gepotidacin mesylate · Glaxosmithkline · NDA 218230
Blujepa
Earliest generic entry, as listed
13 Dec 2042
Blocked by patent: US 12528809.
Listed patents · 4 unexpired
5 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12528809 | drug substance, drug product, use U-4361, U-4408 | 13 Dec 2042 |
| US 12528809 listing row | drug substance, drug product, use U-4361 · sets the listed date | 13 Dec 2042 |
| US 12528809 listing row | drug substance, drug product, use U-4408 · sets the listed date | 13 Dec 2042 |
| US 10702521 | use U-4361 | 20 Aug 2035 |
| US 11229646 | use U-4361 | 20 Aug 2035 |
| US 8389524 | drug substance, drug product, use U-4166 | 12 Feb 2029 |
Exclusivities · 3 unexpired
| GAIN | qualified infectious disease product | 25 Mar 2035 |
| NCE | new chemical entity (5 years) | 25 Mar 2030 |
| I-978 | new indication (3 years) | 11 Dec 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 |
|---|---|---|---|
| 218230 · 001 · RLD | tablet, oral | EQ 750MG BASE | 13 Dec 2042 |