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Last Updated: December 24, 2024

Claims for Patent: 10,888,605

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Summary for Patent: 10,888,605

Title:	GLP-1 compositions and uses thereof
Abstract:	The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.01% (w/w) phenol, their preparation, kits comprising such compositions as well as uses thereof.
Inventor(s):	Moeller; Eva Horn (Alleroed, DK), Soerensen; Michael Duelund (Soeborg, DK), Lundqvist; Joakim (Malmoe, SE)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	16/774,666
Patent Claims:	1. A liquid pharmaceutical composition comprising semaglutide and phenol, wherein said composition (a) is for parenteral administration; (b) is an aqueous solution comprising at least 60% w/w) water; or (c) further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent; wherein the semaglutide is in the range of 0.5 mg/ml-5.0 mg/ml; wherein the phenol is no more than 0.1 mg/ml; and wherein the pH of the composition is in between 7.0 and 7.8. 2. The composition according to claim 1, wherein said composition comprises one or more pharmaceutically acceptable excipients. 3. The composition according to claim 2, wherein said one or more pharmaceutically acceptable excipients are selected from the group consisting of a buffer or an isotonic agent. 4. The composition according to claim 3, wherein said buffer is a phosphate buffer. 5. The composition according to claim 3, wherein said isotonic agent is selected from propylene glycol or sodium chloride. 6. The composition according to claim 1, wherein said composition comprises no preservative. 7. The composition according to claim 1, wherein said composition has a pH in the range of 7.0-7.4. 8. The composition according to claim 1, wherein said parenteral administration is subcutaneous administration. 9. The composition according to claim 1, wherein said composition comprises 0.5 mg/ml-5.0 mg/ml semaglutide, propylene glycol and 1.42 mg/ml disodiumhydrogenphosphate dihydrate. 10. The composition according to claim 1, wherein said composition comprises 0.5 mg/ml-5.0 mg/ml semaglutide, sodium chloride and 1.42 mg/ml disodiumhydrogenphosphate dihydrate. 11. A kit comprising a liquid pharmaceutical composition of claim 1 and instructions for use. 12. A kit comprising a liquid pharmaceutical composition of claim 1 and an injection device for administration of said composition to a subject, wherein said injection device is selected from the group consisting of a durable pen and a prefilled pen. 13. A method of treating diabetes comprising administering to a subject in need of such treatment a therapeutically effective amount of a composition according to claim 1. 14. A method of treating obesity comprising administering to a subject in need of such treatment a therapeutically effective amount of a composition according to claim 1.

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