flotufolastat f-18 gallium · Blue Earth · NDA 216023
Posluma
Earliest generic entry, as listed
27 Nov 2041
Blocked by patent: US 12036290, US 12427207.
Listed patents · 6 unexpired
8 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12036290 | drug product, use U-3614, U-3615 | 27 Nov 2041 |
| US 12036290 listing row | drug product, use U-3614 · sets the listed date | 27 Nov 2041 |
| US 12036290 listing row | drug product, use U-3615 · sets the listed date | 27 Nov 2041 |
| US 12427207 | drug product · sets the listed date | 27 Nov 2041 |
| US 11413360 | drug substance, use U-3614, U-3615 | 22 Nov 2038 |
| US 11413360 listing row | drug substance, use U-3614 | 22 Nov 2038 |
| US 11413360 listing row | drug substance, use U-3615 | 22 Nov 2038 |
| US 12357711 | drug substance | 22 Nov 2038 |
| US 12377176 | drug substance | 22 Nov 2038 |
| US 12390540 | drug substance | 23 Aug 2038 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 25 May 2028 |
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 |
|---|---|---|---|
| 216023 · 001 · RLD | solution, intravenous | 25ML (8-158mCi/ML) | 27 Nov 2041 |