Claims for Patent: 9,808,525

Summary for Patent: 9,808,525

Title:	Stable aqueous formulations of adalimumab
Abstract:	The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.
Inventor(s):	Manning; Mark (Johnstown, CO), Payne; Robert W. (Fort Collins, CO)
Assignee:	Coherus Biosciences, Inc. (Redwood City, CA)
Application Number:	14/879,885
Patent Claims:	1. An aqueous formulation of adalimumab comprising: (a) adalimumab; (b) a buffer selected from the group consisting of citrate, phosphate, histidine, succinate, tartrate, maleate and acetate, and combinations thereof, provided the combinations do not include a combination of citrate buffer and phosphate buffer; (c) a polyol; (d) a salt selected from the group consisting essentially of sodium chloride, sodium sulfate, and potassium chloride; and (e) a surfactant, wherein the formulation has pH of 4 to 8. 2. The formulation of claim 1, wherein the buffer comprises a citrate buffer. 3. The formulation of claim 1, wherein the polyol is mannitol, trehalose or sorbitol. 4. The formulation of claim 1, wherein the surfactant is PS80. 5. The formulation of claim 1, wherein the formulation does not comprise phosphate. 6. The formulation of claim 1, wherein the salt is sodium chloride. 7. An aqueous formulation of adalimumab comprising: (a) 20 to 150 mg/ml of adalimumab; (b) a citrate buffer; (c) mannitol in an amount of 1 to 10% weight by volume of the total formulation (w/v); (d) sodium chloride in an amount of 5 to 150 mM; and (e) PS80 in amount of 1 to 50 .mu.M; wherein the formulation has a pH of 4 to 8 and does not contain phosphate. 8. The formulation of claim 7, wherein the amount of citrate buffer is 10 to 20 mM; the amount of mannitol is 65 mM; the amount of sodium chloride is 100 mM; the amount of PS80 is 0.1% and the amount of adalimumab is 30 to 50 mg. 9. The formulation of claim 7, wherein the amount of sodium chloride is less than about 100 mM. 10. The formulation of claim 1, wherein the formulation does not comprise sodium phosphate monobasic monohydrate. 11. The formulation of claim 1, wherein the formulation does not comprise phosphate selected from the group consisting of Fisher phosphate Lot Number: 103372 and Fisher phosphate Lot Number: 113670.

Details for Patent 9,808,525

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2039-02-26
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2039-02-26