zidesamtinib · Nuvalent · NDA 220185
Jideytro
Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Sep 2042
Blocked by patent: US 12043626, US 12630560.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12043626 | substance, product | 30 Sep 2042 |
| US 12630560 | use U-4579 | 30 Sep 2042 |
| US 11542278 | substance, product | 5 May 2041 |
| US 12054498 | use U-4579 | 5 May 2041 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 22 Jul 2031 |
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 |
|---|---|---|---|
| 220185 · 001 · RLD | tablet, oral | 25MG | 30 Sep 2042 |
| 220185 · 002 · RLD | tablet, oral | 100MG | 30 Sep 2042 |