Apixaban – USA

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.

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