FDA Orange Book · active-ingredient family
Maralixibat chloride
Maralixibat chloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
2
Brand (NDA)
0
Generics (ANDA)
10
Listed patents
19
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIVMARLIRLD×4 | MIRUM | NDA 219485 | — | Apr 10, 2025 | |
| LIVMARLIRLD×2 | MIRUM | NDA 214662 | — | Sep 29, 2021 |
Marketing exclusivity (19)
- I-938New indication exclusivity (3 years)
Mar 13, 2027
in 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
- NPPNew patient population exclusivity (3 years)
Mar 13, 2026
3 mo ago
- ODE-379Orphan-drug exclusivity (7 years)
Sep 29, 2028
in 2 yr 4 mo
- ODE-429Orphan-drug exclusivity (7 years)
Mar 13, 2030
in 3 yr 9 mo
- ODE-471Orphan-drug exclusivity (7 years)
Mar 13, 2031
in 4 yr 10 mo
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
- ODE*FDA marketing exclusivity
Mar 13, 2031
in 4 yr 10 mo
- ODE*FDA marketing exclusivity
Sep 29, 2028
in 2 yr 4 mo
- ODE*FDA marketing exclusivity
Mar 13, 2030
in 3 yr 9 mo
- ODE-490Orphan-drug exclusivity (7 years)
Jul 24, 2031
in 5 yr 2 mo
- I-938New indication exclusivity (3 years)
Mar 13, 2027
in 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
- I-938New indication exclusivity (3 years)
Mar 13, 2027
in 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
- I-938New indication exclusivity (3 years)
Mar 13, 2027
in 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
- I-938New indication exclusivity (3 years)
Mar 13, 2027
in 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11260053 | May 26, 2031 | in 5 yr | U-3974 |
| 10512657 | Oct 26, 2032 | in 6 yr 5 mo | U-3850 |
| 11229661 | Oct 26, 2032 | in 6 yr 5 mo | U-3850 |
| 11376251 | Oct 26, 2032 | in 6 yr 5 mo | U-3290 |
| 12350267 | Oct 26, 2032 | in 6 yr 5 mo | U-3973 |
| 11918578 | Feb 12, 2040 | in 13 yr 10 mo | U-3290 |
| 11229647 | Feb 12, 2040 | in 13 yr 10 mo | U-3974 |
| 11497745 | Feb 12, 2040 | in 13 yr 10 mo | U-3974 |
| 12599602 | Feb 12, 2040 | in 13 yr 10 mo | U-3974 |
| 12296050 | Oct 05, 2043 | in 17 yr 7 mo | ProductU-4186 |
Maralixibat chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
