fosphenytoin sodium · Lupin · NDA 210864
Sesquient
Earliest generic entry, as listed · earliest of 2 marketed strengths
27 Feb 2033
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9493582.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9493582 | drug product · sets the listed date | 27 Feb 2033 |
| US 7635773 | drug product | 13 Mar 2029 |
| US 8410077 | drug product | 13 Mar 2029 |
| US 9200088 | drug product | 13 Mar 2029 |
| US 9750822 | drug product | 13 Mar 2029 |
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 |
|---|---|---|---|
| 210864 · 001 · RLD · discontinued | solution, intravenous | EQ 100MG PHENYTOIN NA/2ML (EQ 50MG PHENYTOIN NA/ML) | 27 Feb 2033 |
| 210864 · 002 · RLD · discontinued | solution, intravenous | EQ 500MG PHENYTOIN NA/10ML (EQ 50MG PHENYTOIN NA/ML) | 27 Feb 2033 |