Viewing data from:

ACTIGALL

NDA

URSODIOL | N019594 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pharmobedient Consulting, LLC FDA-2025-P-0184 Pharmobedient Consulting, LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether the Reference Listed Drug ACTIGALL (Ursodiol) Capsules, 150 mg, approved under NDA 019594 and held by Teva Branded Pharmaceutical Produ	505(q)	2025-01-16	Withdrawn	Pharmobedient Consulting

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

6 trials from ClinicalTrials.gov — 3 recruiting, 3 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.NCT06383403	Phase 3	Active	Ipsen	69	2024-07-09 → 2026-06-26
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)NCT04526665	Phase 3	Active	Ipsen	161	2020-09-24 → 2028-12-01
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.NCT06247735	Phase 2	Active	Kowa Research Institute, Inc.	46	2024-02-07 → 2026-07
Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients.NCT07664020	N/A	Not Yet Recruiting	Institute of Liver and Biliary Sciences, India	130	2026-06-18 → 2027-11-01
Perioperative Ursodeoxycholic Acid for Renal Protection in Adults Undergoing Partial Nephrectomy for Renal Tumors NCT07672860	Phase 2	Recruiting	Jinling Hospital, China	146	2026-06-01 → 2027-12
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance NCT06684106	N/A	Recruiting	First Affiliated Hospital Xi'an Jiaotong University	128	2024-11-25 → 2027-06-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Reltone (2023)

Total Spending

$560K

Total Claims

257

Beneficiaries

110

Avg Cost/Unit

$23.00

Spending Trend

$239K(2019)→$238K(2020)→$274K(2021)→$200K(2021)→$189K(2022)→$1.0M(2022)→$560K(2023)→$157K(2023)

YoY Change:-1.1%

5yr CAGR:-4.9%

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

API Supply Chain12 active DMFs2 inactive

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

ICE SPAURSODIOL

DMF 168032003

DAEWOONG BIO INCURSODIOL USP (PROCESS I)

DMF 255362011

DAEWOONG BIO INCURSODIOL USP (PROCESS IV)

DMF 289942015

ALIVUS LIFE SCIENCES LTDURSODIOL USP

DMF 319872017

ARCH PHARMALABS LTDURSODIOL USP

DMF 334102018

ZHONGSHAN BELLING BIOTECHNOLOGY CO LTDURSODIOL

DMF 349372020

MACLEODS PHARMACEUTICALS LTDURSODIOL USP

DMF 393462024

SICHUAN ELIXIR PHARMACEUTICAL CO LTDURSODIOL

DMF 396472024

SYMBIO GENERRICS INDIA PRIVATE LTDURSODIOL

DMF 405482025

PHARMAZELL GMBHURSODIOL

DMF 406262024

SICHUAN XIELI PHARMACEUTICAL CO LTDURSODIOL

DMF 416172025

SHILPA PHARMA LIFESCIENCES LTDURSODIOL USP

DMF 420552025

AXCAN PHARMA INCInactiveURSODIOL SUSPENSION, 250 MG/ML

DMF 177172004

DAEWOONG BIO INCInactiveURSODIOL USP (URSODEOXYCHOLIC ACID)

DMF 214342008

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 20, 2023	SUPPL -37	View Letter (PDF)
Aug 14, 2002	SUPPL -21	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 31, 1987

No patent or exclusivity listings for this strength.

#002 — 300MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 31, 1987