ensartinib hydrochloride · Xcovery · NDA 218171
Ensacove
Earliest generic entry, as listed · earliest of 2 marketed strengths
1 Jun 2037
Blocked by patent: US 10899744.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10899744 | substance, use U-4099 | 1 Jun 2037 |
| US 9126947 | substance | 29 Nov 2031 |
| US 9296724 | substance, use U-4099 | 18 Jun 2029 |
| US 8551995 | substance | 9 Feb 2029 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 18 Dec 2029 |
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 |
|---|---|---|---|
| 218171 · 001 · RLD | capsule, oral | EQ 25MG BASE | 1 Jun 2037 |
| 218171 · 002 · RLD | capsule, oral | EQ 100MG BASE | 1 Jun 2037 |