Apixaban - USA

Decision on IPR: Jan. 16, 2019

AIA Review	Filing Date	Institution Date	Petitioner	US Patent	Respondent	Status
IPR2018-00892	04/05/2018	10/15/2018	Mylan Pharmaceuticals Inc.	9,326,945	Pfizer Inc.	Terminated-Settled

US 9,326,945 (Pfizer/BMS; Exp: 02/24/2031) – OB listed

1. A solid pharmaceutical composition comprising a therapeutically effective amount of crystalline apixaban particles and a pharmaceutically acceptable diluent or carrier, wherein the crystalline apixaban particles have a D90 equal to or less than about 89 .mu.m, and wherein at least 77 wt % of apixaban dissolves within 30 minutes in a pH 6.8 phosphate buffer containing 0.05% sodium lauryl sulfate.

12. A solid pharmaceutical composition comprising a therapeutically effective amount of apixaban and a pharmaceutically acceptable diluent or carrier, wherein apixaban comprises crystalline apixaban particles, wherein the crystalline apixaban particles have a D90 equal to or less than about 89 .mu.m, and wherein, as measured using a USP Apparatus 2 at a paddle rotation speed of 75 rpm in 900 mL, of a dissolution medium at 37.degree. C., at least 77 wt % of apixaban in the pharmaceutical composition dissolves within 30 minutes in the dissolution medium, and the dissolution medium is 0.05 M sodium phosphate at a pH 6.8 containing 0.05% sodium lauryl sulfate.