LIVMARLI Drug Patent Profile
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Which patents cover Livmarli, and what generic alternatives are available?
Livmarli is a drug marketed by Mirum and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and fourteen patent family members in twenty-two countries.
The generic ingredient in LIVMARLI is maralixibat chloride. One supplier is listed for this compound. Additional details are available on the maralixibat chloride profile page.
DrugPatentWatch® Generic Entry Outlook for Livmarli
Livmarli will be eligible for patent challenges on September 29, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 24, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for LIVMARLI
| International Patents: | 114 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 16 |
| Patent Applications: | 51 |
| Drug Prices: | Drug price information for LIVMARLI |
| What excipients (inactive ingredients) are in LIVMARLI? | LIVMARLI excipients list |
| DailyMed Link: | LIVMARLI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LIVMARLI
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for LIVMARLI
US Patents and Regulatory Information for LIVMARLI
LIVMARLI is protected by fourteen US patents and ten FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LIVMARLI is ⤷ Sign Up.
This potential generic entry date is based on TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC).
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting LIVMARLI
Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC)
Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Methods for treating cholestasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Methods for treating cholestasis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTATIS (PFIC)
Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented 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 Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Bile acid recycling inhibitors and satiogens for treatment of diabetes, obesity, and inflammatory gastrointestinal conditions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS)
FDA Regulatory Exclusivity protecting LIVMARLI
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 1 YEAR OF AGE WITH ALAGILLE SYNDROME (ALGS)
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS FIVE YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Exclusivity Expiration: ⤷ Sign Up
FOR TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) 1 YEAR OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 5 YEARS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Exclusivity Expiration: ⤷ Sign Up
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 SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up
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 SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up
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 SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-001 | Sep 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-001 | Sep 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-002 | Jul 24, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-001 | Sep 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-001 | Sep 29, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-002 | Jul 24, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-002 | Jul 24, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for LIVMARLI
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mirum Pharmaceuticals International B.V. | Livmarli | Maralixibat chloride | EMEA/H/C/005857 Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older. |
Authorised | no | no | yes | 2022-12-09 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for LIVMARLI
See the table below for patents covering LIVMARLI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 112014010223 | inibidores de reciclagem de ácido de bílis para o tratamento de doenças hepáticas colestáticas pediatras | ⤷ Sign Up |
| Spain | 2633766 | ⤷ Sign Up | |
| Mexico | 363161 | INHIBIDORES DE LA RECIRCULACIÓN DE ÁCIDOS BILIARES PARA EL TRATAMIENTO DE HIPERCOLEMIA Y ENFERMEDAD HEPÁTICA COLESTÁSICA. (BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF HYPERCHOLEMIA AND CHOLESTATIC LIVER DISEASE.) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2020167981 | ⤷ Sign Up | |
| Singapore | 10201909122Q | BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF PEDIATRIC CHOLESTATIC LIVER DISEASES | ⤷ Sign Up |
| Mexico | 2021009622 | METODOS PARA TRATAR LA COLESTASIS. (METHODS FOR TREATING CHOLESTASIS.) | ⤷ Sign Up |
| European Patent Office | 4137137 | INHIBITEURS ET SATIOGÈNES DE RECYCLAGE D'ACIDE BILIAIRE POUR LE TRAITEMENT DU DIABÈTE, DE L'OBÉSITÉ ET D'ÉTATS GASTRO-INTESTINAUX INFLAMMATOIRES (BILE ACID RECYCLING INHIBITORS AND SATIOGENS FOR TREATMENT OF DIABETES, OBESITY, AND INFLAMMATORY GASTROINTESTINAL CONDITIONS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LIVMARLI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2771003 | CR 2023 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212 |
| 2771003 | 301234 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MARALIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MARALIXIBATCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1704 20221212 |
| 2771003 | 21/2023 | Austria | ⤷ Sign Up | PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 (MITTEILUNG) 20221212 |
| 2771003 | CA 2023 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212 |
| 2771003 | 2023C/521 | Belgium | ⤷ Sign Up | PRODUCT NAME: MARALIXIBAT, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORURE DE MARALIXIBAT; AUTHORISATION NUMBER AND DATE: EU/1/22/1704 20221212 |
| 2771003 | 122023000029 | Germany | ⤷ Sign Up | PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 20221209 |
| 2771003 | 23C1022 | France | ⤷ Sign Up | PRODUCT NAME: MARALIXIBAT, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE MARALIXIBAT, EN PARTICULIER LE CHLORURE DE MARALIXIBAT; REGISTRATION NO/DATE: EU/1/22/1704 20221212 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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