Regeneron PCSK9 Stabilized Antibody Formulation Patent Granted
Summary
The USPTO granted Regeneron Pharmaceuticals patent US12612466B2 covering stabilized pharmaceutical formulations of human anti-PCSK9 antibodies. The formulations include at least one amino acid, sugar, or non-ionic surfactant to achieve substantial antibody stability after storage for several months. The patent contains 7 claims and was filed on April 28, 2023.
“The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human proprotein convertase subtilisin/kexin type 9 (PCSK9).”
About this source
Granted patents in USPTO classification C07K, covering peptides, proteins, antibodies, and related biological molecules. Around 160 grants a month, each with the patent number, title, applicant, inventor names, and full abstract. Unlike published applications (which reveal in-progress research), grants are enforceable rights and signal what a company can now litigate or license. Watch this if you run an antibody or protein biologics program, advise on patent portfolio strategy for biologics companies, scout for licensing opportunities on recently granted claims, or track which research institutions are converting their early peptide work into issued patents.
What changed
The USPTO granted Regeneron Pharmaceuticals a patent covering pharmaceutical formulations of human anti-PCSK9 antibodies stabilized with amino acids, sugars, or non-ionic surfactants. The formulations exhibit substantial antibody stability after several months of storage. This patent adds Regeneron's formulation IP to the landscape for PCSK9-targeted therapies.
For pharmaceutical companies developing or commercializing PCSK9 inhibitors, this patent could create freedom-to-operate considerations for formulations using similar stabilization approaches. Regeneron holds intellectual property protection for their antibody formulation approach, which could be relevant to potential licensing discussions or competitive formulation strategies in the PCSK9 antibody space.
Archived snapshot
Apr 28, 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.
Stabilized formulations containing anti-PCSK9 antibodies
Grant US12612466B2 Kind: B2 Apr 28, 2026
Assignee
REGENERON PHARMACEUTICALS, INC.
Inventors
Scott M. Walsh, Daniel B. Dix
Abstract
The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human proprotein convertase subtilisin/kexin type 9 (PCSK9). The formulations may contain, in addition to an anti-PCSK9 antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.
CPC Classifications
C07K 16/40 A61K 39/3955 A61K 9/19
Filing Date
2023-04-28
Application No.
18308769
Claims
7
Mentioned entities
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