pexidartinib hydrochloride · Daiichi Sankyo Inc · NDA 211810
Turalio
Earliest generic entry, as listed
24 Jul 2038
Blocked by patent: US 10435404, US 10941142, US 10961240.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10435404 | drug product · sets the listed date | 24 Jul 2038 |
| US 10941142 | drug product · sets the listed date | 24 Jul 2038 |
| US 10961240 | use U-2606 · sets the listed date | 24 Jul 2038 |
| US 10189833 | use U-2606 | 5 May 2036 |
| US 10730876 | drug substance | 5 May 2036 |
| US 9802932 | drug substance | 5 May 2036 |
| US 9358235 | use U-2606 | 8 Jun 2033 |
| US 7893075 | drug substance | 4 May 2033 |
| US 8461169 | use U-2606 | 19 Apr 2028 |
| US 8404700 | drug substance | 21 Nov 2027 |
| US 8722702 | drug substance | 21 Nov 2027 |
| US 9169250 | drug substance | 21 Nov 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 211810 · 001 · RLD · discontinued | capsule, oral | EQ 200MG BASE | 24 Jul 2038 |
| 211810 · 002 · RLD | capsule, oral | EQ 125MG BASE | 24 Jul 2038 |
Expired or delisted (2)
- ODE-250 · 2 Aug 2026
- ODE* · 2 Aug 2026