action Antiviral The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the…
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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.