alectinib hydrochloride · Hoffmann-La Roche · NDA 208434
Alecensa
Earliest generic entry, as listed
24 Apr 2035
Blocked by patent: US 10350214, US 11433076.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10350214 | drug product · sets the listed date | 24 Apr 2035 |
| US 11433076 | drug product · sets the listed date | 24 Apr 2035 |
| US 9365514 | drug product | 4 Mar 2032 |
| US 9126931 | drug substance | 29 May 2031 |
| US 9440922 | drug product | 9 Jun 2030 |
Exclusivities · 2 unexpired
| ODE-477 | orphan drug (7 years) | 18 Apr 2031 |
| I-947 | new indication (3 years) | 18 Apr 2027 |
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 |
|---|---|---|---|
| 208434 · 001 · RLD | capsule, oral | EQ 150MG BASE | 24 Apr 2035 |