Claims for Patent: 11,759,446

Summary for Patent: 11,759,446

Title:	Liquid tasimelteon formulations and methods of use thereof
Abstract:	Liquid suspensions of tasimelteon and methods for their use.
Inventor(s):	Deepak Phadke, Mihael Polymeropoulos
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US17/216,427
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,759,446
Patent Claims:	1. A method of treating Smith-Magenis Syndrome (SMS) in a patient in need thereof, the method comprising: determining a body mass of the patient; and in the case that the body mass of the patient is equal to or less than 28 kg, administering to the patient, once daily, a first dose of tasimelteon equal to 0.7 mg/kg in a liquid formulation, wherein the method includes shaking the liquid formulation for at least 15 seconds before administering to the patient; or in the case that the body mass of the patient is greater than 28 kg, administering to the patient, once daily, a second dose of tasimelteon equal to 20 mg. 2. The method of claim 1, wherein the liquid formulation comprises: a homogeneous aqueous suspension of tasimelteon; a suspending agent; a taste-masking agent; an opacity-imparting agent; and a surfactant, wherein the composition has a viscosity less than or equal to 150 cps and a specific gravity of greater than 1-1.5 under ambient conditions. 3. The method of claim 2, wherein the suspending agent includes at least one cellulosic suspending agent selected from a group consisting of: methylcellulose, hydroxypropyl methylcellulose (HPMC), sodium carboxypropylmethylcellulose (CPMC), carboxymethylcellulose sodium, and microcrystalline cellulose. 4. The method of claim 3, wherein the at least one cellulosic suspending agent includes microcrystalline cellulose and carboxymethylcellulose sodium. 5. The method of claim 2, wherein tasimelteon is present in the liquid formulation at a concentration of: 1 to 6 mg/mL; or 2 to 5 mg/mL; or 1 mg/mL; or 4 mg/mL; and the suspending agent is microcrystalline cellulose and sodium carboxymethylcellulose and is present in a concentration of: 10 to 30 mg/mL; or 10 to 20 mg/mL; or 20 mg/mL. 6. The method of claim 2, wherein the liquid formulation comprises: mannitol as the opacity-imparting agent at a concentration of: no more than 200 mg/mL; or less than 200 mg/mL; or 50 to 100 mg/mL; or 100 mg/mL; sucrose as the taste-masking agent at a concentration of: no more than 300 mg/mL; or less than 300 mg/mL; or 150 to 250 mg/mL; or 200 mg/mL; and polysorbate 80 as the surfactant at a concentration of: 1 to 5 mg/mL; or 1 to 3 mg/mL; or 2 mg/mL. 7. A method of treating Smith-Magenis Syndrome (SMS) in a patient in need thereof, the method comprising: determining a body mass of the patient; and in the case that the body mass of the patient is equal to or less than 28 kg, administering to the patient, once daily, a first dose of tasimelteon equal to 0.7 mg/kg in a liquid formulation, wherein the method includes shaking the liquid formulation for at least 30 seconds before administering to the patient; or in the case that the body mass of the patient is greater than 28 kg, administering to the patient, once daily, a second dose of tasimelteon equal to 20 mg. 8. The method of claim 7, wherein the liquid formulation comprises: a homogeneous aqueous suspension of tasimelteon; a suspending agent; a taste-masking agent; an opacity-imparting agent; and a surfactant, wherein the composition has a viscosity less than or equal to 150 cps and a specific gravity of greater than 1-1.5 under ambient conditions. 9. The method of claim 8, wherein the suspending agent includes at least one cellulosic suspending agent selected from a group consisting of: methylcellulose, hydroxypropyl methylcellulose (HPMC), sodium carboxypropylmethylcellulose (CPMC), carboxymethylcellulose sodium, and microcrystalline cellulose. 10. The method of claim 9, wherein the at least one cellulosic suspending agent includes microcrystalline cellulose and carboxymethylcellulose sodium. 11. The method of claim 8, wherein tasimelteon is present in the liquid formulation at a concentration of: 1 to 6 mg/mL; or 2 to 5 mg/mL; or 1 mg/mL; or 4 mg/mL; and the suspending agent is microcrystalline cellulose and sodium carboxymethylcellulose and is present in a concentration of: 10 to 30 mg/mL; or 10 to 20 mg/mL; or 20 mg/mL. 12. The method of claim 8, wherein the liquid formulation comprises: mannitol as the opacity-imparting agent at a concentration of: no more than 200 mg/mL; or less than 200 mg/mL; or 50 to 100 mg/mL; or 100 mg/mL; sucrose as the taste-masking agent at a concentration of: no more than 300 mg/mL; or less than 300 mg/mL; or 150 to 250 mg/mL; or 200 mg/mL; and polysorbate 80 as the surfactant at a concentration of: 1 to 5 mg/mL; or 1 to 3 mg/mL; or 2 mg/mL. 13. The method of claim 12, wherein the liquid formulation further comprises: a high-intensity sweetener; an antioxidant; sodium chloride; and a flavoring agent. 14. The method of claim 6, wherein the liquid formulation further comprises: a high-intensity sweetener; an antioxidant; sodium chloride; and a flavoring agent.