Livmarli - (9.5 mg/mL ; Oral Solution)

Generic Name	Maralixibat Chloride	Innovator	Mirum Pharmaceutical
Dosage	9.5 mg/mL ; Oral Solution	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events

Livmarli - (19 mg/mL ; Oral Solution)

Generic Name	Maralixibat Chloride	Innovator	Mirum Pharmaceutical
Dosage	19 mg/mL ; Oral Solution	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
****** ******	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
****** ******	*** \ *********	*** **, ****	*******	****	*** ****** *** ****

Chronology Of Events