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Last Updated: December 17, 2025

Claims for Patent: 12,329,742

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Summary for Patent: 12,329,742

Title:	Pharmaceutical composition of darolutamide
Abstract:	The present invention relates to a pharmaceutical composition for oral administration, particularly in the form of a tablet, comprising darolutamide or a pharmaceutically acceptable salt thereof as an active ingredient. Darolutamide is a potent androgen receptor (AR) modulator useful in the treatment of cancer, particularly AR dependent cancer such as prostate cancer, and other diseases where AR antagonism is desired.
Inventor(s):	Susanna ILMONEN, Juha LINTUNEN, Petteri LYYTINEN, Marko Saalasti
Assignee:	Orion Oyj
Application Number:	US17/623,922
Patent Claims:	1. A pharmaceutical composition comprising (a) at least 45-80%, per weight of the composition, of darolutamide or a pharmaceutically acceptable salt thereof; (b) 7-20%, per weight of the composition, of calcium hydrogen phosphate; (c) 25-35%, per weight of the composition, of lactose; (d) 0.5-10%, per weight of the composition, of a disintegrant; (e) 0.5-10%, per weight of the composition, of a binder; and (f) 0.2-5%, per weight of the composition, of a lubricant; wherein the composition is in the form of a tablet. 2. The pharmaceutical composition according to claim 1, wherein the disintegrant is croscarmellose sodium; the binder is polyvinylpyrrolidone; and the lubricant is magnesium stearate. 3. The pharmaceutical composition according to claim 1, wherein darolutamide or a pharmaceutically acceptable salt thereof is present in an amount of 300 mg or 600 mg. 4. The pharmaceutical composition according to claim 2, wherein darolutamide or a pharmaceutically acceptable salt thereof is present in an amount of 300 mg or 600 mg. 5. The pharmaceutical composition according to claim 2, comprising a tablet core and a film coating, wherein the tablet core comprises: (a) about 300 mg of darolutamide or a pharmaceutically acceptable salt thereof; (b) about 60 mg of calcium hydrogen phosphate; (c) about 180 mg of lactose monohydrate; (d) about 30 mg of croscarmellose sodium; (e) about 24 mg of polyvinylpyrrolidone; and (f) about 5.4 of magnesium stearate. 6. The pharmaceutical composition according to claim 1, wherein darolutamide or a pharmaceutically acceptable salt thereof is in a crystalline form.

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