nifurtimox · Bayer Healthcare · NDA 213464
Lampit
Earliest generic entry, as listed · earliest of 2 marketed strengths
6 Aug 2027
Blocked by exclusivity: ODE-319.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| ODE-319 | orphan drug (7 years) | 6 Aug 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
- Enters 12-month window basis: exclusivity · 213464-002Listed date 6 Aug 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 213464-001Listed date 6 Aug 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213464 · 001 · RLD | tablet, oral | 30MG | 6 Aug 2027 |
| 213464 · 002 · RLD | tablet, oral | 120MG | 6 Aug 2027 |