futibatinib · Taiho Oncology · NDA 214801
Lytgobi
Earliest generic entry, as listed
5 Nov 2039
Blocked by patent: US 11833151.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11833151 | drug product · sets the listed date | 5 Nov 2039 |
| US 10434103 | drug substance, drug product | 31 Mar 2036 |
| US 9108973 | drug substance, drug product, use U-3456 | 13 Feb 2033 |
Exclusivities · 3 unexpired
| ODE-410 | orphan drug (7 years) | 30 Sep 2029 |
| ODE* | 30 Sep 2029 | |
| NCE | new chemical entity (5 years) | 30 Sep 2027 |
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 |
|---|---|---|---|
| 214801 · 001 · RLD | tablet, oral | 4MG | 5 Nov 2039 |
| 214801 · 002 · RLD · discontinued | tablet, oral | 16MG | 5 Nov 2039 |