nirmatrelvir; ritonavir · Pfizer · NDA 217188
Paxlovid (Copackaged)
Earliest generic entry, as listed
31 Oct 2041
Blocked by patent: US 11541034. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11541034 | use U-3629 | 31 Oct 2041 |
| US 11351149 | substance, product, use U-3629 | 5 Aug 2041 |
Exclusivities · 2 unexpired
| NCE | new chemical entity (5 years) | 25 May 2028 |
| D-195 | new dosing schedule | 31 Jan 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217188 · 001 · RLD | tablet, oral | 150MG;100MG | 31 Oct 2041 |