MARALIXIBAT CHLORIDE - Generic Drug Details
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What are the generic drug 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 thirteen patent family members in twenty-one countries.
One supplier is listed for this compound.
Summary for MARALIXIBAT CHLORIDE
International Patents: | 113 |
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 PRURITUS IN PATIENTS 5 YEARS OF AGE AND OLDER 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 | ⤷ 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 | ||||
>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 |
---|---|---|---|
European Patent Office | 3923970 | PROCÉDÉS POUR AUGMENTER LA CROISSANCE CHEZ DES SUJETS PÉDIATRIQUES AYANT UNE MALADIE HÉPATIQUE CHOLESTATIQUE (METHODS FOR INCREASING GROWTH IN PEDIATRIC SUBJECTS HAVING CHOLESTATIC LIVER DISEASE) | ⤷ Sign Up |
South Korea | 20210137466 | 담즙정체성 간 질환을 갖는 소아 대상체에서 성장을 증가시키는 방법 | ⤷ Sign Up |
European Patent Office | 3923943 | RÉPONSE DÉPENDANT DU GÉNOTYPE ET DE LA DOSE À UN ASBTI CHEZ DES PATIENTS AYANT UNE DÉFICIENCE DE POMPE D'EXPORTATION DE SEL BILIAIRE (GENOTYPE AND DOSE-DEPENDENT RESPONSE TO AN ASBTI IN PATIENTS WITH BILE SALT EXPORT PUMP DEFICIENCY) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MARALIXIBAT CHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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