Claims for Patent: 11,806,348

Summary for Patent: 11,806,348

Title:	Methods of treatment using pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Abstract:	The present disclosure relates to pharmaceutical capsules comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.
Inventor(s):	Peng Li, Robert Davis
Assignee:	Intra Cellular Therapies Inc
Application Number:	US17/582,516
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,806,348
Patent Claims:	1. A method for the treatment of a disease or disorder involving or mediated by the 5-HT2A receptor, serotonin transporter (SERT), and/or dopamine D1/D2 receptor signaling pathways, comprising administering to a patient in need thereof a pharmaceutical capsule for oral administration, comprising lumateperone: in mono-tosylate salt form, wherein the lumateperone mono-tosylate is in solid crystal form; and wherein the capsule comprises a blend of 10 to 30% by weight of lumateperone mono-tosylate in solid crystal form, 60 to 90% by weight of mannitol, 0.5 to 10% by weight of croscarmellose sodium, 0.1 to 1% by weight of talc, and 0.1 to 3% by weight of magnesium stearate, filled into a gelatin capsule, wherein the capsule comprises the lumateperone mono-tosylate in an amount equivalent to 0.01 to 30 mg or 35 to 45 mg of lumateperone free base. 2. The method of claim 1, wherein the capsule comprises the lumateperone mono-tosylate in an amount equivalent to 10 to 30 mg of lumateperone free base. 3. The method of claim 1, wherein the capsule comprises the lumateperone mono-tosylate in an amount equivalent to 10 to 20 mg of lumateperone free base. 4. The method of claim 1, wherein the capsule comprises the lumateperone mono-tosylate in an amount equivalent to 20 to 30 mg of lumateperone free base. 5. The method of claim 1, wherein the capsule comprises the lumateperone mono-tosylate in an amount equivalent to about 14 mg of lumateperone free base. 6. The method of claim 1, wherein the capsule comprises the lumateperone mono-tosylate in an amount equivalent to about 28 mg of lumateperone free base. 7. The method of claim 1, wherein the capsule comprises the lumateperone mono-tosylate in an amount equivalent to about 42 mg of lumateperone free base. 8. The method of claim 1, wherein the disease or disorder is selected from the group consisting of obesity, anorexia, bulimia, depression, major depressive disorder (MDD), acute depression, post-traumatic depression, anxiety, acute anxiety, panic disorders, phobias, social anxiety disorder, social withdrawal, psychosis, acute psychosis, schizophrenia, positive and/or negative symptoms of schizophrenia, obsessive-compulsive disorder, migraine, attention deficit disorder, attention deficit hyperactivity disorder, sleep disorders, anger disorders, agitation, dementia, Alzheimer's disease, Parkinson's dementia, bipolar disorder, and bipolar depression. 9. The method of claim 1, wherein the disease or disorder is selected from the group consisting of depression, major depressive disorder (MDD), acute depression, post-traumatic depression, anxiety, acute anxiety, panic disorders, social anxiety disorder, psychosis, schizophrenia, positive and/or negative symptoms of schizophrenia, dementia, Alzheimer's disease, Parkinson's disease, bipolar disorder, and bipolar depression. 10. The method of claim 1, wherein the disease or disorder is selected from the group consisting of depression, major depressive disorder (MDD), schizophrenia, negative symptoms of schizophrenia, bipolar disorder, and bipolar depression. 11. The method of claim 1, wherein the disease or disorder is selected from the group consisting of schizophrenia, and negative symptoms of schizophrenia. 12. The method of claim 1, wherein the disease or disorder is selected from the group consisting of bipolar disorder, and bipolar depression. 13. The method of claim 2, wherein the disease or disorder is selected from the group consisting of depression, major depressive disorder (MDD), acute depression, post-traumatic depression, anxiety, acute anxiety, panic disorders, social anxiety disorder, psychosis, schizophrenia, positive and/or negative symptoms of schizophrenia, dementia, Alzheimer's disease, Parkinson's disease, bipolar disorder, and bipolar depression. 14. The method of claim 2, wherein the disease or disorder is selected from the group consisting of depression, major depressive disorder (MDD), schizophrenia, negative symptoms of schizophrenia, bipolar disorder, and bipolar depression. 15. The method of claim 2, wherein the disease or disorder is selected from the group consisting of schizophrenia, and negative symptoms of schizophrenia. 16. The method of claim 2, wherein the disease or disorder is selected from the group consisting of bipolar disorder, and bipolar depression. 17. The method of claim 7, wherein the disease or disorder is selected from the group consisting of depression, major depressive disorder (MDD), acute depression, post-traumatic depression, anxiety, acute anxiety, panic disorders, social anxiety disorder, psychosis, schizophrenia, positive and/or negative symptoms of schizophrenia, dementia, Alzheimer's disease, Parkinson's disease, bipolar disorder, and bipolar depression. 18. The method of claim 7, wherein the disease or disorder is selected from the group consisting of depression, major depressive disorder (MDD), schizophrenia, negative symptoms of schizophrenia, bipolar disorder, and bipolar depression. 19. The method of claim 7, wherein the disease or disorder is selected from the group consisting of schizophrenia, and negative symptoms of schizophrenia. 20. The method of claim 7, wherein the disease or disorder is selected from the group consisting of bipolar disorder, and bipolar depression. 21. The method of claim 1, wherein the disease or disorder is major depressive disorder (MDD). 22. The method of claim 2, wherein the disease or disorder is major depressive disorder (MDD). 23. The method of claim 7, wherein the disease or disorder is major depressive disorder (MDD).