amoxicillin; omeprazole magnesium; rifabutin · Talicia Holdings · NDA 213004
Talicia
Earliest generic entry, as listed
27 May 2042
Blocked by patent: US 11878011. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11878011 | use U-3816 · sets the listed date | 27 May 2042 |
| US 10238606 | drug product | 12 Feb 2034 |
| US 11135172 | drug product, use U-2660 | 12 Feb 2034 |
| US 11931463 | drug product, use U-3866 | 12 Feb 2034 |
| US 9050263 | drug product, use U-2660 | 12 Feb 2034 |
| US 9498445 | drug product, use U-2660 | 12 Feb 2034 |
| US 9603806 | drug product, use U-2660 | 12 Feb 2034 |
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 1 Nov 2027 |
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 |
|---|---|---|---|
| 213004 · 001 · RLD | capsule, delayed release, oral | 250MG;EQ 10MG BASE;12.5MG | 27 May 2042 |
Expired or delisted (1)
- NP · 1 Nov 2022