Patent: 9,352,027

Summary for Patent: 9,352,027

Title:	Albumin-free factor VIII formulations
Abstract:	A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.
Inventor(s):	Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
Assignee:	Baxalta GmbH , University of Connecticut , Baxalta Inc
Application Number:	US14/286,391
Patent Claims:	see list of patent claims

Details for Patent 9,352,027

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779	27-Jun-01		2034-05-23
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779	6-Jul-01		2034-05-23

International Patent Family for US Patent 9,352,027

Country	Patent Number	Estimated Expiration
Austria	E365052
Australia	2884300
Australia	777972