sodium oxybate · Alkermes Inc · NDA 214755
Lumryz
Earliest generic entry, as listed · earliest of 4 marketed strengths
16 Mar 2042
Blocked by patent: US 11779557. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 30 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11779557 | use U-3705 · sets the listed date | 16 Mar 2042 |
| US 11583510 | use U-3578 | 7 Feb 2042 |
| US 10272062 | drug product | 21 Jul 2037 |
| US 10736866 | drug product | 21 Jul 2037 |
| US 10952986 | use U-3601 | 21 Jul 2037 |
| US 10973795 | drug product | 21 Jul 2037 |
| US 11000498 | drug product, use U-3580 | 21 Jul 2037 |
| US 11052061 | drug product | 21 Jul 2037 |
| US 11065224 | drug product | 21 Jul 2037 |
| US 11400065 | use U-3579 | 21 Jul 2037 |
| US 11504347 | drug product | 21 Jul 2037 |
| US 11602512 | use U-3577 | 21 Jul 2037 |
| US 11602513 | use U-3576 | 21 Jul 2037 |
| US 11766418 | drug product | 21 Jul 2037 |
| US 11826335 | use U-3751 | 21 Jul 2037 |
| US 11839597 | drug product | 21 Jul 2037 |
| US 11896572 | drug product | 21 Jul 2037 |
| US 11986451 | use U-3934 | 21 Jul 2037 |
| US 12097175 | drug product | 21 Jul 2037 |
| US 12097176 | use U-4006 | 21 Jul 2037 |
| US 12109186 | drug product | 21 Jul 2037 |
| US 12115142 | drug product | 21 Jul 2037 |
| US 12115143 | drug product | 21 Jul 2037 |
| US 12115144 | drug product | 21 Jul 2037 |
| US 12115145 | drug product | 21 Jul 2037 |
| US 12128021 | use U-4022 | 21 Jul 2037 |
| US 12138239 | drug product | 21 Jul 2037 |
| US 12144793 | drug product | 21 Jul 2037 |
| US 12303478 | use U-4189 | 21 Jul 2037 |
| US 12728110 | drug product | 21 Jul 2037 |
Exclusivities · 2 unexpired
| ODE-494 | orphan drug (7 years) | 16 Oct 2031 |
| ODE-431 | orphan drug (7 years) | 1 May 2030 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214755 · 001 · RLD | for suspension, extended release, oral | 4.5GM/PACKET | 16 Mar 2042 |
| 214755 · 002 · RLD | for suspension, extended release, oral | 6GM/PACKET | 16 Mar 2042 |
| 214755 · 003 · RLD | for suspension, extended release, oral | 7.5GM/PACKET | 16 Mar 2042 |
| 214755 · 004 · RLD | for suspension, extended release, oral | 9GM/PACKET | 16 Mar 2042 |
Expired or delisted (1)
- NP · 1 May 2026