US 11123331

A concise summary of US Patent 11,123,331 is as follows:

Title: Tacrolimus for improved treatment of transplant patients

Assignee: Veloxis Pharmaceuticals, Inc.

Inventors: Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling

Filing Date: October 30, 2020

Issue Date: September 21, 2021

Abstract:
The patent describes an extended-release oral dosage form of tacrolimus, or a similar active compound, designed for once-daily use in immunosuppressive therapy for patients, particularly those who have received kidney or liver transplants. This formulation is designed to release the drug over a prolonged period, which leads to high bioavailability and a better pharmacokinetic profile compared to older, conventional formulations.

Plain-Language Overview of Independent Claims:

At the time of this analysis, I have been unable to authoritatively locate and review the full text of the independent claims for US Patent 11,123,331. A detailed, plain-language explanation of each independent claim requires direct analysis of the "Claims" section of the patent document, which was not available in the information retrieved.

However, based on the abstract and detailed description, the independent claims likely focus on:

• A method of treating a transplant patient by administering a once-daily, extended-release oral dosage form of tacrolimus. A key aspect of this claim would be the specific release profile of the drug, likely defined by the percentage of tacrolimus released over certain time intervals when tested under specific laboratory conditions. This release profile is slower and more prolonged than that of immediate-release versions of the drug.
• An extended-release oral dosage form of tacrolimus with specific pharmacokinetic properties when administered to a patient. This would likely be defined by parameters such as the maximum concentration of the drug in the blood (Cmax), the time it takes to reach that maximum concentration (Tmax), and the total drug exposure over time (AUC). The claims would likely specify that their formulation results in a lower peak concentration and a more consistent drug level in the blood over a 24-hour period compared to existing treatments.

Litigation:

A search of the CAFC (Court of Appeals for the Federal Circuit) dockets for 2026 did not reveal any litigation specifically involving US Patent 11,123,331. However, this does not definitively mean no litigation exists, as it may not yet have reached the appellate level or may be filed under different cause numbers.