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Last Updated: August 9, 2020

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Claims for Patent: 9,950,039

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Summary for Patent: 9,950,039
Title:Insulin glargine/lixisenatide fixed ratio formulation
Abstract: The present invention refers to a pharmaceutical composition comprising (a) lixisenatide or/and a pharmaceutically acceptable salt thereof, and (b) insulin glargine or/and a pharmaceutically acceptable salt thereof, wherein the compound (b) and compound (a) are present in a fixed ratio.
Inventor(s): Souhami; Elisabeth (Paris, FR), Silvestre; Louise (Paris, FR)
Assignee: SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE)
Application Number:14/965,586
Patent Claims:1. A method of improving glycemic control in a patient with type 2 diabetes mellitus in need thereof, the method comprising administering to the patient a pharmaceutical composition comprising: (a) lixisenatide or a pharmaceutically acceptable salt thereof at a concentration of 33 .mu.g/mL, and (b) insulin glargine or a pharmaceutically acceptable salt thereof at a concentration of 100 U/mL wherein the patient's type 2 diabetes mellitus is inadequately controlled by treatment with lixisenatide.

2. The method of claim 1, wherein the pharmaceutical composition is administered to the patient parenterally.

3. The method of claim 1, wherein the patient has a glycated hemoglobin (HbA1c) value between about 7% and about 10% when treated with lixisenatide.

4. The method of claim 1, wherein the patient's type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide at the onset of treatment with the pharmaceutical composition.

5. The method of claim 1, wherein the patient's type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide and metformin.

6. The method of claim 1, wherein the patient's type 2 diabetes mellitus is inadequately controlled when treated with lixisenatide, metformin, and a second oral antidiabetic drug (OAD).

7. The method of claim 6, wherein the second OAD is a sulfonylurea, a dipeptidyl-peptidase 4 (DPP-4) inhibitor, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, a glinide, or a combination thereof.

Summary for Patent:   Start Trial

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
14197685Dec 12, 2014
15193940Nov 10, 2015

Details for Patent 9,950,039

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081 001 2000-11-17   Start Trial SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE) 2034-12-12 RX search
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081 002 2000-11-17   Start Trial SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE) 2034-12-12 RX search
Sanofi-aventis U.s. Llc LANTUS insulin glargine INJECTION, SOLUTION 021081 1 2017-06-04   Start Trial SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE) 2034-12-12 search
Eli Lilly And Co BASAGLAR insulin glargine SOLUTION;SUBCUTANEOUS 205692 001 2016-06-17   Start Trial SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE) 2034-12-12 RX search
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471 001 2016-07-27   Start Trial SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE) 2034-12-12 RX search
Sanofi-aventis Us ADLYXIN lixisenatide SOLUTION;SUBCUTANEOUS 208471 002 2016-07-27   Start Trial SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE) 2034-12-12 RX search
Mylan Pharms Inc SEMGLEE insulin glargine INJECTABLE;INJECTION 210605 001 2020-06-11   Start Trial SANOFI-AVENTIS DEUTSCHLAND GMBH (Frankfurt am Main, DE) 2034-12-12 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

International Patent Family for US Patent 9,950,039

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