Claims for Patent: 10,322,086

Summary for Patent: 10,322,086

Title:	Methods of treating arthritis
Abstract:	The present invention provides methods of treating arthritis. A sustained release composition comprising liposomes and one or more therapeutic agent or a pharmaceutically acceptable salt thereof is administered to a subject in need thereof. The liposomes may be in an aqueous suspension. The sustained release composition can be administered intraarticularly.
Inventor(s):	Hong; Keelung (South San Francisco, CA), Guo; Luke S. S. (South San Francisco, CA), Tseng; Yun-Long (Taipei, TW), Shih; Sheue-Fang (Taipei, TW), Chang; Po-Chun (Taipei, TW), Tsai; Chih-Chiang (Taipei, TW), Lin; Hong-Hui (Taipei, TW)
Assignee:	TLC BIOPHARMACEUTICALS, INC. (South San Francisco, CA) TAIWAN LIPOSOME COMPANY, LTD. (Taipei, TW)
Application Number:	15/695,649
Patent Claims:	1. A method of treating arthritis, comprising: intraarticularly injecting a composition into a joint of a subject in need of treatment for arthritis, said composition comprising: liposomes comprising a mixture of a first phospholipid and a second phospholipid, and cholesterol, the first phospholipid being 1,2-dioleoyl-sn-glycero-3-phosphatidylcholine (DOPC), 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphatidylcholine (POPC), soy phosphatidylcholine (SPC), or egg phosphatidylcholine (EPC), the second phospholipid being polyethyleneglycol distearoylphosphatidylethanolamine (PEG-DSPE) or dipalmitoylphosphatidylglycerol (DOPG), wherein the mole percent of cholesterol is about 10 to about 33 based on the total amount of the phospholipids and cholesterol; and one or more therapeutic agents. 2. The method of claim 1, wherein the composition is prepared by reconstituting a lyophilized lipid cake comprising said mixture of the first phospholipid and the second phospholipid, and said cholesterol with an aqueous solution comprising said one or more therapeutic agents to form an aqueous suspension. 3. The method of claim 1, wherein the composition is prepared by reconstituting a lyophilized combination of said one or more therapeutic agents and a lipid cake comprising said mixture of the first phospholipid and the second phospholipid, and said cholesterol with an aqueous solution to form an aqueous suspension. 4. The method of claim 1, wherein the therapeutic agent is not covalently bound to a phospholipid. 5. The method of claim 1, wherein the first phospholipid is DOPC and the second phospholipid is DOPG. 6. The method of claim 1, wherein the therapeutic agent comprises a water-soluble steroid or a pharmaceutically acceptable salt thereof. 7. The method of claim 6, wherein the water-soluble steroid is dexamethasone sodium phosphate (DSP). 8. The method of claim 6, wherein the water soluble steroid has a potency equivalent from about a 2 mg dose to about 8 mg dose of dexamethasone. 9. The method of claim 1, wherein the therapeutic agent comprises a nonsteroidal anti-inflammatory drug or a pharmaceutically acceptable salt thereof. 10. The method of claim 9, wherein the nonsteroidal anti-inflammatory drug or the pharmaceutically acceptable salt thereof is indomethacin or indomethacin sodium. 11. The method of claim 9, wherein the concentration of the nonsteroidal anti-inflammatory drug or the pharmaceutically acceptable salt thereof is about 4.65 to about 5 mg/ml. 12. The method of claim 1, wherein the therapeutic agent comprises a disease modifying anti-rheumatic drug (DMARD). 13. The method of claim 12, wherein the DMARD comprises a TNF-a antagonist. 14. The method of claim 13, wherein the TNF-a antagonist is etanercept. 15. The method of claim 14, wherein the concentration of etanercept in the composition is about 42.8 mg/ml to about 50 mg/ml. 16. The method of claim 13, wherein the TNF-a antagonist is adalimumab. 17. The method of claim 12, wherein the DMARD comprises methotrexate or a pharmaceutically acceptable salt thereof. 18. The method of claim 17, wherein the pharmaceutically acceptable salt is methotrexate sodium. 19. The method of claim 17, wherein the concentration of methotrexate or the pharmaceutically acceptable salt thereof is about 2.3 to about 2.5 mg/ml. 20. The method of claim 1, wherein the therapeutic agent is encapsulated in an aqueous medium of the liposomes.

Details for Patent 10,322,086

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2032-07-05
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2032-07-05
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2032-07-05
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2032-07-05
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2032-07-05