lazertinib mesylate · Janssen Biotech · NDA 219008
Lazcluze
Earliest generic entry, as listed · earliest of 2 marketed strengths
1 Aug 2041
Blocked by patent: US 11850248. 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 11850248 | use U-3985 | 1 Aug 2041 |
| US 12138351 | product | 13 Apr 2041 |
| US 11879013 | use U-3985 | 21 May 2040 |
| US 12599606 | use U-4512 | 14 May 2040 |
| US 12599606 | use U-4511 | 14 May 2040 |
| US 11453656 | substance, product | 18 Apr 2038 |
| US 11981659 | use U-3985 | 18 Apr 2038 |
| US 12318390 | product | 18 Apr 2038 |
| US 9593098 | substance, product, use U-3985 | 13 Oct 2035 |
| US RE50528 | substance, product, use U-3985 | 13 Oct 2035 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 19 Aug 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 |
|---|---|---|---|
| 219008 · 001 · RLD | tablet, oral | EQ 80MG BASE | 1 Aug 2041 |
| 219008 · 002 · RLD | tablet, oral | EQ 240MG BASE | 1 Aug 2041 |