IP Library › Granted Patent US 12,303,598
Granted Patent B2
US 12,303,598 · App. 17/747,723 · Granted May 20, 2025

Pharmaceutical composition comprising a GLP-1-agonist and methionine

Inventors: Anette Brunner-Schwarz (Frankfurt, DE); Werner Mueller (Frankfurt, DE); Verena Siefke-Henzler (Frankfurt, DE)
Assignee: Sanofi-Aventis Deutschland GmbH
A61K9/08A61K9/0019A61K38/2278A61K38/26A61K47/10A61K47/20A61P3/10
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Quick Facts
Patent No.
US 12,303,598
App. No.
17/747,723
Granted
May 20, 2025
Kind
B2
Abstract

A liquid composition comprising a GLP-1 agonist or/and a pharmacologically tolerable salt thereof and, optionally, at least one pharmaceutically acceptable excipient, wherein the composition comprises methionine, as add-on therapy with metformin and/or with long-acting insulin/insulin derivates where appropriate.

Claims (25)

1. An aqueous liquid composition consisting essentially of:

desPro 36 exendin-4(1-39)-Lys 6 -NH2 (“AVE0010”) or a pharmacologically tolerable salt thereof at a concentration of about 0.025 mg/mL to about 0.1 mg/ml;

insulin glargine or a pharmacologically tolerable salt thereof at a concentration of about 3.64 mg/ml;

about 3 mg/mL L-methionine;

about 2.7 mg/ml m-cresol;

about 20 mg/mL 85% glycerol, and

about 30 μg/mL zinc.

2. The aqueous liquid composition of claim 1 , wherein the composition further consists essentially of hydrochloric acid and sodium hydroxide such that the composition has a pH of about 4.5.

3. An aqueous liquid composition consisting essentially of:

about 33 μg desPro 36 exendin-4(1-39)-Lys 6 -NH2 (“AVE0010”) or a pharmacologically tolerable salt thereof;

about 100 units insulin glargine or a pharmacologically tolerable salt thereof;

about 3 mg L-methionine;

about 2.7 mg m-cresol;

about 20 mg 85% glycerol;

about 30 μg zinc, and

water in a quantity sufficient for the volume of the composition to total about 1 mL.

4. The aqueous liquid composition of claim 3 , wherein the composition further consists essentially of hydrochloric acid and sodium hydroxide such that the composition has a pH of about 4.5.

5. An aqueous liquid composition consisting essentially of:

about 50 μg/mL or about 100 μg/mL desPro 36 exendin-4(1-39)-Lys 6 -NH2 (“AVE0010”) or a pharmacologically tolerable salt thereof;

about 9 mg/mL L-methionine;

about 8.1 mg/ml m-cresol;

about 54 mg/mL 85% glycerol;

about 10.5 mg sodium acetate trihydrate, and

water in a quantity sufficient for the volume of the composition to total about 1 mL.

6. The aqueous liquid composition of claim 5 , wherein the composition further consists essentially of hydrochloric acid and sodium hydroxide such that the composition has a pH of about 4.5.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2025
From: BRUNNER-SCHWARZ, ANETTE; MUELLER, WERNER; SIEFKE-HENZLER, VERENA
To: SANOFI-AVENTIS DEUTSCHLAND GMBH
Reel/Frame 070080/0877 →
Priority Claims (2)
DE 102009052832.6 · Nov 13, 2009 · national
DE 102010011919.9 · Mar 18, 2010 · national
Continuity (5)
Continuation 16921422 · Jul 6, 2020
Continuation 16013617 · Jun 20, 2018
Continuation 15595929 · May 15, 2017
Continuation 13509507
Related Publication 20230028647A1 · Jan 26, 2023
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