Viewing data from:

CHOLBAM

NDA

CHOLIC ACID | N205750 | MIRUM PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 Cholbam (2023)

Total Spending

$4.5M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$838.30

Spending Trend

$533K(2019)→$2.7M(2020)→$3.4M(2021)→$3.6M(2022)→$4.5M(2023)

YoY Change:-7.4%

5yr CAGR:+6.3%

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

API Supply Chain3 active DMFs1 inactive

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

NEW ZEALAND PHARMACEUTICALS LTDCHOLIC ACID

DMF 271812013

PHARMAZELL GMBHCHOLIC ACID

DMF 417902025

STHREE CHEMICALS PRIVATE LTDCHOLIC ACID

DMF 427982025

SIGMA F AND D DIV LTDInactiveCHOLIC ACID SODIUM SALT

DMF 28431977

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 21, 2026	SUPPL -5	View Letter (PDF)
Oct 23, 2020	SUPPL -3	View Letter (PDF)
Mar 18, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 17, 2015

No patent or exclusivity listings for this strength.

#002 — 250MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 17, 2015