fexinidazole · Sanofi · NDA 214429
Fexinidazole
Earliest generic entry, as listed
16 Jul 2028
Blocked by exclusivity: ODE-359.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| ODE-359 | orphan drug (7 years) | 16 Jul 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 |
|---|---|---|---|
| 214429 · 001 · RLD | tablet, oral | 600MG | 16 Jul 2028 |
Expired or delisted (1)
- NCE · 16 Jul 2026