Claims for Patent: 9,352,027

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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

Details for Patent 9,352,027

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779	June 27, 2001	9,352,027	2034-05-23
Wyeth Pharmaceuticals Llc	REFACTO	antihemophilic factor (recombinant)	For Injection	103779	July 06, 2001	9,352,027	2034-05-23
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 9,352,027

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	0048635	⤷ Start Trial
United States of America	9669076	⤷ Start Trial
United States of America	8765665	⤷ Start Trial
United States of America	8372800	⤷ Start Trial
United States of America	8058226	⤷ Start Trial
United States of America	7247707	⤷ Start Trial
United States of America	7087723	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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