FDA Orange Book
Is there a generic for Livmarli?
Livmarli contains maralixibat chloride. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Livmarli (maralixibat chloride). The Orange Book shows its last listed patent expires October 5, 2043 and its last listed exclusivity ends July 24, 2031.
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Livmarli products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 19MG BASE/ML | Marketed (Rx) | None | 0 | None |
| solution, oral | EQ 9.5MG BASE/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 15MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 30MG BASE | Marketed (Rx) | None | 0 | None |
NDA 214662, 219485, held by MIRUM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Livmarli patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11260053 | May 26, 2031 | Method of use | U-3974 | 214662 |
| 11260053 | May 26, 2031 | Method of use | U-3290 | 214662 |
| 11260053 | May 26, 2031 | Method of use | U-4187 | 219485 |
| 10512657 | October 26, 2032 | Method of use | U-3850 | 214662 |
| 11229661 | October 26, 2032 | Method of use | U-3850 | 214662 |
| 11376251 | October 26, 2032 | Method of use | U-3290 | 214662 |
| 11376251 | October 26, 2032 | Method of use | U-3974 | 214662 |
| 12350267 | October 26, 2032 | Method of use | U-3973 | 214662 |
| 11229661 | October 26, 2032 | Method of use | U-3973 | 214662 |
| 10512657 | October 26, 2032 | Method of use | U-3973 | 214662 |
| 11376251 | October 26, 2032 | Method of use | U-4187 | 219485 |
| 11229661 | October 26, 2032 | Method of use | U-4186 | 219485 |
| 10512657 | October 26, 2032 | Method of use | U-4186 | 219485 |
| 11918578 | February 12, 2040 | Method of use | U-3290 | 214662 |
| 11229647 | February 12, 2040 | Method of use | U-3974 | 214662 |
| 11918578 | February 12, 2040 | Method of use | U-3974 | 214662 |
| 11497745 | February 12, 2040 | Method of use | U-3974 | 214662 |
| 11229647 | February 12, 2040 | Method of use | U-3290 | 214662 |
| 11497745 | February 12, 2040 | Method of use | U-3290 | 214662 |
| 12599602 | February 12, 2040 | Method of use | U-3974 | 214662 |
| 12599602 | February 12, 2040 | Method of use | U-3290 | 214662 |
| 11497745 | February 12, 2040 | Method of use | U-4187 | 219485 |
| 11229647 | February 12, 2040 | Method of use | U-4187 | 219485 |
| 12296050 | October 5, 2043 | Drug product | U-4186 | 219485 |
| 12296050 | October 5, 2043 | Drug product | U-4187 | 219485 |
Livmarli exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | March 13, 2026 | 214662 |
| NCE | New chemical entity | September 29, 2026 | 214662 |
| I-938 | New indication | March 13, 2027 | 214662 |
| ODE-379 | Orphan drug exclusivity | September 29, 2028 | 214662 |
| ODE* | See the Orange Book exclusivity code list | September 29, 2028 | 214662 |
| ODE-429 | Orphan drug exclusivity | March 13, 2030 | 214662 |
| ODE* | See the Orange Book exclusivity code list | March 13, 2030 | 214662 |
| ODE-471 | Orphan drug exclusivity | March 13, 2031 | 214662 |
| ODE* | See the Orange Book exclusivity code list | March 13, 2031 | 214662 |
| ODE-490 | Orphan drug exclusivity | July 24, 2031 | 214662 |
Livmarli NDC codes
Questions
Is there a generic for Livmarli?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Livmarli (maralixibat chloride). The Orange Book shows its last listed patent expires October 5, 2043 and its last listed exclusivity ends July 24, 2031.
What is the generic name for Livmarli?
The active ingredient in Livmarli is maralixibat chloride, per the FDA Orange Book.
When does the Livmarli patent expire?
The last patent listed for Livmarli in the Orange Book expires October 5, 2043. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.