levetiracetam · Aprecia Pharms · NDA 207958
Spritam
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Mar 2034
Blocked by patent: US 11160786, US 9339489, US 9669009.
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11160786 | drug product · sets the listed date | 14 Mar 2034 |
| US 9339489 | drug product, use U-1850 · sets the listed date | 14 Mar 2034 |
| US 9669009 | use U-1850, U-2021, U-2022 | 14 Mar 2034 |
| US 9669009 listing row | use U-1850 · sets the listed date | 14 Mar 2034 |
| US 9669009 listing row | use U-2021 · sets the listed date | 14 Mar 2034 |
| US 9669009 listing row | use U-2022 · sets the listed date | 14 Mar 2034 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207958 · 001 · RLD | tablet, for suspension, oral | 250MG | 14 Mar 2034 |
| 207958 · 002 · RLD | tablet, for suspension, oral | 500MG | 14 Mar 2034 |
| 207958 · 003 · RLD · discontinued | tablet, for suspension, oral | 750MG | 14 Mar 2034 |
| 207958 · 004 · RLD · discontinued | tablet, for suspension, oral | 1GM | 14 Mar 2034 |