Claims for Patent: 9,993,555

Summary for Patent: 9,993,555

Title:	Rapid-acting insulin compositions
Abstract:	The invention is a composition of human insulin or insulin analog that includes specific concentrations of citrate, chloride, in some cases including the addition of sodium chloride, zinc and, optionally, magnesium chloride and/or surfactant, and that has faster pharmacokinetic and/or pharmacodynamic action than commercial formulations of existing insulin analog products.
Inventor(s):	Akers; Michael Patrick (Indianapolis, IN), Nguyen; Chi A. (Fishers, IN), Paavola; Chad D. (Carmel, IN), Sarin; Virender Kumar (Carmel, IN), Schulte; Nanette Elizabeth (Indianapolis, IN), Majumdar; Ranajoy (Indianapolis, IN)
Assignee:	Eli Lilly and Company (Indianapolis, IN)
Application Number:	14/963,279
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,993,555
Patent Claims:	1. A pharmaceutical composition comprising: a. an insulin, in a concentration of about 100 to about 200 IU/mL; b. citrate, in a concentration from about 15 to about 35 mM; c. zinc, in a concentration from about 0.2 to about 0.8 mM; and d. a preservative and wherein the composition does not include EDTA. 2. The pharmaceutical composition of claim 1, wherein the insulin is insulin lispro. 3. The pharmaceutical composition of claim 1, wherein the preservative is selected from the group consisting of phenol and metacresol and mixtures thereof. 4. The pharmaceutical composition of claim 3, wherein the preservative is metacresol. 5. The pharmaceutical composition of claim 4, wherein the metacresol concentration is from about 2.5 to about 3.8 mg/mL. 6. The pharmaceutical composition of claim 1, wherein the composition provides for an uptake of insulin into the blood that is at least 20% more rapid than for compositions which contain the same insulin but which do not contain citrate. 7. The pharmaceutical composition of claim 1, wherein the composition is stable to allow for storage of at least 24 months at 2-8.degree. C. and up to 28 days in-use at temperatures of up to 30.degree. C. 8. The pharmaceutical composition of claim 1, wherein the composition does not include any vasodilatory agent. 9. The pharmaceutical composition of claim 1, wherein the composition does not include any oligosaccharides. 10. A method of treating diabetes comprising administering to a human in need thereof an effective dose of the pharmaceutical composition of claim 1. 11. The pharmaceutical composition of claim 1, further comprising magnesium chloride in a concentration up to about 5 mM. 12. The pharmaceutical composition of claim 11 wherein the concentration of citrate is from about 15 to about 25 mM.

Details for Patent 9,993,555

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	06/14/1996		2040-03-31
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	08/06/1998		2040-03-31
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	09/06/2007		2040-03-31
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	06/06/2017		2040-03-31
Eli Lilly And Company	HUMALOG	insulin lispro	Injection	020563	11/15/2019		2040-03-31
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	12/11/2017		2040-03-31