US 9549918

An analysis of U.S. Patent 9,549,918 reveals a focus on improving the stability of the immunosuppressant drug tacrolimus in pharmaceutical formulations. As of the current date, there is no indication of active litigation involving this patent before the Court of Appeals for the Federal Circuit (CAFC) in 2026.

Summary of U.S. Patent 9,549,918

• Title: Stabilized tacrolimus composition
• Assignee: Veloxis Pharmaceuticals Inc.
• Inventors: Nikolaj Skak, Per Holm
• Filing Date: February 17, 2011
• Issue Date: January 24, 2017
• Abstract: The patent describes a stable pharmaceutical composition of the drug tacrolimus. The invention involves a solid dispersion of tacrolimus within a "vehicle" (an inactive carrier). A key feature is the inclusion of a stabilizing agent that maintains a pH below 7, which helps to prevent or reduce the formation of degradation products, particularly 8-epitacrolimus, during storage.

Plain-Language Overview of Independent Claims

The independent claims of a patent define the core of the invention. For US 9,549,918, these claims broadly cover a stabilized, solid, sustained-release oral dosage form of tacrolimus.

• Claim 1: This claim protects a solid, sustained-release oral dosage form of tacrolimus. The tacrolimus is in a "solid dispersion" mixed with tartaric acid and a carrier vehicle made of polyethylene glycol and poloxamer.

• Claim 8: This claim covers a tablet containing a solid dispersion of tacrolimus with tartaric acid in a vehicle of polyethylene glycol and poloxamer. The defining characteristic of this tablet is that it contains less than 0.2% by weight of the degradation product 8-epitacrolimus.

• Claim 10: This claim is for a tablet with a dispersion of tacrolimus, tartaric acid, and a vehicle of polyethylene glycol and poloxamer. Its novelty lies in its stability over time; it must contain less than 0.5% by weight of the degradation product 8-epitacrolimus after being stored for 12 weeks at 25°C and 60% relative humidity.

• Claim 11: Similar to claim 10, this claim defines a tablet with tacrolimus, tartaric acid, and a vehicle of polyethylene glycol and poloxamer, but with a longer-term stability requirement. It must have less than 0.5% by weight of 8-epitacrolimus after 10 months of storage under the same conditions.

• Claim 12: This claim is for a tablet with a solid dispersion of tacrolimus, tartaric acid, and a vehicle of polyethylene glycol and poloxamer that demonstrates stability under accelerated conditions. The amount of 8-epitacrolimus must not increase by more than 0.5% after 5 weeks at 40°C and 75% relative humidity, or by more than 0.2% after 5 weeks at 25°C and 60% relative humidity.

• Claim 13: This claim describes a stabilized tablet containing a solid dispersion of tacrolimus, tartaric acid, and a vehicle of polyethylene glycol and poloxamer. It is defined by having low levels (no more than 0.5% by weight of each) of several specified degradation products after 5 weeks of storage at 25°C and 60% relative humidity.

• Claim 14: This claim specifies a tablet containing tacrolimus with a vehicle (polyethylene glycol and poloxamer) and a particular concentration of tartaric acid—between approximately 0.05% and 0.6% by weight of the total mixture of tacrolimus, vehicle, and tartaric acid.

• Claim 15: This claim defines a tablet with tacrolimus and a vehicle of polyethylene glycol and poloxamer where the weight ratio of tacrolimus to the stabilizing tartaric acid is within the range of about 19:0.5 to 20:6.

It should be noted that while a search of CAFC dockets for 2026 did not reveal any specific litigation for this patent, records indicate past litigation in the Delaware District Court.