Orange Book product · Brand (NDA)
LIVMARLI
MARALIXIBAT CHLORIDE
At a glance
Apr 10, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 10, 2025
1 yr 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
Patent 11260053 expires
Listed method-of-use patent (U-4187) expiration.
May 26, 2031
in 5 yr
Patent 10512657 expires
Listed method-of-use patent (U-4186) expiration.
Oct 26, 2032
in 6 yr 5 mo
Patent 11229661 expires
Listed method-of-use patent (U-4186) expiration.
Oct 26, 2032
in 6 yr 5 mo
Patent 11376251 expires
Listed method-of-use patent (U-4187) expiration.
Oct 26, 2032
in 6 yr 5 mo
Patent 12350267 expires
Listed method-of-use patent (U-3973) expiration.
Oct 26, 2032
in 6 yr 5 mo
Patent 11229647 expires
Listed method-of-use patent (U-4187) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 11497745 expires
Listed method-of-use patent (U-4187) expiration.
Feb 12, 2040
in 13 yr 10 mo
Patent 12296050 expires
Listed drug product patent expiration.
Oct 05, 2043
in 17 yr 7 mo
Patent 12296050 expires
Listed drug product patent expiration.
Oct 05, 2043
in 17 yr 7 mo
Pharmaceutical detail
Active ingredient
MARALIXIBAT CHLORIDE
Strength
EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219485
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (2)
- NCENew chemical entity exclusivity (5 years)
Sep 29, 2026
in 3 mo
- I-938New indication exclusivity (3 years)
Mar 13, 2027
in 9 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11260053 | May 26, 2031 | in 5 yr | U-4187 |
| 10512657 | Oct 26, 2032 | in 6 yr 5 mo | U-4186 |
| 11229661 | Oct 26, 2032 | in 6 yr 5 mo | U-4186 |
| 11376251 | Oct 26, 2032 | in 6 yr 5 mo | U-4187 |
| 12350267 | Oct 26, 2032 | in 6 yr 5 mo | U-3973 |
| 11229647 | Feb 12, 2040 | in 13 yr 10 mo | U-4187 |
| 11497745 | Feb 12, 2040 | in 13 yr 10 mo | U-4187 |
| 12296050 | Oct 05, 2043 | in 17 yr 7 mo | ProductU-4186 |
| 12296050 | Oct 05, 2043 | in 17 yr 7 mo | ProductU-4187 |

