Maralixibat chloride - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for maralixibat chloride and what is the scope of patent protection?
Maralixibat chloride
is the generic ingredient in one branded drug marketed by Mirum and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Maralixibat chloride has one hundred and fourteen patent family members in twenty-two countries.
One supplier is listed for this compound.
Summary for maralixibat chloride
International Patents: | 114 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 16 |
Clinical Trials: | 2 |
Patent Applications: | 47 |
What excipients (inactive ingredients) are in maralixibat chloride? | maralixibat chloride excipients list |
DailyMed Link: | maralixibat chloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for maralixibat chloride
Generic Entry Date for maralixibat chloride*:
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) 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.
Recent Clinical Trials for maralixibat chloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Takeda | Phase 3 |
Pharmacology for maralixibat chloride
Drug Class | Ileal Bile Acid Transporter Inhibitor |
Mechanism of Action | Ileal Bile Acid Transporter Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for maralixibat chloride
US Patents and Regulatory Information for maralixibat chloride
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 | 214662-002 | 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 | ||||
>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 maralixibat chloride
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 maralixibat chloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 2023023 | ⤷ Subscribe | |
World Intellectual Property Organization (WIPO) | 2013063512 | ⤷ Subscribe | |
World Intellectual Property Organization (WIPO) | 2020167981 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for maralixibat chloride
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Maralixibat chloride Market Analysis and Financial Projection Experimental
More… ↓
Make Better Decisions: Try a trial or see plans & pricing
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.