Claims for Patent: 9,820,938

Summary for Patent: 9,820,938

Title:	Stable liquid formulation of AMG 416 (etelcalcetide)
Abstract:	A liquid formulation comprising a peptide agonist of the calcium sensing receptor and method of preparing and using the formulation are provided.
Inventor(s):	Maclean; Derek (Los Altos, CA), Yin; Qun (Palo Alto, CA)
Assignee:	Amgen Inc. (Thousand Oaks, CA)
Application Number:	14/908,481
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,820,938
Patent Claims:	1. A pharmaceutical formulation comprising AMG 416 in aqueous solution, wherein the formulation has a pH of 2.0 to 5.0. 2. The formulation of claim 1, wherein the formulation has a pH of 2.5 to 4.5. 3. The formulation of claim 1, wherein the formulation has a pH of 2.5 to 4.0. 4. The formulation of claim 1, wherein the formulation has a pH of 3.0 to 3.5. 5. The formulation of claim 1, wherein the pH is maintained by a pharmaceutically acceptable buffer. 6. The formulation of claim 5, wherein the buffer is succinate. 7. The formulation of claim 1, wherein the AMG 416 is present in the formulation at a concentration of 0.1 mg/mL to 20 mg/mL. 8. The formulation of claim 1, wherein the AMG 416 is present in the formulation at a concentration of 1 mg/mL to 15 mg/mL. 9. The formulation of claim 1, wherein the AMG 416 is present in the formulation at a concentration of 2.5 mg/mL to 10 mg/mL. 10. The formulation of claim 1, further comprising a pharmaceutically acceptable tonicity modifier. 11. The formulation of claim 10, wherein the tonicity modifier is present in the formulation at a concentration wherein the formulation is approximately isotonic. 12. The formulation of claim 10, wherein the tonicity modifier is sodium chloride. 13. The formulation of claim 1, wherein the formulation has less than 10% degradation when stored at 2-8.degree. C. for 2 years. 14. The formulation of claim 1, wherein the formulation has less than 10% degradation when stored at room temperature for 2 years. 15. A formulation comprising 2 mg/mL to 20 mg/mL of AMG 416 in aqueous solution, a succinate buffer that maintains the formulation at a pH of about 3.0 to 3.5, and a concentration of sodium chloride wherein the formulation is approximately isotonic.