# US 11,433,050 B2 · Treatment for primary biliary cholangitis

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- Number: US 11,433,050 B2
- Document ID: US11433050B2
- Status: Granted
- Kind: B2
- Application number: 17/512,950
- Filed: 2021-10-28
- Published: 2022-03-03
- Granted: 2022-09-06
- Earliest claimed: 2016-12-09
- Assignees: Cadila Healthcare Limited
- Applicants: Cadila Healthcare Ltd.
- Inventors: Mukul R. Jain; Deven V. Parmar; Suresh Giri; Binu Philip; Pankaj Patel
- Web page: https://patentgrep.com/patent/US11433050B2

## CPC

- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/575: substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention provides therapeutic compound for prevention and treatment of primary biliary cholangitis, (PBC). Specifically, the present invention provides pharmaceutical composition comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, for the treatment of PBC.

## Claims

### Claim 1

A method of treating primary biliary cholangitis, comprising administering orally and once daily to a human in need thereof about 2 mg or about 4 mg of saroglitazar magnesium salt, to treat the primary biliary cholangitis; wherein saroglitazar is represented by:

### Claim 2 (depends on 1)

The method of claim 1, wherein about 4 mg saroglitazar magnesium salt is administered.

### Claim 3 (depends on 1)

The method of claim 1, wherein about 2 mg saroglitazar magnesium salt is administered.

### Claim 4 (depends on 1)

The method of claim 1, wherein saroglitazar magnesium salt is the sole therapeutic agent for treating the primary biliary cholangitis.

### Claim 5 (depends on 1)

The method of claim 1, wherein administering occurs for at least 16 weeks.

### Claim 6

A method of treating primary biliary cholangitis, comprising administering orally and once daily to a human in need thereof a pharmaceutical formulation in the form of a tablet or a capsule, the pharmaceutical formulation comprising about 2 mg or about 4 mg of saroglitazar magnesium salt; and a pharmaceutical excipient, to treat the primary biliary cholangitis; wherein saroglitazar is represented by:

### Claim 7 (depends on 6)

The method of claim 6, wherein saroglitazar magnesium salt is the sole therapeutic agent in the pharmaceutical formulation.

### Claim 8 (depends on 6)

The method of claim 6, wherein saroglitazar magnesium salt is the sole therapeutic agent for treating the primary biliary cholangitis.

### Claim 9 (depends on 6)

The method of claim 6, wherein the pharmaceutical formulation comprises about 2 mg saroglitazar magnesium salt.

### Claim 10 (depends on 6)

The method of claim 6, wherein the pharmaceutical formulation comprises about 4 mg saroglitazar magnesium salt.