infigratinib phosphate · Helsinn Hlthcare · NDA 214622
Truseltiq
Earliest generic entry, as listed · earliest of 2 marketed strengths
11 Dec 2034
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10278969, US 11160804.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10278969 | drug product · sets the listed date | 11 Dec 2034 |
| US 11160804 | drug product · sets the listed date | 11 Dec 2034 |
| US 8552002 | drug substance, drug product | 25 Aug 2029 |
| US 9067896 | drug substance | 6 Aug 2028 |
Exclusivities · 1 unexpired
| ODE-353 | orphan drug (7 years) | 28 May 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 |
|---|---|---|---|
| 214622 · 001 · RLD · discontinued | capsule, oral | 25MG | 11 Dec 2034 |
| 214622 · 002 · RLD · discontinued | capsule, oral | 100MG | 11 Dec 2034 |
Expired or delisted (1)
- NCE · 28 May 2026