pafolacianine sodium · On Target Labs · NDA 214907
Cytalux
Earliest generic entry, as listed
29 Nov 2035
Blocked by patent: US 9061057.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9061057 | substance, product, use U-3291 | 29 Nov 2035 |
| US 9254341 | substance, product | 4 Oct 2033 |
| US 10881747 | substance, product, use U-3291 | 26 Aug 2033 |
| US 9333270 | substance, product, use U-3291 | 26 Aug 2033 |
| US 9341629 | substance, product | 26 Aug 2033 |
| US 9789208 | substance, product, use U-3291 | 26 Aug 2033 |
Exclusivities · 2 unexpired
| ODE-390 | orphan drug (7 years) | 29 Nov 2028 |
| NCE | new chemical entity (5 years) | 29 Nov 2026 |
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
- 24 Oct 2026Exclusivity expires within 90 days NCE · 214907-00129 Nov 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214907 · 001 · RLD | solution, intravenous | EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | 29 Nov 2035 |