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Last Updated: April 23, 2024

Claims for Patent: 9,393,305

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Summary for Patent: 9,393,305

Title:	Etanercept formulations stabilized with xylitol
Abstract:	The invention provides stabilized aqueous pharmaceutical etanercept compositions suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.
Inventor(s):	Manning; Mark (Johnstown, CO), Murphy; Brian (Fort Collins, CO)
Assignee:	Coherus Biosciences, Inc. (Redwood City, CA)
Application Number:	13/654,919
Patent Claims:	1. A stabilized aqueous pharmaceutical composition comprising 50 mg/ml etanercept, but no arginine, and a stabilizer to inhibit instability, misfolding, aggregation and/or fragmentation of the etanercept, wherein the stabilizer comprises 10% weight by volume xylitol, 10-30 mM sodium phosphate, and optionally up to 100 mM NaCl, and eliciting long term storage stability as characterized by SEC (size exclusion chromatography) analysis at T.sub.2 of: monomer content greater than 90%. 2. A stabilized aqueous pharmaceutical composition comprising: 50 mg/ml of etanercept, but no arginine, and a stabilizer to inhibit instability, misfolding, aggregation and/or fragmentation of the etanercept, wherein the stabilizer comprises 6 weight by volume xylitol; and 10-30 mM sodium phosphate; and optionally up to 100 mM NaCl, wherein the formulation is characterized by an SEC analysis at T.sub.2 of greater than 90 wt. % monomer content. 3. The composition of claim 1 or 2 having no more than, on average, 10,000 subvisible particles per mL having a size greater than 5 .mu.m.

Details for Patent 9,393,305

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998	⤷ Try a Trial	2039-03-29
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999	⤷ Try a Trial	2039-03-29
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004	⤷ Try a Trial	2039-03-29
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007	⤷ Try a Trial	2039-03-29
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017	⤷ Try a Trial	2039-03-29
Immunex Corporation	ENBREL	etanercept	Injection	103795		⤷ Try a Trial	2039-03-29
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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