US 12161628

Summary of U.S. Patent No. 12,161,628

Title: Combination therapy

Assignee: Astellas Pharma Inc., Medivation Prostate Therapeutics LLC

Inventors: Jacqueline GIBBONS, Joyce MORDENTI, Michiel DE VRIES, Walter KRAUWINKEL, Taoufik Ouatas

Filing Date: October 4, 2022

Issue Date: December 10, 2024

Abstract: This disclosure provides a dosage regimen for co-administration of enzalutamide and a strong CYP3A4 inducer.

Independent Claims Overview

The patent contains one independent claim, Claim 1. The subsequent claims (2-6) are dependent on Claim 1, narrowing its scope.

Claim 1: Plain-Language Overview

Claim 1 of patent 12,161,628 describes a method for treating prostate cancer. The method applies to a patient who is already being treated with a drug called rifampin. The core of the patented method is to also give this patient a daily dose of 240 mg of another drug, enzalutamide. In essence, the invention is the specific use of a 240 mg daily dose of enzalutamide in prostate cancer patients who are also taking rifampin.

Litigation Status

As of early 2026, U.S. Patent 12,161,628 has been the subject of litigation. Court records indicate its involvement in a case in the U.S. District Court for the District of New Jersey: Astellas Pharma Inc. v. Hikma Pharms. USA Inc., 25-0578 (D.N.J.). The records show that the claims and counterclaims in this case were dismissed with prejudice, with each party bearing its own costs. A search of the U.S. Court of Appeals for the Federal Circuit (CAFC) dockets for 2026 did not yield specific results for this patent number, though district court decisions are often appealed to the CAFC.