IP Library Granted Patent US 12,178,799
Granted Patent B2
US 12,178,799 · App. 17/880,949 · Granted Dec 31, 2024

Treatment for primary biliary cholangitis

Inventors: Mukul R. Jain (Gujarat, IN); Deven V. Parmar (Gujarat, IN); Suresh Giri (Gujarat, IN); Binu Philip (Gujarat, IN); Pankaj Patel (Gujarat, IN)
Assignee: Zydus Lifesciences Limited
A61K31/40A61K9/0053A61K31/575A61P1/16
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Quick Facts
Patent No.
US 12,178,799
App. No.
17/880,949
Granted
Dec 31, 2024
Kind
B2
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 (10)

1. A method of treating primary biliary cholangitis, comprising administering orally and once daily to a human in need thereof a therapeutically effective amount of saroglitazar magnesium salt, to treat the primary biliary cholangitis; wherein saroglitazar is represented by:

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

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

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

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

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 a therapeutically effective amount of saroglitazar magnesium salt; and a pharmaceutical excipient, to treat the primary biliary cholangitis; wherein saroglitazar is represented by:

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

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

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

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

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2023
From: JAIN, MUKUL; PARMAR, DEVEN V.; GIRI, SURESH; PHILIP, BINU; PATEL, PANKAJ
To: CADILA HEALTHCARE LIMITED
Reel/Frame 065008/0788 →
CHANGE OF NAME Recorded Sep 25, 2023
From: CADILA HEALTHCARE LIMITED
To: ZYDUS LIFESCIENCES LIMITED
Reel/Frame 065008/0795 →
Priority Claims (1)
IN 201621042122 · Dec 9, 2016 · national
Continuity (4)
Continuation 17512950 · Oct 28, 2021
Continuation 16919404 · Jul 2, 2020
Continuation 15835938 · Dec 8, 2017
Related Publication 20230201162A1 · Jun 29, 2023