levoketoconazole · Strongbridge · NDA 214133
Recorlev
Earliest generic entry, as listed
2 Mar 2040
Blocked by patent: US 11020393, US 11278547, US 11903940, US 12377096. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11020393 | use U-3282 · sets the listed date | 2 Mar 2040 |
| US 11278547 | use U-3282 · sets the listed date | 2 Mar 2040 |
| US 11903940 | use U-3821 · sets the listed date | 2 Mar 2040 |
| US 12377096 | use U-4236 · sets the listed date | 2 Mar 2040 |
| US 9918984 | use U-3283 | 3 May 2028 |
Exclusivities · 2 unexpired
| ODE-385 | orphan drug (7 years) | 30 Dec 2028 |
| NCE* | 30 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
- 24 Oct 2026Exclusivity expires within 90 days NCE* · 214133-00130 Dec 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214133 · 001 · RLD | tablet, oral | 150MG | 2 Mar 2040 |
Expired or delisted (4)
- US 10098877 · use U-3283 · 10 Jan 2026
- US 10517868 · use U-3283 · 10 Jan 2026
- US 10835530 · use U-3283 · 10 Jan 2026
- US 11478471 · use U-3283 · 10 Jan 2026