fruquintinib · Takeda Pharms Usa · NDA 217564
Fruzaqla
Earliest generic entry, as listed · earliest of 2 marketed strengths
7 Sep 2035
Blocked by patent: US 10519142, US 11046674.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10519142 | drug substance, drug product, use U-3753 · sets the listed date | 7 Sep 2035 |
| US 11046674 | use U-3753 · sets the listed date | 7 Sep 2035 |
| US 7829574 | drug substance, drug product | 23 Mar 2032 |
| US 8212033 | use U-3753 | 9 May 2028 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 8 Nov 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217564 · 001 · RLD | capsule, oral | 1MG | 7 Sep 2035 |
| 217564 · 002 · RLD | capsule, oral | 5MG | 7 Sep 2035 |