Generic Livmarli Availability

Last updated on Apr 10, 2025.

Livmarli is a brand name of maralixibat, approved by the FDA in the following formulation(s):

LIVMARLI (maralixibat chloride - solution;oral)

Manufacturer: MIRUM
Approval date: September 29, 2021
Strength(s): EQ 9.5MG BASE/ML ^[RLD]
Manufacturer: MIRUM
Approval date: July 24, 2024
Strength(s): EQ 19MG BASE/ML ^[RLD]

Is there a generic version of Livmarli available?

No. There is currently no therapeutically equivalent version of Livmarli available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Livmarli. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent 10,512,657
Issued: December 24, 2019
Inventor(s): Gedulin Bronislava & Grey Michael & "ODonnell Niall"
Assignee(s): LUMENA PHARMACEUTIALS LLC
Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- October 26, 2032
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC)
- October 26, 2032
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Methods for treating cholestasis
Patent 11,229,647
Issued: January 25, 2022
Inventor(s): Jaecklin Thomas & Dorenbaum Alejandro
Assignee(s): MIRUM PHARMACEUTICALS, INC.
Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 μg/kg/day.
Patent expiration dates:
- February 12, 2040
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
- February 12, 2040
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent 11,229,661
Issued: January 25, 2022
Inventor(s): Gedulin Bronislava & Grey Michael & "ODonnell Niall"
Assignee(s): SHIRE HUMAN GENETIC THERAPIES, INC.
Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- October 26, 2032
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC)
- October 26, 2032
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Bile acid recycling inhibitors and satiogens for treatment of diabetes, obesity, and inflammatory gastrointestinal conditions
Patent 11,260,053
Issued: March 1, 2022
Inventor(s): Gedulin Bronislava & Young Andrew A. & Greene Howard E.
Assignee(s): SATIOGEN PHARMACEUTICALS, INC.
Provided herein are methods of utilizing bile acid transport inhibitors and/or enteroendocrine peptide enhancing agents for the treatment of obesity, diabetes, and inflammatory gastrointestinal conditions.
Patent expiration dates:
- May 26, 2031
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
- May 26, 2031
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent 11,376,251
Issued: July 5, 2022
Inventor(s): Gedulin; Bronislava et al.
Assignee(s): Shire Human Genetic Therapies, Inc. (Lexington, MA)
Provided herein are methods of treating or ameliorating a pediatric cholestatic liver disease by non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTI) or a pharmaceutically acceptable salt thereof. Also provided are methods for treating or ameliorating a pediatric liver disease, decreasing the levels of serum bile acids or hepatic bile acids, treating or ameliorating pruritis, reducing liver enzymes, or reducing bilirubin comprising non-systemically administering to an individual in need thereof a therapeutically effective amount of a pediatric formulation comprising an ASBTI or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- October 26, 2032
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
- October 26, 2032
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Methods for treating cholestasis
Patent 11,497,745
Issued: November 15, 2022
Inventor(s): Jaecklin; Thomas et al.
Assignee(s): MIRUM PHARMACEUTICALS, INC. (Foster City, CA)
Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 μg/kg/day.
Patent expiration dates:
- February 12, 2040
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
- February 12, 2040
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Methods for treating cholestasis
Patent 11,918,578
Issued: March 5, 2024
Inventor(s): Jaecklin; Thomas et al.
Assignee(s): MIRUM PHARMACEUTICALS, INC. (Foster City, CA)
Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 μg/kg/day.
Patent expiration dates:
- February 12, 2040
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
- February 12, 2040
  ✓
  Patent use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- March 13, 2026 - NEW PATIENT POPULATION
- September 29, 2026 - NEW CHEMICAL ENTITY
- March 13, 2027 - TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
- September 29, 2028 - FOR TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) 1 YEAR OF AGE AND OLDER
- September 29, 2028 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
- March 13, 2030 - TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 1 YEAR OF AGE WITH ALAGILLE SYNDROME (ALGS)
- March 13, 2030 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
- March 13, 2031 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
- March 13, 2031 - TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 5 YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
- July 24, 2031 - TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

More about Livmarli (maralixibat)

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Livmarli drug information

Professional resources

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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