Claims for Patent: 10,058,589

Summary for Patent: 10,058,589

Title:	Stable pharmaceutical composition of Etanercept in a phosphate citrate buffer with glycine as an anti-aggregating agent
Abstract:	The present invention relates to the stable pharmaceutical compositions comprising tumor necrosis factor receptor Fc fusion protein (TNFR:Fc). More particularly, it relates to the stable pharmaceutical compositions comprising tumor necrosis factor receptor Fc fusion protein (TNFR:Fc), phosphate-citrate buffer. It also relates to the methods of manufacturing the composition, method of administration and kits containing the same.
Inventor(s):	Apte-Deshpande; Anjali Deepak (Maharashtra, IN), Deokar; Vaibhav Dyaneshwar (Maharashtra, IN), Mody; Rustom Sorab (Maharashtra, IN)
Assignee:	LUPIN LIMITED (Mumbai, Maharashtra, IN)
Application Number:	14/438,404
Patent Claims:	1. A stable liquid pharmaceutical composition comprising Etanercept, phosphate-citrate buffer, -glycine, sucrose, and sodium chloride. 2. The pharmaceutical composition of claim 1, comprising 10 mg/ml to 100 mg/ml of Etanercept, about 10 mM to 100 mM of phosphate-citrate buffer, about 10 mM to 300 mM glycine, about 50 mM to 120 mM sodium chloride and about 0.5 wt % to 10 wt % sucrose. 3. The stable pharmaceutical composition of claim 1, wherein the composition has a pH in the range of 5 to 7. 4. The stable pharmaceutical composition of claim 1, wherein the composition is sterile and ready for parenteral administration. 5. The pharmaceutical composition of claim 1 comprising 10 mg/ml to 100 mg/ml of Etanercept, about 10 mM to 100 mM of phosphate-citrate buffer, about 10 mM to 300 mM glycine, about 0 mM to 150 mM sodium chloride and about 0.5 wt % to 10 wt % sucrose. 6. The pharmaceutical composition of claim 2 comprising 50 mg/ml of Etanercept, about 16.6 mM of phosphate buffer, about 15.3 mM of citrate buffer, about 75 mM glycine, about 65 mM sodium chloride and about 1 wt % sucrose. 7. The pharmaceutical composition of claim 2 comprising 50 mg/ml of Etanercept, about 31.9 mM of phosphate-citrate buffer, about 75 mM glycine, about 65 mM sodium chloride and about 1 wt % sucrose.

Details for Patent 10,058,589

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2032-10-26
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2032-10-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2032-10-26
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2032-10-26
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2032-10-26
Immunex Corporation	ENBREL	etanercept	Injection	103795			2032-10-26