Claims for Patent: 10,117,909

Summary for Patent: 10,117,909

Title:	Combination of an insulin and a GLP-1 agonist
Abstract:	The invention relates to a drug comprising at least one insulin and at least one GLP-1 receptor agonist.
Inventor(s):	Werner; Ulrich (Frankfurt am Main, DE), Rotthauser; Barbel (Frankfurt am Main, DE)
Assignee:	SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:	15/340,969
Patent Claims:	1. A prefilled syringe comprising a pharmaceutical formulation, wherein the pharmaceutical formulation comprises a combination of: (a) insulin glargine or a pharmaceutically acceptable salt thereof, and (b) desPro.sup.36exendin-4(1-39)-Lys.sub.6-NH.sub.2 (AVE0010) or a pharmaceutically acceptable salt thereof; wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL and a concentration of AVE0010 that is about 33 .mu.g/mL; and wherein the prefilled syringe is configured to administer the pharmaceutical formulation at a dosage of insulin glargine between about 15 units and about 80 units and a dosage of AVE0010 between about 5 .mu.g and about 2 mg. 2. The prefilled syringe of claim 1, wherein the prefilled syringe is configured to administer the pharmaceutical formulation at a dosage of insulin glargine between about 15 units and about 60 units and a dosage of AVE0010 between about 5 .mu.g and about 20 .mu.g. 3. The prefilled syringe of claim 1, wherein the prefilled syringe is configured to administer the pharmaceutical formulation at a dosage of insulin glargine between about 15 units and about 80 units and a dosage of AVE0010 between about 5 .mu.g and about 20 .mu.g. 4. A prefilled syringe comprising a pharmaceutical formulation, wherein the pharmaceutical formulation comprises a combination of: (a) insulin glargine or a pharmaceutically acceptable salt thereof, and (b) desPro.sup.36exendin-4(1-39)-Lys.sub.6-NH.sub.2 (AVE0010) or a pharmaceutically acceptable salt thereof; wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL and a concentration of AVE0010 that is about 20 m/ml to about 150 .mu.g/ml. 5. The prefilled syringe of claim 4, wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL and a concentration of AVE0010 that is about 25, 33, 40, 66, or 75m/mL. 6. The prefilled syringe of claim 4, wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL and a concentration of AVE0010 that is about 33 .mu.g/mL. 7. A prefilled syringe comprising a pharmaceutical formulation, wherein the pharmaceutical formulation comprises a combination of: (a) insulin glargine or a pharmaceutically acceptable salt thereof, and (b) desPro.sup.36exendin-4(1-39)-Lys.sub.6-NH.sub.2 (AVE0010) or a pharmaceutically acceptable salt thereof; wherein the pharmaceutical formulation has a concentration of insulin glargine that is about 100 units/mL, and wherein the ratio of insulin glargine and AVE0010 in the pharmaceutical formulation is about 1.5 units to about 4 units of insulin glargine to 1 .mu.g of AVE0010. 8. The prefilled syringe of claim 7, wherein the ratio of insulin glargine and AVE0010 in the pharmaceutical formulation is about 3 units of insulin glargine to 1 .mu.g of AVE0010.

Details for Patent 10,117,909

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	April 20, 2000	10,117,909	2028-10-17
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	April 25, 2007	10,117,909	2028-10-17
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	December 16, 2015	10,117,909	2028-10-17