fluciclovine f-18 · Blue Earth · NDA 208054
Axumin
Earliest generic entry, as listed
23 Apr 2042
Blocked by patent: US 11980674. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11980674 | use U-2450 | 23 Apr 2042 |
| US 10124079 | use U-2450 | 30 Dec 2035 |
| US 10716868 | use U-2450 | 30 Dec 2035 |
| US 10933147 | use U-2450 | 30 Dec 2035 |
| US 10967077 | use U-2450 | 30 Dec 2035 |
| US 10010632 | product | 28 Nov 2026 |
| US 10953112 | use U-1879 | 28 Nov 2026 |
| US 9387266 | use U-1879 | 28 Nov 2026 |
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 |
|---|---|---|---|
| 208054 · 001 · RLD | solution, intravenous | 9-221mCi/ML | 23 Apr 2042 |