tepotinib hydrochloride · Emd Serono Inc · NDA 214096
Tepmetko
Earliest generic entry, as listed
19 Mar 2030
Blocked by patent: US 8580781.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8580781 | drug substance, drug product · sets the listed date | 19 Mar 2030 |
| US 8329692 | drug substance, drug product | 30 Oct 2029 |
| US 8927540 | use U-3078 | 21 Jul 2028 |
| US 8658643 | use U-3077 | 4 Jul 2028 |
| US 9062029 | drug product | 4 Jul 2028 |
| US 9403799 | use U-3077 | 4 Jul 2028 |
| US 8921357 | drug substance, drug product | 30 May 2028 |
| US 9284300 | drug product | 29 Apr 2028 |
Exclusivities · 1 unexpired
| ODE-325 | orphan drug (7 years) | 3 Feb 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214096 · 001 · RLD | tablet, oral | EQ 225MG BASE | 19 Mar 2030 |
Expired or delisted (1)
- NCE · 3 Feb 2026