remibrutinib · Novartis · NDA 218436
Rhapsido
Earliest generic entry, as listed
19 Jan 2043
Blocked by patent: US 12419889. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12419889 | use U-4281 | 19 Jan 2043 |
| US 10457647 | use U-4280 | 13 Nov 2034 |
| US 9512084 | substance, product | 13 Nov 2034 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 30 Sep 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218436 · 001 · RLD | tablet, oral | 25MG | 19 Jan 2043 |