stiripentol · Biocodex Sa · NDA 206709, 207223
Diacomit
Earliest generic entry, as listed · earliest of 4 marketed strengths
14 Jul 2029
Blocked by exclusivity: ODE-403.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| ODE-403 | orphan drug (7 years) | 14 Jul 2029 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206709 · 001 · RLD | capsule, oral | 250MG | 14 Jul 2029 |
| 206709 · 002 · RLD | capsule, oral | 500MG | 14 Jul 2029 |
| 207223 · 001 · RLD | for suspension, oral | 250MG/PACKET | 14 Jul 2029 |
| 207223 · 002 · RLD | for suspension, oral | 500MG/PACKET | 14 Jul 2029 |