prednisolone acetate · Sun Pharma Canada · NDA 022067
Flo-Pred
Earliest generic entry, as listed · earliest of 2 marketed strengths
11 Oct 2028
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7799331.
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7799331 | drug product, use U-1068, U-139 | 11 Oct 2028 |
| US 7799331 listing row | drug product, use U-1068 · sets the listed date | 11 Oct 2028 |
| US 7799331 listing row | drug product, use U-139 · sets the listed date | 11 Oct 2028 |
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 |
|---|---|---|---|
| 022067 · 001 · discontinued | suspension, oral | EQ 5MG BASE/5ML | 11 Oct 2028 |
| 022067 · 002 · discontinued | suspension, oral | EQ 15MG BASE/5ML | 11 Oct 2028 |