Human Serum Albumin in Formulations
Summary
USPTO granted patent US12594337B2 to Regeneron Pharmaceuticals, Inc. covering human serum albumin formulations for reducing fatty acid particle formation in drug products, particularly antibody drug formulations. The patent contains 14 claims and was filed December 30, 2021.
What changed
USPTO issued patent US12594337B2 to Regeneron Pharmaceuticals for drug formulations incorporating human serum albumin at effective concentrations to reduce fatty acid particle formation and solubilize existing particles. The patent specifically covers antibody drug formulations with albumin additives and methods for preparing such formulations.
Regeneron gains exclusive rights to this formulation technology through April 2036 (assuming standard 20-year term from filing), providing potential market protection for albumin-stabilized biologics. Competitors developing similar albumin-containing drug formulations should conduct freedom-to-operate analyses and consider design-arounds or licensing discussions to avoid infringement exposure.
What to do next
- Review patent scope for freedom-to-operate analysis
- Consider licensing opportunities for similar formulation technologies
- Monitor for potential infringement by competitors in the biologics space
Archived snapshot
Apr 7, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Human serum albumin in formulations
Grant US12594337B2 Kind: B2 Apr 07, 2026
Assignee
Regeneron Pharmaceuticals, Inc.
Inventors
Dorothy Kim, Michael Marlow
Abstract
Drug formulations and methods for removing, reducing, or preventing the formation of fatty acid particles in drug formulations are provided. In particular, this disclosure sets forth the inclusion of human serum albumin in an active pharmaceutical agent formulation, such as an antibody drug formulation, at an effective concentration for reducing fatty acid particle formation and solubilizing fatty acid particles.
CPC Classifications
A61K 47/42 A61K 47/26
Filing Date
2021-12-30
Application No.
17566234
Claims
14
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Source
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