sepiapterin · Ptc Therap · NDA 219666
Sephience
Earliest generic entry, as listed · earliest of 2 marketed strengths
6 Mar 2042
Blocked by patent: US 12257252. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12257252 | use U-4250 · sets the listed date | 6 Mar 2042 |
| US 11752154 | drug product, use U-4251 | 4 Sep 2038 |
| US 12213982 | use U-4251 | 4 Sep 2038 |
| US 11072614 | drug substance, use U-4251 | 16 Apr 2038 |
Exclusivities · 2 unexpired
| ODE-542 | orphan drug (7 years) | 28 Jul 2032 |
| NCE | new chemical entity (5 years) | 28 Jul 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219666 · 001 · RLD | powder, oral | 250MG/PACKET | 6 Mar 2042 |
| 219666 · 002 · RLD | powder, oral | 1GM/PACKET | 6 Mar 2042 |