tovorafenib · Day One Biopharms · NDA 217700, 218033
Ojemda
Earliest generic entry, as listed · earliest of 2 marketed strengths
23 Jun 2035
Blocked by patent: US 10426782.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10426782 | product | 23 Jun 2035 |
| US 8293752 | substance, product | 4 Aug 2031 |
Exclusivities · 2 unexpired
| ODE-478 | orphan drug (7 years) | 23 Apr 2031 |
| NCE | new chemical entity (5 years) | 23 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217700 · 001 · RLD | tablet, oral | 100MG | 23 Jun 2035 |
| 218033 · 001 · RLD | for suspension, oral | 25MG/ML | 23 Jun 2035 |