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Last Updated: December 15, 2025

Claims for Patent: 12,311,027

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Summary for Patent: 12,311,027

Title:	Pharmaceutical compositions having improved storage stability
Abstract:	The present invention relates to a pharmaceutical composition that provides long-term stability of a hydrolytically labile antipsychotic agent.
Inventor(s):	Jason M. PERRY, Daniel R. Deaver, Magali B. HICKEY, Julius F. Remenar, Jennifer VANDIVER, Michael J. Palmieri, JR., Zhengzheng Pan
Assignee:	Alkermes Pharma Ireland Ltd
Application Number:	US18/618,311
Patent Claims:	1. A pharmaceutical composition comprising: (a) Compound 1 (b) sorbitan laurate; (c) polysorbate 20; and (d) an aqueous vehicle; wherein the pharmaceutical composition comprises less than 10 parts per million of a hydrolysis product of Compound 1; and wherein the ratio of components (b) to (c) is approximately 5 to 2, by weight. 2. The pharmaceutical composition of claim 1, wherein the hydrolysis product of Compound 1 is: 3. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises: (a) 24-30 weight percent compound I: (b) 0.3-0.4 weight percent sorbitan laurate; (c) about 0.1-0.3 weight percent polysorbate 20; and (d) an aqueous vehicle. 4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises: (a) about 26.6 weight percent compound I: (b) about 0.37 weight percent sorbitan laurate; (c) about 0.15 weight percent polysorbate 20; and (d) an aqueous vehicle. 5. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises: (a) 15-35 weight percent compound I: (b) about 0.2-1 weight percent sorbitan laurate; (c) about 0.1-0.3 weight percent polysorbate 20; and (d) an aqueous vehicle. 6. A method of treating schizophrenia in a subject in need thereof comprising administering to the subject the composition of claim 1. 7. A method of treating schizophrenia in a subject in need thereof comprising administering to the subject the composition of claim 3. 8. A method of treating bipolar disorder in a subject in need thereof comprising administering to the subject the composition of claim 1. 9. A method of treating anxiety in a subject in need thereof comprising administering to the subject the composition of claim 1. 10. A method of treating depression in a subject in need thereof comprising administering to the subject the composition of claim 1. 11. A method of treating autism-related irritability in a subject in need thereof comprising administering to the subject the composition of claim 1. 12. A method of treating acute mania in a subject in need thereof comprising administering to the subject the composition of claim 3. 13. The pharmaceutical composition of claim 3, wherein the hydrolysis product of Compound 1 is: 14. The pharmaceutical composition of claim 4, wherein the hydrolysis product of Compound 1 is: 15. The pharmaceutical composition of claim 5, wherein the hydrolysis product of Compound 1 is:

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