Claims for Patent: 10,525,057

Summary for Patent: 10,525,057

Title:	Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Abstract:	The disclosed embodiments relate to methods of initiating aripiprazole treatment in a patient who is a CYP2D6 poor metabolizer or a CYP3A4 poor metabolizer, or both.
Inventor(s):	Raoufinia; Arash (Vienna, VA)
Assignee:	Otsuka Pharmaceutical Co., Ltd. (Rockville, MD)
Application Number:	14/034,727
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,525,057
Patent Claims:	1. A method of initiating systemic aripiprazole treatment in a patient, comprising initially intramuscularly administering to the patient 66% to 75% of a 300 or 400 mg weight equivalent dose of aripiprazole in the form of a long-acting drug-containing suspension which systemically releases aripiprazole, wherein the dose is released over a period of about one month, and wherein the patient is a CYP2D6 and CYP3A4 extensive metabolizer and is concomitantly administered a strong CYP2D6 inhibitor or a strong CYP3A4 inhibitor. 2. The method of claim 1, wherein 66% to 75% of a 300 mg weight equivalent dose of aripiprazole is administered. 3. The method of claim 1, wherein 66% of a 300 mg weight equivalent dose of aripiprazole is administered. 4. The method of claim 1, wherein 66% to 75% of a 400 mg weight equivalent dose of aripiprazole is administered. 5. The method of claim 1, wherein 75% of a 400 mg weight equivalent dose of aripiprazole is administered. 6. The method of claim 1, wherein the long-acting drug-containing suspension comprises a prodrug of aripiprazole. 7. The method of claim 1, wherein the long-acting drug-containing suspension comprises aripiprazole. 8. The method of claim 6, wherein the long-acting drug-containing suspension comprises (7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquin- olin-1(2H)-yl)methyl dodecanoate. 9. A method of initiating systemic aripiprazole treatment in a patient, comprising initially intramuscularly administering to the patient 75% of a 300 or 400 mg weight equivalent dose of aripiprazole in the form of a long-acting drug-containing suspension which systemically releases aripiprazole, wherein the dose is released over a period of about one month, and wherein the patient is a CYP2D6 poor metabolizer not concomitantly administered a strong CYP3A4 inhibitor or a strong CYP2D6 inhibitor. 10. The method of claim 9, wherein 75% of a 300 mg weight equivalent dose of aripiprazole is administered. 11. The method of claim 9, wherein 75% of a 400 mg weight equivalent dose of aripiprazole is administered. 12. The method of claim 9, wherein the long-acting drug-containing suspension comprises a prodrug of aripiprazole. 13. The method of claim 9, wherein the long-acting drug-containing suspension comprises aripiprazole. 14. The method of claim 12, wherein the long-acting drug-containing suspension comprises (7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquin- olin-1(2H)-yl)methyl dodecanoate. 15. A method of initiating systemic aripiprazole treatment in a patient, comprising initially intramuscularly administering to the patient 53% of a 300 mg or 50% of a 400 mg weight equivalent dose of aripiprazole in the form of a long-acting drug-containing suspension which systemically releases aripiprazole, wherein the dose is released over a period of about one month, and wherein the patient is a CYP2D6 and CYP3A4 extensive metabolizer and is concomitantly administered a strong CYP2D6 inhibitor and a strong CYP3A4 inhibitor. 16. The method of claim 15, wherein 53% of a 300 weight equivalent dose of aripiprazole is administered. 17. The method of claim 15, wherein 50% of a 400 mg weight equivalent dose of aripiprazole is administered. 18. The method of claim 15, wherein the long-acting drug-containing suspension comprises a prodrug of aripiprazole. 19. The method of claim 15, wherein the long-acting drug-containing suspension comprises aripiprazole. 20. The method of claim 18, wherein the long-acting drug-containing suspension comprises (7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquin- olin-1(2H)-yl)methyl dodecanoate.