NDAORALTABLETPriority Review
Approved
May 2023
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
Priority Review
PAXLOVID (COPACKAGED) (nirmatrelvir and ritonavir) by Pfizer is 2 (sars-cov-2) antiviral drug [see ]. Approved for mild-to-moderate coronavirus disease 2019 (covid-19) in adults, including hospitalization, death. First approved in 2023.
Drug data last refreshed 7h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PAXLOVID is an oral copackaged combination of nirmatrelvir and ritonavir approved for treatment of mild-to-moderate COVID-19 in adults. Nirmatrelvir is a SARS-CoV-2 protease inhibitor that blocks viral replication, while ritonavir acts as a pharmacokinetic booster by inhibiting CYP3A-mediated metabolism to increase nirmatrelvir plasma concentrations. The combination reduces risk of hospitalization and death in eligible patients.
Peak15.2 years to LOE
Product is at peak commercial stage with established market presence; commercial teams are focused on maintaining market share and optimizing utilization in core patient populations.
Mechanism of Action
2 (SARS-CoV-2) antiviral drug [see ]. Ritonavir is an HIV-1 protease inhibitor but is not active against SARS-CoV-2 M. Ritonavir inhibits the CYP3A-mediated metabolism of nirmatrelvir, resulting in increased plasma concentrations of nirmatrelvir.
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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.