brigatinib · Takeda Pharms Usa · NDA 208772
Alunbrig
Earliest generic entry, as listed · earliest of 3 marketed strengths
10 Nov 2035
Blocked by patent: US 10385078.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10385078 | substance, product, use U-2837 | 10 Nov 2035 |
| US 9611283 | use U-2837 | 10 Apr 2034 |
| US 9012462 | substance | 28 Apr 2031 |
| US 9273077 | use U-2837 | 21 May 2029 |
Exclusivities · 1 unexpired
| ODE-300 | orphan drug (7 years) | 22 May 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208772 · 001 · RLD | tablet, oral | 30MG | 10 Nov 2035 |
| 208772 · 002 · RLD | tablet, oral | 90MG | 10 Nov 2035 |
| 208772 · 003 · RLD | tablet, oral | 180MG | 10 Nov 2035 |