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LIVMARLI

NDA

MARALIXIBAT CHLORIDE | N214662 | MIRUM PHARMACEUTICALS INC

2 strengths9 unique patents8 unique exclusivities

Patent Timeline

9 unique patents, 8 exclusivities by expiration date

Active (9)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Oct. 26, 2032

Feb. 12, 2040

Oct. 26, 2032

May. 26, 2031

Oct. 26, 2032

Feb. 12, 2040

Feb. 12, 2040

Oct. 26, 2032

Feb. 12, 2040

NPP

Mar. 13, 2026

NCE

Sep. 29, 2026

I-938

Mar. 13, 2027

ODE-379

Sep. 29, 2028

ODE-429

Mar. 13, 2030

ODE-471

Mar. 13, 2031

ODE*

Mar. 13, 2031

ODE-490

Jul. 24, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

4 cases on OB patents (4 active) from PACER

Case	Court	Filed	Status	Judge
Mirum Pharmaceuticals, Inc. et al v. Annora Pharma Private Limited et al 1:2025cv01537 8 patentsANDA 220780maralixibat	D. Del.	2025-12-19	Active	—
Mirum Pharmaceuticals, Inc. et al v. Sandoz Inc. 1:2025cv01538 5 patentsANDA 220714maralixibat	D. Del.	2025-12-19	Active	—
Mirum Pharmaceuticals, Inc. et al v. Zenara Pharma Private Limited et al 1:2025cv01539 8 patentsANDA 220917maralixibat	D. Del.	2025-12-19	Active	—
Mirum Pharmaceuticals, Inc. et al v. Zydus Lifesciences Global FZE et al 1:2025cv01541 8 patentsANDA 220669Maralixibat Chloride Solution, Oral	D. Del.	2025-12-19	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Livmarli (2023)

Total Spending

$3.9M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$1776.32

Spending Trend

$1.8M(2022)→$3.9M(2023)

YoY Change:+4.6%

5yr CAGR:+4.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDMARALIXIBAT CHLORIDE

DMF 414962025

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)MARALIXIBAT CHLORIDE

DMF 415162025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMARALIXIBAT CHLORIDE

DMF 418092025

HONOUR LAB LTDMARALIXIBAT CHLORIDE

DMF 422382025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2024	SUPPL -11	View Letter (PDF)
Jul 25, 2024	SUPPL -9	View Letter (PDF)
Jul 25, 2024	SUPPL -10	View Letter (PDF)
Mar 14, 2024	SUPPL -8	View Letter (PDF)
Mar 14, 2024	SUPPL -5	View Letter (PDF)
Mar 14, 2023	SUPPL -4	View Letter (PDF)
Apr 4, 2022	SUPPL -1	View Letter (PDF)
Oct 21, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 9.5MG BASE/ML

RLD

8 patents6 exclusivities▴

SOLUTION;ORAL | Approved: Sep 29, 2021

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10512657	Oct 26, 2032	—	—	—	—
11229647	Feb 12, 2040	—	—	—	—
11229661	Oct 26, 2032	—	—	—	—
11260053	May 26, 2031	—	—	—	—
11376251	Oct 26, 2032	—	—	—	—
11497745	Feb 12, 2040	—	—	—	—
11918578	Feb 12, 2040	—	—	—	—
12599602	Feb 12, 2040	—	—	—	—

Exclusivities (6)

Code	Date	Status
I-938	Mar 13, 2027	< 1 year
NCE	Sep 29, 2026	< 1 year
NPP	Mar 13, 2026	Expired
ODE-379	Sep 29, 2028	Active
ODE-429	Mar 13, 2030	Active
ODE-471	Mar 13, 2031	Active

#002 — EQ 19MG BASE/ML

RLD

3 patents3 exclusivities▾

SOLUTION;ORAL | Approved: Jul 24, 2024

Change History (1)

Recent changes detected for this application.

MODIFIEDExclusivity Expiration7/1/2026

Old: Sep 29, 2028

New: Mar 13, 2031