US 10166190

US patent 10166190, titled "Stabilized tacrolimus composition," was issued to Veloxis Pharmaceuticals Inc. on January 1, 2019. The application for this patent was filed on January 13, 2017. The inventors are Nikolaj Skak and Per Holm.

Abstract:
The patent describes a stable pharmaceutical composition containing a solid dispersion of tacrolimus in a vehicle. This composition also includes a stabilizing agent designed to maintain a pH below 7 when re-dispersed in water. The primary purpose of this stabilizing agent is to prevent or reduce the formation of major degradation products of tacrolimus, particularly 8-epitacrolimus, during storage.

Plain-Language Overview of Independent Claims:

• Independent Claim 1: This claim covers a pharmaceutical composition that comprises tacrolimus in a solid dispersion within a mixture of a vehicle and a stabilizing agent. The key characteristic is that this stabilizing agent is capable of providing a pH below 7 in the composition when measured after re-dispersion in water.

• Independent Claim 15: This claim describes a method for reducing the concentration of tacrolimus degradation products in a pharmaceutical composition that contains tacrolimus as its active ingredient. The method involves incorporating a stabilizing agent into the composition.

• Independent Claim 16: This claim pertains to a pharmaceutical composition consisting of a dispersion of tacrolimus in a vehicle, where the vehicle specifically includes tartaric acid.

• Independent Claim 19: This claim details a pharmaceutical composition comprising a solid dispersion of tacrolimus in a mixture of a vehicle and a stabilizing agent. The stabilizing agent must be capable of providing a pH below 7 in the composition. A critical feature is that the pharmaceutical composition contains 8-epitacrolimus at a concentration below 0.2% by weight.

• Independent Claim 21: This claim describes a pharmaceutical composition with a dispersion of tacrolimus, characterized by having less than 0.5% of 8-epitacrolimus after 12 weeks of storage at 25°C and 60% relative humidity.

• Independent Claim 22: This claim is similar to Claim 21 but specifies a longer storage period: less than 0.5% of 8-epitacrolimus after 10 months of storage at 25°C and 60% relative humidity.

• Independent Claim 23: This claim describes a pharmaceutical composition with a dispersion of tacrolimus, characterized by having less than 0.5% of 8-epitacrolimus after 3 weeks of storage at 40°C and 75% relative humidity.

• Independent Claim 24: This claim is similar to Claim 23 but specifies a longer storage period: less than 0.5% of 8-epitacrolimus after 19 weeks of storage at 40°C and 75% relative humidity.

• Independent Claim 25: This claim covers a pharmaceutical composition comprising a solid dispersion of tacrolimus in a mixture of a vehicle and a stabilizing agent. The composition meets specific stability criteria regarding 8-epitacrolimus levels: either no more than 0.5% more 8-epitacrolimus after 5 weeks at 40°C/75% RH compared to prior to storage, or no more than 0.2% more 8-epitacrolimus after 5 weeks at 25°C/60% RH compared to prior to storage.

• Independent Claim 26: This claim describes a stabilized pharmaceutical composition comprising a solid dispersion of tacrolimus. It specifies limits for multiple degradation products after 5 weeks of storage at 25°C and 60% relative humidity: no more than 0.5% of 8-epitacrolimus, diene of tacrolimus, C4-epimer diene of tacrolimus, and/or Regioisomer A of tacrolimus.

• Independent Claim 27: Similar to Claim 26, this claim specifies the same limits for the same degradation products, but after 5 weeks of storage at 40°C and 75% relative humidity.

• Independent Claim 28: This claim covers a pharmaceutical composition comprising tacrolimus and between about 0.05% and about 0.6% by weight of tartaric acid.

• Independent Claim 29: This claim describes a pharmaceutical composition comprising tacrolimus and tartaric acid at a specific weight ratio of about 19:0.5 to about 20:6.

CAFC 2026 Dockets:
A targeted search for "CAFC 2026 dockets US10166190" did not yield specific dockets directly linked to this patent number within the provided search results. CAFC dockets are typically searched by case number or party name, and the available results for 2026 scheduling do not list cases by patent number. Therefore, authoritative information on potential litigation for patent US10166190B2 in CAFC 2026 dockets is not available through this search.