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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Questions you can ask:
- What is the 5 year forecast for LIVMARLI?
- What are the global sales for LIVMARLI?
- What is Average Wholesale Price for LIVMARLI?
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: | 52 |
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
Generic Entry Date for LIVMARLI*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CHOLESTATIC PRURITAS IN PATIENTS 12 MONTHS OF AGE TO LESS THAN 5 YEARS OF AGE WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) NDA:
Dosage:
SOLUTION;ORAL |
*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 ⤷ Subscribe.
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.
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-001 | Sep 29, 2021 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-002 | Jul 24, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-001 | Sep 29, 2021 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-001 | Sep 29, 2021 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Mirum | LIVMARLI | maralixibat chloride | SOLUTION;ORAL | 214662-002 | Jul 24, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 |
---|---|---|---|
Norway | 2023023 | ⤷ Subscribe | |
World Intellectual Property Organization (WIPO) | 2013063512 | ⤷ Subscribe | |
World Intellectual Property Organization (WIPO) | 2020167981 | ⤷ Subscribe | |
Brazil | 112021015815 | Métodos para tratar colestase | ⤷ Subscribe |
South Africa | 201403367 | BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF HYPERCHOLEMIA AND CHOLESTATIC LIVER DISEASE | ⤷ Subscribe |
Eurasian Patent Organization | 029581 | ПРИМЕНЕНИЕ ИНГИБИТОРОВ РЕЦИРКУЛЯЦИИ ЖЕЛЧНЫХ КИСЛОТ ДЛЯ ЛЕЧЕНИЯ ХОЛЕСТАТИЧЕСКОГО ЗАБОЛЕВАНИЯ ПЕЧЕНИ ИЛИ ПРУРИТА (USE OF BILE ACID RECYCLING INHIBITORS FOR TREATMENT OF CHOLESTATIC LIVER DISEASE OR PRURITIS) | ⤷ Subscribe |
>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 | ⤷ Subscribe | PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212 |
2771003 | 301234 | Netherlands | ⤷ Subscribe | PRODUCT NAME: MARALIXIBAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MARALIXIBATCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1704 20221212 |
2771003 | CA 2023 00017 | Denmark | ⤷ Subscribe | PRODUCT NAME: MARALIXIBAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MARALIXIBATCHLORID; REG. NO/DATE: EU/1/22/1704 20221212 |
2771003 | 2023C/521 | Belgium | ⤷ Subscribe | 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 | 21/2023 | Austria | ⤷ Subscribe | PRODUCT NAME: MARALIXIBAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MARALIXIBATCHLORID; REGISTRATION NO/DATE: EU/1/22/1704 (MITTEILUNG) 20221212 |
2771003 | 2390017-8 | Sweden | ⤷ Subscribe | PRODUCT NAME: MARALIXIBAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MARALIXIBAT CHLORIDE; REG. NO/DATE: EU/1/22/1704 20221212 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
LIVMARLI Market Analysis and Financial Projection Experimental
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