regorafenib · Bayer Hlthcare · NDA 203085
Stivarga
Earliest generic entry, as listed
9 Jul 2032
Blocked by patent: US 9957232.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9957232 | substance | 9 Jul 2032 |
| US 9458107 | product | 8 Apr 2031 |
| US 8637553 | substance, product | 16 Feb 2031 |
| US 8680124 | use U-1506 | 2 Jun 2030 |
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 |
|---|---|---|---|
| 203085 · 001 · RLD | tablet, oral | 40MG | 9 Jul 2032 |