danicopan · Alexion Pharms Inc · NDA 218037
Voydeya
Earliest generic entry, as listed · earliest of 2 marketed strengths
2 Aug 2038
Blocked by patent: US 12076319. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12076319 | use U-3933 | 2 Aug 2038 |
| US 9796741 | substance, use U-3933 | 29 Mar 2038 |
Exclusivities · 2 unexpired
| ODE-476 | orphan drug (7 years) | 29 Mar 2031 |
| NCE | new chemical entity (5 years) | 29 Mar 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218037 · 001 · RLD | tablet, oral | 50MG | 2 Aug 2038 |
| 218037 · 002 · RLD | tablet, oral | 100MG | 2 Aug 2038 |