levetiracetam · Tripoint · NDA 204417
Elepsia Xr
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 Oct 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8431156, US 8470367.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8431156 | drug product · sets the listed date | 31 Oct 2027 |
| US 8470367 | drug product · sets the listed date | 31 Oct 2027 |
| US 8163306 | drug product | 3 Sep 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 |
|---|---|---|---|
| 204417 · 001 · RLD · discontinued | tablet, extended release, oral | 1GM | 31 Oct 2027 |
| 204417 · 002 · RLD · discontinued | tablet, extended release, oral | 1.5GM | 31 Oct 2027 |
Expired or delisted (2)
- US 8425938 · product · 22 Feb 2026
- US 8535717 · product · 22 Feb 2026