sevabertinib · Bayer Healthcare · NDA 219972
Hyrnuo
Earliest generic entry, as listed
14 Nov 2043
Blocked by patent: US 12679836.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12679836 | substance, product, use U-4582 | 14 Nov 2043 |
| US 10428063 | substance, product | 10 Oct 2035 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 19 Nov 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 |
|---|---|---|---|
| 219972 · 001 · RLD | tablet, oral | 10MG | 14 Nov 2043 |