US 8685998

Summary of U.S. Patent No. 8,685,998

A concise summary of U.S. Patent No. 8,685,998 is provided below, based on a review of the United States Patent and Trademark Office (USPTO) database. A search of the 2026 dockets for the Court of Appeals for the Federal Circuit (CAFC) did not yield any results for this patent.

Title: Tacrolimus for improved treatment of transplant patients.

Assignee: The current assignee of record is Veloxis Pharmaceuticals Inc. The original assignee was Veloxis Pharmaceuticals AS.

Inventors:

• Robert D. Gordon
• Per Holm
• Anne-Marie Lademann
• Tomas Norling

Filing Date: July 7, 2009.

Issue Date: April 1, 2014.

Abstract: The patent describes an extended-release oral dosage form of tacrolimus, or a pharmaceutically active analogue, for once-daily immunosuppressive treatment. This formulation is intended for patients who have undergone an organ transplant, particularly a kidney or liver transplant. The dosage form is designed to release the active drug over an extended period, which is claimed to provide high bioavailability and an improved pharmacokinetic profile compared to conventional tacrolimus formulations.

Plain-Language Overview of Independent Claims

U.S. Patent No. 8,685,998 contains three independent claims. A plain-language summary of each is provided below:

Claim 1: This claim protects a method for the initial immunosuppressive treatment of a de novo liver transplant patient (a patient who has just received a new liver). The method involves giving the patient a once-daily oral dosage of tacrolimus in an extended-release formulation. This formulation is characterized by its slow release profile: when tested in a specific lab setting (a USP dissolution test), less than 50% of the tacrolimus is released after 10 hours. The claim asserts that this once-daily, slow-release formulation provides a total drug exposure on the first day of treatment that is at least 50% of the exposure that would be achieved with a conventional, immediate-release tacrolimus product (like Prograf®) given twice a day at the same total daily dose.

Claim 8: This claim is similar to claim 1, but it applies to the initial immunosuppressive treatment of a de novo kidney transplant patient. The core of the claim is the same: a once-daily, extended-release oral tacrolimus dosage form with a slow in-vitro release profile (less than 50% released after 10 hours). The key difference is the claimed therapeutic outcome. For kidney transplant patients, this method is asserted to provide a total drug exposure on the first day that is at least 70% of the exposure from a twice-daily, immediate-release formulation at the same total daily dosage.

Claim 13: This claim also describes a method for the initial treatment of a de novo kidney transplant patient with a once-daily, extended-release oral tacrolimus formulation that releases less than 50% of the drug after 10 hours in a lab test. However, this claim compares the new formulation to a different type of existing product: another extended-release formulation that releases the drug more quickly (specifically, one that releases more than 30% of the tacrolimus within 5 hours). The claim states that the new, slower-releasing formulation provides a total drug exposure on the first day of treatment that is at least 100% of the exposure from the faster extended-release product, when given at the same daily dose.