Claims for Patent: 10,213,508

Summary for Patent: 10,213,508

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:	15/716,005
Patent Claims:	1. A stabilized aqueous pharmaceutical composition comprising a) etanercept, b) buffer, and c) stabilizer comprising 6 to 10 weight % xylitol, wherein the composition has a pH of 6.0 to 6.6, or a pH within 10 percent of 6.0 and 6.6 and is free or essentially free of arginine. 2. The composition of claim 1, wherein the pH is 6.3 or a pH within 10 percent of 6.3. 3. The composition of claim 1, comprising 25 to 75 mg/mL of etanercept. 4. The composition of claim 3, further comprising up to 100 mM NaCl and up to 5 wt. % sucrose. 5. The composition of claim 1, comprising xylitol in an amount of 10 wt. % of the composition. 6. The composition of claim 1, comprising 25 to 75 mg/mL of etanercept. 7. The composition of claim 6, comprising 50 mg/mL or a concentration within 10 percent of 50 mg/ml of etanercept. 8. The composition of claim 7, comprising 10 wt. % xylitol. 9. The composition of claim 7, comprising 6 wt. % xylitol. 10. The composition of claim 6, further comprising up to 100 mM NaCl and up to 5 wt. % sucrose. 11. The composition of claim 1, further comprising one or more additional components selected from a tonicity modifier and an excipient. 12. The composition of claim 1, further comprising up to 100 mM NaCl. 13. The composition of claim 1, further comprising up to 5 wt. % sucrose. 14. A stabilized aqueous pharmaceutical composition comprising a) 25 to 75 mg/mL of etanercept, b) buffer, and c) stabilizer comprising xylitol in an amount of 6 to 10 wt. % of the composition, wherein the composition has a pH of 6.3 or a pH within 10 percent of 6.3, and is free or essentially free of arginine. 15. The composition of claim 14, comprising 50 mg/mL or a concentration within 10 percent of 50 mg/ml of etanercept. 16. The composition of claim 15, further comprising up to 100 mM NaCl and up to 5 wt. % sucrose. 17. The composition of claim 14, comprising 6 wt. % xylitol. 18. The composition of claim 14, comprising 50 mg/mL or a concentration within 10 percent of 50 mg/ml of etanercept and 10 wt. % xylitol. 19. The composition of claim 14, comprising 50 mg/mL or a concentration within 10 percent of 50 mg/ml of etanercept and 6 wt. % xylitol. 20. The composition of claim 14, further comprising one or more additional components selected from a tonicity modifier and an excipient. 21. The composition of claim 14, further comprising up to 100 mM NaCl. 22. The composition of claim 14, further comprising up to 5 wt. % sucrose. 23. The composition of claim 14, further comprising up to 100 mM NaCl and up to 5 wt. % sucrose. 24. The composition of claim 23, wherein the composition has osmolality of 180 to 420 milliosmoles or an osmolality within 10 percent of 180 to 420 milliosmoles; the composition is suitable for administration to a subject as a single dose; and the dose contains 10-80 mg/dose etanercept.

Details for Patent 10,213,508

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2039-03-17
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2039-03-17
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2039-03-17