tebipenem pivoxil hydrobromide · Glaxosmithkline · NDA 215960
Utebzi
Earliest generic entry, as listed
6 Feb 2038
Blocked by patent: US 10889587.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10889587 | drug substance, drug product, use U-4570 · sets the listed date | 6 Feb 2038 |
| US 12226403 | drug product, use U-4569 | 15 Dec 2037 |
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 17 Jun 2036 |
| NCE | new chemical entity (5 years) | 17 Jun 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 |
|---|---|---|---|
| 215960 · 001 · RLD | tablet, oral | EQ 300MG BASE | 6 Feb 2038 |