Claims for Patent: 11,992,514

Summary for Patent: 11,992,514

Title:	Ready-to-use bivalirudin compositions
Abstract:	Ready-to-use liquid bivalirudin compositions, methods of using the ready-to-use bivalirudin compositions, and methods of preparing the ready-to-use liquid bivalirudin compositions are provided herein. The liquid ready-to-use bivalirudin compositions comprise a pharmaceutically acceptable amount of bivalirudin.
Inventor(s):	Srikanth Sundaram
Assignee:	Maia Pharmaceuticals Inc
Application Number:	US16/417,362
Patent Claims:	1. A liquid bivalirudin composition comprising: a. bivalirudin (SEQ ID NO: 1), or salts thereof, in an amount of about 5 mg/mL, b. a pharmaceutically acceptable buffering agent comprising about 6 mM sodium acetate, and c. about 10% PEG 400 by weight, wherein the composition has a pH of about 5.25, wherein the percentage of total impurities increases by no more than about 8% from the time of manufacture up to 12 months of storage at 5° C. or up to 1 month of storage at 25° C. as determined by high performance liquid chromatography at a wavelength of 215 nm, wherein the composition is ready-to-use for or ready-to-administer by parenteral injection into a patient in need of an anticoagulant, wherein the composition has not been reconstituted from a lyophilized composition and/or diluted from a liquid concentrate, and wherein the osmolarity of the composition is 200 to 600 mOsm/kg.