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Livmarli · pharmadog
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This page is a research summary built from public sources (FDA, NIH, clinical trial registries). It is not medical advice. Always talk to your doctor about treatment decisions. Drug information here may be incomplete or out of date — verify with your prescriber and the manufacturer's package insert.
maralixibat chloride Marketed updated 2mo ago by $MIRM Mirum Pharmaceuticals, Inc. 🔗 ChEMBL Approved
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Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 3 investigational indications.
targets Ileal sodium/bile acid cotransporter
all catalysts(0) nothing on the calendar yet
News(0) no news has mentioned this drug yet
generic
maralixibat chloride
MOA
Ileal bile acid transporter inhibitor
indication
Biliary Atresia
Patent cliff source: FDA Orange Book first barrier falls
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (42) Oct 5, 2043 formulation US 12296050 Oct 5, 2043 formulation US 12296050 Oct 5, 2043 formulation US 12296050 Oct 5, 2043 formulation US 12296050 Feb 12, 2040 method-of-use (U-4187) US 11229647 Feb 12, 2040 method-of-use (U-3290) US 11229647 Feb 12, 2040 method-of-use (U-4187) US 11229647 Feb 12, 2040 method-of-use (U-4187) US 11229647 Feb 12, 2040 method-of-use (U-4187) US 11229647 Feb 12, 2040 method-of-use (U-4187) US 11497745 Feb 12, 2040 method-of-use (U-4187) US 11497745 Feb 12, 2040 method-of-use (U-4187) US 11497745 Feb 12, 2040 method-of-use (U-3290) US 11497745 Feb 12, 2040 method-of-use (U-4187) US 11497745 Feb 12, 2040 method-of-use (U-3974) US 11918578 Oct 26, 2032 method-of-use (U-3973) US 10512657 Oct 26, 2032 method-of-use (U-4186) US 10512657 Oct 26, 2032 method-of-use (U-4186) US 10512657 Oct 26, 2032 method-of-use (U-4186) US 10512657 Oct 26, 2032 method-of-use (U-4186) US 10512657 Oct 26, 2032 method-of-use (U-3850) US 10512657 Oct 26, 2032 method-of-use (U-3850) US 11229661 Oct 26, 2032 method-of-use (U-4186) US 11229661 Oct 26, 2032 method-of-use (U-4186) US 11229661 Oct 26, 2032 method-of-use (U-4186) US 11229661 Oct 26, 2032 method-of-use (U-4186) US 11229661 Oct 26, 2032 method-of-use (U-3973) US 11229661 Oct 26, 2032 method-of-use (U-4187) US 11376251 Oct 26, 2032 method-of-use (U-4187) US 11376251 Oct 26, 2032 method-of-use (U-3974) US 11376251 Oct 26, 2032 method-of-use (U-4187) US 11376251 Oct 26, 2032 method-of-use (U-4187) US 11376251 Oct 26, 2032 method-of-use (U-3973) US 12350267 Oct 26, 2032 method-of-use (U-3973) US 12350267 Oct 26, 2032 method-of-use (U-3973) US 12350267 Oct 26, 2032 method-of-use (U-3973) US 12350267 Oct 26, 2032 method-of-use (U-3973) US 12350267 May 26, 2031 method-of-use (U-4187) US 11260053 4.9y May 26, 2031 method-of-use (U-4187) US 11260053 4.9y May 26, 2031 method-of-use (U-3290) US 11260053 4.9y May 26, 2031 method-of-use (U-4187) US 11260053 4.9y May 26, 2031 method-of-use (U-4187) US 11260053 4.9y FDA exclusivities (19) Jul 24, 2031 ODE-490 Orphan Drug (7y) Mar 13, 2031 ODE-471 Orphan Drug (7y) 4.7y Mar 13, 2031 ODE* ODE* 4.7y Mar 13, 2030 ODE* ODE* 3.7y Mar 13, 2030 ODE-429 Orphan Drug (7y) 3.7y Sep 29, 2028 ODE-379 Orphan Drug (7y) 2.2y Sep 29, 2028 Data sources
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ODE*
ODE*
2.2y
Mar 13, 2027 I-938 Indication (3y) 249d
Mar 13, 2027 I-938 Indication (3y) 249d
Mar 13, 2027 I-938 Indication (3y) 249d
Mar 13, 2027 I-938 Indication (3y) 249d
Mar 13, 2027 I-938 Indication (3y) 249d
Sep 29, 2026 NCE New Chemical Entity (5y) 84d
Sep 29, 2026 NCE New Chemical Entity (5y) 84d
Sep 29, 2026 NCE New Chemical Entity (5y) 84d
Sep 29, 2026 NCE New Chemical Entity (5y) 84d
Sep 29, 2026 NCE New Chemical Entity (5y) 84d
Sep 29, 2026 NCE New Chemical Entity (5y) 84d
Mar 13, 2026 NPP New Product (3y) Trials studying maralixibat chloride 
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