maralixibat chloride · Mirum · NDA 214662, 219485
Livmarli
Earliest generic entry, as listed · earliest of 6 marketed strengths
26 Oct 2032
Other strengths are listed to 5 Oct 2043.
Blocked by patent: US 10512657, US 10512657, US 10512657, US 11229661, US 11229661, US 11229661, US 11376251, US 11376251, US 11376251, US 12350267. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 25 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12296050 | product, use U-4186 | 5 Oct 2043 |
| US 12296050 | product, use U-4187 | 5 Oct 2043 |
| US 11229647 | use U-4187 | 12 Feb 2040 |
| US 11229647 | use U-3974 | 12 Feb 2040 |
| US 11229647 | use U-3290 | 12 Feb 2040 |
| US 11497745 | use U-3974 | 12 Feb 2040 |
| US 11497745 | use U-4187 | 12 Feb 2040 |
| US 11497745 | use U-3290 | 12 Feb 2040 |
| US 11918578 | use U-3290 | 12 Feb 2040 |
| US 11918578 | use U-3974 | 12 Feb 2040 |
| US 12599602 | use U-3290 | 12 Feb 2040 |
| US 12599602 | use U-3974 | 12 Feb 2040 |
| US 10512657 | use U-4186 | 26 Oct 2032 |
| US 10512657 | use U-3973 | 26 Oct 2032 |
| US 10512657 | use U-3850 | 26 Oct 2032 |
| US 11229661 | use U-3973 | 26 Oct 2032 |
| US 11229661 | use U-4186 | 26 Oct 2032 |
| US 11229661 | use U-3850 | 26 Oct 2032 |
| US 11376251 | use U-4187 | 26 Oct 2032 |
| US 11376251 | use U-3974 | 26 Oct 2032 |
| US 11376251 | use U-3290 | 26 Oct 2032 |
| US 12350267 | use U-3973 | 26 Oct 2032 |
| US 11260053 | use U-4187 | 26 May 2031 |
| US 11260053 | use U-3290 | 26 May 2031 |
| US 11260053 | use U-3974 | 26 May 2031 |
Exclusivities · 8 unexpired
| ODE-490 | orphan drug (7 years) | 24 Jul 2031 |
| ODE-471 | orphan drug (7 years) | 13 Mar 2031 |
| ODE* | 13 Mar 2031 | |
| ODE* | 13 Mar 2030 | |
| ODE-429 | orphan drug (7 years) | 13 Mar 2030 |
| ODE-379 | orphan drug (7 years) | 29 Sep 2028 |
| ODE* | 29 Sep 2028 | |
| I-938 | new indication (3 years) | 13 Mar 2027 |
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214662 · 001 · RLD | solution, oral | EQ 9.5MG BASE/ML | 12 Feb 2040 |
| 214662 · 002 · RLD | solution, oral | EQ 19MG BASE/ML | 26 Oct 2032 |
| 219485 · 001 · RLD | tablet, oral | EQ 10MG BASE | 5 Oct 2043 |
| 219485 · 002 · RLD | tablet, oral | EQ 15MG BASE | 5 Oct 2043 |
| 219485 · 003 · RLD | tablet, oral | EQ 20MG BASE | 5 Oct 2043 |
| 219485 · 004 · RLD | tablet, oral | EQ 30MG BASE | 5 Oct 2043 |
Expired or delisted (2)
- NCE · 29 Sep 2026
- NPP · 13 Mar 2026