fluocinolone acetonide · Alimera Sciences Inc · NDA 201923
Iluvien
Earliest generic entry, as listed
7 Nov 2028
Blocked by patent: US 9849027.
Listed patents · 2 unexpired
3 Orange Book listing rows for 2 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9849027 | drug product, use U-4157, U-708 | 7 Nov 2028 |
| US 9849027 listing row | drug product, use U-4157 · sets the listed date | 7 Nov 2028 |
| US 9849027 listing row | drug product, use U-708 · sets the listed date | 7 Nov 2028 |
| US 8871241 | drug product | 12 Aug 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201923 · 001 · RLD | implant, intravitreal | 0.19MG | 7 Nov 2028 |