Claims for Patent: 9,518,111

Summary for Patent: 9,518,111

Title:	Compositions comprising a p75 tumor necrosis factor receptor/Ig fusion protein
Abstract:	The present invention relates to pharmaceutical compositions comprising a p75 tumor necrosis factor receptor/Ig fusion protein.
Inventor(s):	Gombotz; Wayne Richard (Kenmore, WA), Remmele, Jr.; Richard L. (Clarksburg, MD)
Assignee:	Immunex Corporation (Thousand Oaks, CA)
Application Number:	14/478,926
Patent Claims:	1. A pharmaceutical composition comprising a polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1 and from about 10 mM to about 200 mM L-arginine. 2. The pharmaceutical composition of claim 1, wherein the composition is in a liquid state. 3. The pharmaceutical composition of claim 2, wherein the composition is in a pre-filled sterile syringe. 4. The pharmaceutical composition of claim 1, further comprising a buffer. 5. The pharmaceutical composition of claim 4, wherein the buffer is selected from the group consisting of sodium phosphate, histidine, potassium phosphate, sodium citrate, potassium citrate, maleic acid, ammonium acetate, tris-(hydroxymethyl)-aminomethane (tris), acetate and diethanolamine. 6. The pharmaceutical composition of claim 1, further comprising a tonicity modifier. 7. The pharmaceutical composition of claim 6, wherein the tonicity modifier is selected from the group consisting of arginine, cysteine, histidine, glycine, sodium chloride, potassium chloride, sodium citrate, sucrose, glucose and mannitol. 8. The pharmaceutical composition of claim 7, wherein the tonicity modifier is sodium chloride. 9. The pharmaceutical composition of claim 1, further comprising an excipient. 10. The pharmaceutical composition of claim 7, further comprising an excipient. 11. The pharmaceutical composition of claim 9, wherein the excipient is selected from the group consisting of sucrose, lactose, glycerol, xylitol, sorbitol, Mannitol, maltose, inositol, trehalose, glucose, bovine serum albumin (BSA), human SA or recombinant HA, dextran, PVA, hydroxypropyl methylcellulose (HPMC), polyethyleneimine, gelatin, polyvinylpyrrolidone (PVP), hydroxyethylcellulose (HEC), polyethylene glycol, ethylene glycol, glycerol, dimethysulfoxide (DMSO), dimethylformamide (DMF), proline, L-serine, sodium glutamic acid, alanine, glycine, lysine hydrochloride, sarcosine, gamma-aminobutyric acid, polysorbate-20, polysorbate-80, SDS, polysorbate, polyoxyethylene copolymer, potassium phosphate, sodium acetate, ammonium sulfate, magnesium sulfate, sodium sulfate, trimethylamine N-oxide, betaine, zinc ions, copper ions, calcium ions, manganese ions, magnesium ions, CHAPS, sucrose monolaurate, and 2-O-beta-mannoglycerate. 12. The pharmaceutical composition of claim 11, wherein the excipient is sucrose. 13. A pharmaceutical composition comprising about 10 mg/ml to about 100 mg/ml of a polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1, about 10 mM to about 200 mM L-arginine, and sodium phosphate, sodium chloride and sucrose. 14. The pharmaceutical composition of claim 13, wherein the L-arginine is at about 10 mM to about 75 mM. 15. The pharmaceutical composition of claim 13, wherein the sodium phosphate is at about 5 mM to about 100 mM. 16. The pharmaceutical composition of claim 13, wherein the sucrose is at about 0.5% to about 1.5%. 17. The pharmaceutical composition of claim 13, wherein the pH is about 5.5 to about 7.8. 18. The pharmaceutical composition of claim 13, having about 50 mg/ml of the polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1, about 25 mM L-arginine, about 25 mM sodium phosphate, about 98 mM sodium chloride, about 1% sucrose, and wherein the composition is about pH 6.2. 19. The pharmaceutical composition of claim 1, wherein the polypeptide is etanercept. 20. The pharmaceutical composition of claim 4, wherein the polypeptide is etanercept. 21. The pharmaceutical composition of claim 6, wherein the polypeptide is etanercept. 22. The pharmaceutical composition of claim 9, wherein the polypeptide is etanercept. 23. The pharmaceutical composition of claim 13, wherein the polypeptide is etanercept.

Details for Patent 9,518,111

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2022-02-27
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2022-02-27
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2022-02-27
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2022-02-27
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2022-02-27
Immunex Corporation	ENBREL	etanercept	Injection	103795			2022-02-27