Orange Book product · Brand (NDA)
LIVMARLI
MARALIXIBAT CHLORIDE
At a glance
Sep 29, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 29, 2021
4 yr 9 mo ago
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Mar 13, 2026
3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
Exclusivity ends · I-938
New indication exclusivity (3 years)
Mar 13, 2027
in 9 mo
Exclusivity ends · ODE-379
Orphan-drug exclusivity (7 years)
Sep 29, 2028
in 2 yr 4 mo
Exclusivity ends · ODE-429
Orphan-drug exclusivity (7 years)
Mar 13, 2030
in 3 yr 9 mo
Exclusivity ends · ODE-471
Orphan-drug exclusivity (7 years)
Mar 13, 2031
in 4 yr 10 mo
Patent 11260053 expires
Listed method-of-use patent (U-3974) expiration.
May 26, 2031
in 5 yr
Patent 11260053 expires
Listed method-of-use patent (U-3290) expiration.
May 26, 2031
in 5 yr
Patent 10512657 expires
Listed method-of-use patent (U-3850) expiration.
Oct 26, 2032
in 6 yr 5 mo
Patent 11229661 expires
Listed method-of-use patent (U-3850) expiration.
Oct 26, 2032
in 6 yr 5 mo
Patent 11376251 expires
Listed method-of-use patent (U-3290) expiration.
Oct 26, 2032
in 6 yr 5 mo
Patent 11376251 expires
Listed method-of-use patent (U-3974) expiration.
Oct 26, 2032
in 6 yr 5 mo
Patent 11229647 expires
Listed method-of-use patent (U-3974) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 11229647 expires
Listed method-of-use patent (U-3290) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 11497745 expires
Listed method-of-use patent (U-3974) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 11497745 expires
Listed method-of-use patent (U-3290) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 11918578 expires
Listed method-of-use patent (U-3290) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 11918578 expires
Listed method-of-use patent (U-3974) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 12599602 expires
Listed method-of-use patent (U-3974) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 12599602 expires
Listed method-of-use patent (U-3290) expiration.
Feb 12, 2040
in 13 yr 10 mo
Pharmaceutical detail
Active ingredient
MARALIXIBAT CHLORIDE
Strength
EQ 9.5MG BASE/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 214662
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (6)
- NPPNew patient population exclusivity (3 years)
Mar 13, 2026
3 mo ago
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
- I-938New indication exclusivity (3 years)
Mar 13, 2027
in 9 mo
- 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
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11260053 | May 26, 2031 | in 5 yr | U-3974 |
| 11260053 | May 26, 2031 | in 5 yr | U-3290 |
| 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 |
| 11376251 | Oct 26, 2032 | in 6 yr 5 mo | U-3974 |
| 11229647 | Feb 12, 2040 | in 13 yr 10 mo | U-3974 |
| 11229647 | Feb 12, 2040 | in 13 yr 10 mo | U-3290 |
| 11497745 | Feb 12, 2040 | in 13 yr 10 mo | U-3974 |
| 11497745 | Feb 12, 2040 | in 13 yr 10 mo | U-3290 |
| 11918578 | Feb 12, 2040 | in 13 yr 10 mo | U-3290 |
| 11918578 | Feb 12, 2040 | in 13 yr 10 mo | U-3974 |
| 12599602 | Feb 12, 2040 | in 13 yr 10 mo | U-3974 |
| 12599602 | Feb 12, 2040 | in 13 yr 10 mo | U-3290 |
