Claims for Patent: 12,629,404

Summary for Patent: 12,629,404

Title:	GIP/GLP1 agonist compositions
Abstract:	A composition of tirzepatide, comprising an agent selected from NaCl and propylene glycol; and dibasic sodium phosphate is provided.
Inventor(s):	Vincent John Corvari, Christopher Sears Minie, Dinesh Shyamdeo Mishra, Ken Kangyi Qian
Assignee:	Eli Lilly and Co
Application Number:	US19/379,195
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,629,404
Patent Claims:	1. A pharmaceutical composition comprising: (a) tirzepatide, or a pharmaceutically acceptable salt thereof; and (b) from about 6.2 mg/mL to about 9.5 mg/mL of sodium chloride (NaCl), wherein the pharmaceutical composition has a pH of from about 6.5 to about 7.5 and the composition is free of preservative. 2. The pharmaceutical composition of claim 1, wherein the composition comprises from about 7.0 mg/mL to about 9.0 mg/mL of NaCl. 3. The pharmaceutical composition of claim 2, wherein the composition comprises about 8.2 mg/mL of NaCl. 4. The pharmaceutical composition of claim 1, wherein the composition has a pH of from about 6.7 to about 7.3. 5. The pharmaceutical composition of claim 1, wherein the composition comprises from about 5 mg/mL to about 30 mg/mL of tirzepatide, or a pharmaceutically acceptable salt thereof. 6. The pharmaceutical composition of claim 5, wherein the composition comprises 5 mg/mL, 10 mg/mL, 15 mg/mL, 20 mg/mL, 25 mg/mL, or 30 mg/mL of tirzepatide, or a pharmaceutically acceptable salt thereof. 7. The pharmaceutical composition of claim 1, wherein the composition is administered using a pre-filled syringe, a pre-filled pen, or an automatic injection apparatus. 8. The pharmaceutical composition of claim 1, wherein the composition is in a vial. 9. The pharmaceutical composition of claim 6, wherein the composition comprises about 8.2 mg/mL of NaCl. 10. The pharmaceutical composition of claim 9, wherein the composition comprises dibasic sodium phosphate at a concentration of from about 0.67 mg/mL to about 2.68 mg/mL. 11. The pharmaceutical composition of claim 10, wherein the composition is administered using a pre-filled syringe, a pre-filled pen, or an automatic injection apparatus. 12. The pharmaceutical composition of claim 10, wherein the composition is in a vial. 13. A pharmaceutical composition comprising: (a) tirzepatide, or a pharmaceutically acceptable salt thereof; (b) from about 6.2 mg/mL to about 9.5 mg/mL of NaCl; and (c) dibasic sodium phosphate, wherein the composition is free of preservative. 14. The pharmaceutical composition of claim 13, wherein the composition comprises from about 7.0 mg/mL to about 9.0 mg/mL of NaCl. 15. The pharmaceutical composition of claim 14, wherein the composition comprises about 8.2 mg/mL of NaCl. 16. The pharmaceutical composition of claim 13, wherein the dibasic sodium phosphate concentration is from about 1 mg/mL to about 3 mg/mL. 17. The pharmaceutical composition of claim 13, wherein the dibasic sodium phosphate concentration is from about 0.67 mg/mL to about 2.68 mg/mL. 18. The pharmaceutical composition of claim 17, wherein the dibasic sodium phosphate concentration is about 1.34 mg/mL. 19. The pharmaceutical composition of claim 13, wherein the composition comprises 5 mM of dibasic sodium phosphate. 20. The pharmaceutical composition of claim 13, wherein the composition comprises from about 5 mg/mL to about 30 mg/mL of tirzepatide, or a pharmaceutically acceptable salt thereof. 21. The pharmaceutical composition of claim 17, wherein the composition comprises 5 mg/mL, 10 mg/mL, 15 mg/mL, 20 mg/mL, 25 mg/mL, or 30 mg/mL of tirzepatide, or a pharmaceutically acceptable salt thereof. 22. The pharmaceutical composition of claim 13, wherein the composition is administered using a pre-filled syringe, a pre-filled pen, or an automatic injection apparatus. 23. The pharmaceutical composition of claim 13, wherein the composition is in a vial. 24. The pharmaceutical composition of claim 13, wherein the pharmaceutical composition has a pH of from about 6.5 to about 7.5. 25. The pharmaceutical composition of claim 21, wherein the pharmaceutical composition has a pH of from about 6.5 to about 7.5. 26. The pharmaceutical composition of claim 25, wherein the composition comprises about 8.2 mg/mL of NaCl. 27. The pharmaceutical composition of claim 26, wherein the composition is administered using a pre-filled syringe, a pre-filled pen, or an automatic injection apparatus. 28. The pharmaceutical composition of claim 26, wherein the composition is in a vial. 29. A method for treating type-2 diabetes comprising administering to a human in need thereof an effective dose of the pharmaceutical composition of claim 1. 30. A method for treating obesity comprising administering to a human in need thereof an effective dose of the pharmaceutical composition of claim 1. 31. A method for treating type-2 diabetes comprising administering to a human in need thereof an effective dose of the pharmaceutical composition of claim 13. 32. A method for treating obesity comprising administering to a human in need thereof an effective dose of the pharmaceutical composition of claim 13.