ensitrelvir · Shionogi · NDA 220442
Xocova
Earliest generic entry, as listed
1 May 2042
Blocked by patent: US 11814368, US 12559474.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11814368 | drug substance, drug product, use U-4553 · sets the listed date | 1 May 2042 |
| US 12559474 | drug substance, drug product, use U-4553 · sets the listed date | 1 May 2042 |
| US 9150546 | drug substance, drug product | 12 Dec 2030 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 29 May 2031 |
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 |
|---|---|---|---|
| 220442 · 001 · RLD | tablet, oral | 125MG | 1 May 2042 |