sotorasib · Amgen Inc · NDA 214665
Lumakras
Earliest generic entry, as listed · earliest of 3 marketed strengths
15 Sep 2040
Blocked by patent: US 11426404, US 11426404. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11426404 | use U-4107 | 15 Sep 2040 |
| US 11426404 | use U-3306 | 15 Sep 2040 |
| US 11236091 | substance, product, use U-4107 | 20 May 2040 |
| US 11236091 | substance, product, use U-3306 | 20 May 2040 |
| US 11827635 | substance, product, use U-4107 | 20 May 2040 |
| US 11827635 | substance, product, use U-3306 | 20 May 2040 |
| US 12398133 | substance, product, use U-3306 | 20 May 2040 |
| US 12398133 | substance, product, use U-4107 | 20 May 2040 |
| US 12280056 | use U-4107 | 18 Nov 2039 |
| US 10519146 | substance, product | 21 May 2038 |
Exclusivities · 4 unexpired
| ODE-507 | orphan drug (7 years) | 16 Jan 2032 |
| ODE-352 | orphan drug (7 years) | 28 May 2028 |
| ODE* | 28 May 2028 | |
| I-962 | new indication (3 years) | 16 Jan 2028 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214665 · 001 · RLD | tablet, oral | 120MG | 15 Sep 2040 |
| 214665 · 002 · RLD | tablet, oral | 320MG | 15 Sep 2040 |
| 214665 · 003 · RLD | tablet, oral | 240MG | 15 Sep 2040 |
Expired or delisted (1)
- NCE · 28 May 2026