eflornithine hydrochloride · Uswm · NDA 215500
Iwilfin
Earliest generic entry, as listed
12 Feb 2036
Blocked by patent: US 12582625. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12582625 | use U-4444 · sets the listed date | 12 Feb 2036 |
Exclusivities · 2 unexpired
| ODE-462 | orphan drug (7 years) | 13 Dec 2030 |
| NP | new product | 13 Dec 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
- Exclusivity expires within 90 days NP · 215500-001Exclusivity expires 13 Dec 2026Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215500 · 001 · RLD | tablet, oral | EQ 192MG BASE | 12 Feb 2036 |