NDAORALSOLUTIONPriority Review
Approved
Jul 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
REBETOL (ribavirin) by Merck & Co. is mechanism of action in cell cultures the inhibitory activity of ribavirin for respiratory syncytial virus (rsv) is selective. Approved for hospitalized infants, young children with severe lower respiratory tract infections due to rsv. First approved in 2003.
Drug data last refreshed 1h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REBETOL (ribavirin) is a small-molecule nucleoside analogue with unclear mechanism of action, possibly functioning as a cellular metabolite analogue. It is indicated for hospitalized infants and young children with severe lower respiratory tract infections caused by respiratory syncytial virus (RSV). The drug demonstrates in vitro antiviral activity against RSV, influenza, and herpes simplex virus, though clinical significance beyond RSV is unknown.
LOE Approaching
With LOE approaching and limited commercial data, the brand team is likely lean and transitioning toward maintenance mode rather than growth initiatives.
Mechanism of Action
Mechanism of Action In cell cultures the inhibitory activity of ribavirin for respiratory syncytial virus (RSV) is selective. The mechanism of action is unknown. Reversal of the in vitro antiviral activity by guanosine or xanthosine suggests ribavirin may act as an analogue of these cellular…
Indications (2)
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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.