zoliflodacin · Entasis Therap · NDA 219491
Nuzolvence
Earliest generic entry, as listed
12 Dec 2035
Blocked by exclusivity: GAIN.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8889671 | drug substance, use U-4369 | 21 Jan 2034 |
| US 9187495 | drug substance, use U-4369 | 21 Jan 2034 |
| US 9540394 | use U-4369 | 21 Jan 2034 |
| US 9839641 | use U-4369 | 21 Jan 2034 |
| US 8658641 | drug substance | 20 Jun 2030 |
| US 9040528 | use U-4369 | 13 Oct 2029 |
Exclusivities · 2 unexpired
| GAIN | qualified infectious disease product | 12 Dec 2035 |
| NCE | new chemical entity (5 years) | 12 Dec 2030 |
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 |
|---|---|---|---|
| 219491 · 001 · RLD | for suspension, oral | 3GM/PACKET | 12 Dec 2035 |