US 12447128

US Patent 12447128B2, titled "Formulations of enzalutamide," was issued on October 21, 2025, from an application filed on November 11, 2022. The patent is currently assigned to Astellas Pharma Inc and Medivation Prostate Therapeutics LLC. The inventors are Douglas Alan Lorenz, Sanjay Konagurthu, Randy J. Wald, Jason A. Everett, Sheila Matz, Yuuki Takaishi, Toshiro Sakai, Ryousuke Irie, Shinsuke Oba, Hiroyasu Toyota, Koji Nishimura, and Atsushi Kanbayashi.

Abstract:
The patent describes solid formulations of enzalutamide, specifically focusing on pharmaceutical compositions that include amorphous enzalutamide within a solid dispersion with at least one polymer. The disclosure also covers methods for manufacturing these formulations and compositions, and their intended use.

Overview of Independent Claims:

• Independent Claim 1: This claim describes a pharmaceutical composition containing a solid dispersion. The solid dispersion comprises enzalutamide and at least one polymer, where the enzalutamide is at least 60% amorphous. When this composition is given orally to a group of 24 or more humans at a 160 mg dose, it must result in a mean area under the plasma enzalutamide concentration-time curve (AUC 0-7 days) greater than 150 µg·hr/ml. Additionally, the solid dispersion must contain less than 30% by weight of lipophilic microphase-forming materials.
• Independent Claim 11: This claim outlines a manufacturing method for a solid dispersion containing enzalutamide and at least one polymer. The method involves dissolving both enzalutamide and the polymer(s) in a common solvent to create a solution, then using spray drying to remove the solvent, thus forming the solid dispersion. The resulting enzalutamide in the solid dispersion must be at least 60% amorphous, and the solid dispersion must contain less than 30% by weight of lipophilic microphase-forming materials.
• Independent Claim 17: Similar to Claim 1, this claim describes a pharmaceutical composition with a solid dispersion of at least 60% amorphous enzalutamide and at least one polymer. This composition, when administered orally to a cohort of 24 or more humans at a 160 mg dose, must achieve a mean maximum plasma enzalutamide concentration (Cmax) greater than 2 µg/ml. The solid dispersion also has the same limitation of containing less than 30% by weight of lipophilic microphase-forming materials.

Litigation Search:
A direct search of the CAFC 2026 dockets for patent number US12447128B2 did not immediately return specific case filings or scheduled cases directly mentioning this patent. However, the Google Patents information for US12447128B2 indicates that its "Family has litigation" and notes that the "First worldwide family litigation filed" occurred, with a link to a Darts-ip.com entry for family 49231627. The current status of the patent is "Active," with an anticipated expiration date of September 11, 2033.