Last reviewed · How we verify
Paxlovid (Copackaged) (Nirmatrelvir)
Nirmatrelvir inhibits SARS-CoV-2 main protease; ritonavir inhibits CYP3A-mediated metabolism of nirmatrelvir.
PAXLOVID (nirmatrelvir/ritonavir) is indicated for treatment of mild-to-moderate COVID-19 in adults at high risk for severe disease progression. Nirmatrelvir is a potent SARS-CoV-2 main protease inhibitor boosted by ritonavir, a CYP3A inhibitor that increases nirmatrelvir exposure. The combination carries significant drug interaction risk as a strong CYP3A inhibitor, requiring careful medication review and potential dose adjustments. PAXLOVID is not approved for pre-exposure or post-exposure prophylaxis.
At a glance
| Generic name | Nirmatrelvir |
|---|---|
| Sponsor | Pfizer |
| Drug class | Antiviral protease inhibitor |
| Target | SARS-CoV-2 main protease (Mpro, 3CLpro, nsp5 protease) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Nirmatrelvir is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antiviral drug that targets the viral main protease. Ritonavir is an HIV-1 protease inhibitor that is not active against SARS-CoV-2 Mpro but serves as a pharmacokinetic booster. Ritonavir inhibits the CYP3A-mediated metabolism of nirmatrelvir, resulting in increased plasma concentrations of nirmatrelvir and enhanced antiviral efficacy.
Approved indications
- COVID-19
Common side effects
- Dysgeusia
- Diarrhoea
- dysgeusia
- diarrhoea
- Taste disorder
- headache
- fatigue
- Nausea
- myalgia
- nausea
- dyspnoea
- decreased appetite
Drug interactions
- CYP3A substrates (drugs primarily metabolized by CYP3A)
- CYP2D6 substrates
- P-glycoprotein (P-gp) substrates
- OATP1B1 substrates
- CYP3A inducers (strong)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Paxlovid (Copackaged) CI brief — competitive landscape report
- Paxlovid (Copackaged) updates RSS · CI watch RSS
- Pfizer portfolio CI