Nirmatrelvir
As of the edition of 20 October 2026, Nirmatrelvir is a small molecule: marketed, first approved in 2022 (CA); US protection ends in 2041.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Paxlovid (copackaged)
- First approved
- 17 January 2022 (CA)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- Pfizer; 2 holders in all
- Registered trials
- 62, 7 stopped early
- Disease areas
- Infections; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Immune system
US protection
US protection ends in 2041.
The last listed US drug-substance patent ends in 2041. The application that gives this date is held by Pfizer.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 17 | 11 | 1 | 1 |
| Phase 1 | 21 | 16 | 0 | 4 |
| Phase 2 | 12 | 6 | 5 | 1 |
| Phase 3 | 9 | 4 | 3 | 1 |
| Phase 4 | 3 | 1 | 1 | 0 |
| All trials | 62 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 2021 to now |