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Compositions of GLP-1 peptides and preparation thereof - Patent Grant US12594326B2

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Published April 7th, 2026
Detected April 7th, 2026
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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)

← USPTO Patent Grants

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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Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
USPTO
Published
April 7th, 2026
Instrument
Notice
Legal weight
Binding
Stage
Final
Change scope
Minor
Document ID
US12594326B2

Who this affects

Applies to
Pharmaceutical companies Drug manufacturers Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Patent granting IP portfolio management Pharmaceutical formulation
Geographic scope
United States US

Taxonomy

Primary area
Intellectual Property
Operational domain
Legal
Topics
Pharmaceuticals Healthcare

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