alpelisib · Novartis · NDA 215039, 218466
Vijoice
Earliest generic entry, as listed · earliest of 4 marketed strengths
17 Feb 2037
Blocked by patent: US 11433059, US 12427141. 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 11433059 | use U-4359 | 17 Feb 2037 |
| US 12427141 | use U-4288 | 17 Feb 2037 |
| US 8227462 | substance, product | 29 Apr 2033 |
| US 8476268 | substance, product | 10 Sep 2029 |
Exclusivities · 1 unexpired
| ODE-396 | orphan drug (7 years) | 5 Apr 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 |
|---|---|---|---|
| 215039 · 001 · RLD | tablet, oral | 50MG | 17 Feb 2037 |
| 215039 · 002 · RLD | tablet, oral | 125MG | 17 Feb 2037 |
| 215039 · 003 · RLD | tablet, oral | 200MG | 17 Feb 2037 |
| 218466 · 001 · RLD | granule, oral | 50MG/PACKET | 17 Feb 2037 |