Claims for Patent: 10,143,693

Summary for Patent: 10,143,693

Title:	Dosing regimen for missed doses for long-acting injectable paliperidone esters
Abstract:	The present application provides a method for treating patients in need of psychiatric treatment, wherein said patient is being treated with the 3-month formulation of paliperidone palmitate and fails to take the next scheduled dose of the 3-month formulation of paliperidone palmitate.
Inventor(s):	Gopal; Srihari (Belle Mead, NJ), Ravenstijn; Paulien Gerarda Maria (Waalre, NL), Russu; Alberto (Lange Nieuwstraat, BE), Samtani; Mahesh Narain (Flemington, NJ)
Assignee:	Janssen Pharmaceuticals, Inc. (Beerse, BE)
Application Number:	15/090,889
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,143,693
Patent Claims:	1. A dosing regimen for administering an injectable paliperidone palmitate depot to a patient in need of treatment for psychosis, schizophrenia or bipolar disorder that has been treated with a 3-month injectable paliperidone palmitate depot (PP3M), wherein said patient had been last administered a PP3M injection more than 9 months ago, and the next scheduled maintenance dose of the PP3M should be administered to said patient, comprising: (1) administering intramuscularly in the deltoid muscle of said patient a first reinitiation loading dose of 150 mg eq. of monthly injectable paliperidone palmitate depot (PP1M); (2) administering intramuscularly in the deltoid muscle of said patient a second reinitiation loading dose of 100 mg eq. of PP1M on about the 4th day to about the 12th day after administering said first reinitiation loading dose; (3) administering intramuscularly in the deltoid or gluteal muscle of said patient a first reinitiation maintenance dose of 50 mg eq. to about 150 mg eq. of PP1M on about the 23th day to about the 37th day after administering said second reinitiation loading dose; (4) administering intramuscularly in the deltoid or gluteal muscle of said patient a second reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of PP1M on about the 23rd day to about the 37th day after administering of the first reinitiation maintenance dose; (5) administering intramuscularly in the deltoid or gluteal muscle of said patient a third reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of PP1M on about the 23rd day to about the 37th day after administering of the second reinitiation maintenance dose; and (6) administering intramuscularly in the deltoid or gluteal muscle of said patient from about 175 mg eq. to about 525 mg eq. of PP3M on about the 23rd day to about the 37th day after administering of the last reinitiation maintenance dose of monthly injectable paliperidone palmitate. 2. The method of claim 1, wherein said patient is in need of treatment for psychosis. 3. The method of claim 1, wherein said patient is in need of treatment for schizophrenia. 4. The method of claim 1, wherein said patient is in need of treatment for bipolar disorder. 5. A dosing regimen for administering an injectable paliperidone palmitate depot to a patient in need of treatment for psychosis, schizophrenia or bipolar disorder that has been treated with PP3M, wherein said patient had been last administered a PP3M injection 4 to 9 months ago and the next scheduled maintenance dose of PP3M should be administered to said patient, comprising: (1) administering intramuscularly in the deltoid muscle of said patient a first reinitiation loading dose of PP1M; (2) administering intramuscularly in the deltoid muscle of said patient a second reinitiation loading dose of PP1M on about the 4th day to about the 12th day after administering of said first reinitiation loading dose; and (3) administering intramuscularly in the deltoid or gluteal muscle of said patient a reinitiation dose of PP3M on about the 23rd day to about the 37th day after administering the second reinitiation loading dose of PP1M wherein said first and second reinitiation loading doses and the reinitiation PP3M dose are selected from the table below based on the amount of the missed dose TABLE-US-00011 Missed Dose of Reinitiation Doses Reinitiation Doses PP3M of PP1M of PP3M 175 mg eq. 50 mg eq. 175 mg eq. 263 mg eq. 75 mg eq. 263 mg eq. 350 mg eq. 100 mg eq. 350 mg eq. 525 mg eq. 100 mg eq. 525 mg eq. 6. The method of claim 5, wherein said patient is in need of treatment for psychosis. 7. The method of claim 5, wherein said patient is in need of treatment for schizophrenia. 8. The method of claim 5, wherein said patient is in need of treatment for bipolar disorder. 9. The method of claim 5 wherein the second reinitiation dose of PP1M is administered about 7 days after administering said first reinitiation loading dose of PP1M. 10. The method of claim 9 wherein the second reinitiation dose of PP1M is administered 7 days after administering said first reinitiation loading dose of PP1M. 11. The method of claim 5 wherein the reinitiation dose of PP3M is administered about 30 days after administering said second reinitiation loading dose of PP1M. 12. The method of claim 11 wherein the reinitiation dose of PP3M is administered 30 days after administering said second reinitiation loading dose of PP1M. 13. The method of claim 5 wherein the reinitiation dose of PP3M is administered about a month after administering said second reinitiation loading dose of PP1M. 14. The method of claim 11 wherein the reinitiation dose of PP3M is administered a month after administering said second reinitiation loading dose of PP1M. 15. The method of claim 1 wherein the second reinitiation loading dose of PP1M is administered about 7 days after administering said first reinitiation loading dose of PP1M. 16. The method of claim 15 wherein the second reinitiation loading dose of PP1M is administered 7 days after administering said first reinitiation loading dose of PP1M. 17. The method of claim 1 wherein the first reinitiation maintenance dose of PP1M is administered about 30 days after administering said second reinitiation loading dose of PP1M. 18. The method of claim 1 wherein the first reinitiation maintenance dose of PP1M is administered 30 days after administering said second reinitiation loading dose of PP1M. 19. The method of claim 1 wherein the second reinitiation maintenance of PP1M is administered about 30 days after administering said first reinitiation maintenance dose of PP1M. 20. The method of claim 1 wherein the second reinitiation maintenance of PP1M is administered 30 days after administering said first reinitiation maintenance dose of PP1M. 21. The method of claim 1 wherein the third reinitiation maintenance of PP1M is administered about 30 days after administering said second reinitiation maintenance dose of PP1M. 22. The method of claim 1 wherein the third reinitiation maintenance of PP1M is administered 30 days after administering said second reinitiation maintenance dose of PP1M. 23. The method of claim 1 wherein PP3M is administered about 30 days after administering said last reinitiation maintenance of PP1M. 24. The method of claim 1 wherein PP3M is administered 30 days after administering said last reinitiation maintenance of PP1M. 25. The method of claim 1 wherein PP3M is administered about a month after administering said last reinitiation maintenance of PP1M. 26. The method of claim 1 wherein PP3M is administered a month after administering said last reinitiation maintenance of PP1M. 27. The method of claim 1 further comprising administering intramuscularly in the deltoid or gluteal muscle of said patient a fourth reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of PP1M on about the 23rd day to about the 37th day after administering the third reinitiation maintenance dose. 28. The method of claim 27 wherein said fourth reinitiation maintenance of PP1M is administered about 30 days after administering said third reinitiation maintenance dose of PP1M. 29. The method of claim 28 wherein said fourth reinitiation maintenance of PP1M is administered 30 days after administering said third reinitiation maintenance dose of PP1M.