midostaurin · Novartis · NDA 207997
Rydapt
Earliest generic entry, as listed
2 Dec 2030
Blocked by patent: US 8575146. 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 8575146 | use U-2008 | 2 Dec 2030 |
| US 7973031 | use U-2007 | 9 Oct 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 207997 · 001 · RLD | capsule, oral | 25MG | 2 Dec 2030 |