Compositions of GLP-1 peptides and preparation thereof - Patent Grant US12594326B2
Summary
The USPTO granted US Patent 12594326B2 to Novo Nordisk A/S for pharmaceutical compositions comprising GLP-1 peptides in a dual-granule formulation. The first granule type contains N-(8-(2-hydroxybenzoyl)amino)caprylic acid salt without GLP-1 peptide, while the second contains GLP-1 peptide without the salt. The patent covers the compositions, intermediate granules, and processes for their preparation for medical use.
What changed
Novo Nordisk A/S has been granted US Patent 12594326B2, effective April 7, 2026, covering dual-granule pharmaceutical compositions of GLP-1 peptides and methods of preparation. The patent specifies that granule types are physically separated — one containing the salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid without GLP-1 peptide, and the other containing the GLP-1 peptide without the salt — and covers the combined compositions and preparation processes for medical applications.
For pharmaceutical manufacturers and investors in the GLP-1 therapeutics space, this patent establishes intellectual property protection for a novel formulation approach that may differentiate Novo Nordisk's product portfolio. Generic and biosimilar manufacturers should consider this IP landscape when designing around or licensing GLP-1 composition technologies. Healthcare providers and trial sponsors are not directly affected but should be aware of potential formulation exclusivity implications.
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Source document (simplified)
Compositions of GLP-1 peptides and preparation thereof
Grant US12594326B2 Kind: B2 Apr 07, 2026
Assignee
Novo Nordisk A/S
Inventors
Thomas Kvistgaard Vilhelmsen, Helle Eliasen, Tue Hansen
Abstract
The invention relates to pharmaceutical compositions comprising a first type of granules and a second type of granules, wherein said first type of granules comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and no GLP-1 peptide, and wherein said second type of granules comprises a GLP-1 peptide and no salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, as well as the intermediate granules, processes for the preparation of the granules and compositions, and use thereof in medicine.
CPC Classifications
A61K 38/26 A61K 9/2013 A61K 9/2077 A61K 31/20 A61P 3/00 A61P 3/04 A61P 3/10
Filing Date
2025-03-05
Application No.
19071109
Claims
11
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