Claims for Patent: 10,172,922

Summary for Patent: 10,172,922

Title:	Rapid-acting insulin compositions
Abstract:	The invention is a composition of human insulin or insulin analog that includes treprostinil and that has faster pharmacokinetic action than commercial formulations of existing insulin analog products.
Inventor(s):	Christe; Michael Edward (Pendleton, IN), Hardy; Thomas Andrew (Carmel, IN)
Assignee:	Eli Lilly and Company (Indianapolis, IN)
Application Number:	15/259,101
Patent Claims:	1. A pharmaceutical composition comprising an insulin, treprostinil, one or more preservatives, a tonicity agent, one or more stabilizing agents, and optionally, a buffering agent, wherein treprostinil is present in a concentration sufficient for the composition to have a more rapid onset of insulin action than the same composition which does not contain treprostinil. 2. The pharmaceutical composition of claim 1, wherein the insulin is selected from the group consisting of human insulin, insulin lispro, insulin aspart and insulin glulisine. 3. The pharmaceutical composition of claim 2, wherein the insulin is insulin lispro. 4. The pharmaceutical composition of claim 3, wherein the insulin lispro concentration is either about 100 IU/mL or about 200 IU/mL. 5. The pharmaceutical composition of claim 1, wherein the treprostinil concentration is from about 0.01 to about 30 .mu.M. 6. The pharmaceutical composition of claim 1, wherein the treprostinil concentration is from about 1.5 to about 5.9 .mu.M. 7. The pharmaceutical composition of claim 1, wherein the one or more preservatives comprise meta-cresol. 8. The pharmaceutical composition of claim 7, wherein the meta-cresol concentration is from about 2.5 mg/mL to about 3.8 mg/mL. 9. The pharmaceutical composition of claim 7, wherein the meta-cresol concentration is about 3.15 mg/mL. 10. The pharmaceutical composition of claim 1, wherein the tonicity agent is glycerol. 11. The pharmaceutical composition of claim 10, wherein the glycerol concentration is from about 5 to about 20 mg/mL. 12. The pharmaceutical composition of claim 1, wherein the one or more stabilizing agents are selected from the group consisting of zinc, sodium chloride, calcium chloride and arginine. 13. The pharmaceutical composition of claim 1, wherein the one or more stabilizing agents comprise zinc. 14. The pharmaceutical composition of claim 13, wherein the concentration of zinc is from about 0.00525 mg/mL to about 0.131 mg/mL. 15. The pharmaceutical composition of claim 1, comprising a buffering agent. 16. A pharmaceutical composition comprising: a. insulin lispro, in a concentration of about 100 or about 200 IU/mL, b. treprostinil, in a concentration from about 1.5 to about 5.9 .mu.M, c. meta-cresol, in a concentration of about 2.5-3.8 mg/mL, d. glycerol, in a concentration from about 5 to about 20 mg/mL, e. zinc, in a concentration from about 0.00525 to about 0.131 mg/mL, and wherein the pH of the composition is from about 7.0 to about 7.8. 17. The pharmaceutical composition of claim 16, wherein the insulin lispro concentration is about 100 IU/mL. 18. The pharmaceutical composition of claim 16, wherein the insulin lispro concentration is about 200 IU/mL. 19. The pharmaceutical composition of claim 16, wherein the pH of the composition is about 7.4. 20. A method of treating diabetes comprising administering to a human in need thereof an effective dose of the pharmaceutical composition of claim 1.

Details for Patent 10,172,922

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	June 14, 1996		2034-05-08
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	August 06, 1998		2034-05-08
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	September 06, 2007		2034-05-08
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	June 06, 2017		2034-05-08
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	November 15, 2019		2034-05-08