Claims for Patent: 9,340,611

Summary for Patent: 9,340,611

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:	14/643,844
Patent Claims:	1. A buffered aqueous pharmaceutical composition comprising: (i) adalimumab; (ii) a buffer consisting of solely histidine; and (iii) a stabilizer, consisting essentially of an amino acid selected from glycine, arginine, methionine or combinations thereof; wherein the composition does not contain polyol, has a pH of about 5 to about 6, and is stable for one week at 40.degree. C. or two weeks at 25.degree. C. 2. The composition of claim 1 wherein the amino acid is glycine. 3. The composition of claim 1 wherein the composition comprises sodium chloride or sodium sulfate at a concentration of up to 150 mM. 4. The composition of claim 1 having osmolality of 180 to 420 mOsM; wherein the composition is suitable for administration to a subject as a single dosage; the composition has a concentration of adalimumab of 30 to 50 mg/ml; the dosage contains 10 to 80 mg of adalimumab; and wherein the composition optionally comprises phosphate solely as an added stabilizer, and not as a buffer, such that the composition has pH of about 5 to about 6 without phosphate. 5. The composition of claim 4 comprising sodium chloride at a concentration of up to 100 mM and wherein the amino acid consists solely of glycine. 6. The composition of claim 5 wherein the dosage is about 40 mg and has less tendency to cause pain upon administration to a subject in comparison to an adalimumab composition having a buffer that comprises citrate. 7. A buffered aqueous pharmaceutical composition comprising: (i) adalimumab at a concentration of 40 mg/ml; (ii) a buffer consisting solely of histidine; and (iii) a stabilizer, consisting essentially of an amino acid selected from the group consisting of glycine, arginine, methionine and combination thereof; and wherein the composition does not contain polyol, has a pH of about 5 to about 6, and is stable for one week at 40.degree. C. or two weeks at 25.degree. C. 8. The composition of claim 7 wherein the amino acid is glycine. 9. The composition of claim 8, further comprising a salt, selected from sodium chloride and sodium sulfate, present at a concentration of up to 150 mM. 10. The composition of claim 7 having osmolality of 180 to 420 mOsM; wherein the composition is suitable for administration to a subject as a single dosage; the composition has a concentration of adalimumab of 30 to 50 mg/ml; the dosage contains 10 to 80 mg of adalimumab; and wherein the composition optionally may contain phosphate solely as an added stabilizer, and not as a buffer, such that the composition has pH of about 5 to about 6 without phosphate. 11. The composition of claim 10 comprising sodium chloride present at a concentration of up to 100 mM; and wherein the amino acid is glycine. 12. The composition of claim 11 wherein the dosage is about 40 mg and has less tendency to cause pain upon administration to a subject in comparison to an adalimumab composition having a buffer that comprises citrate.

Details for Patent 9,340,611

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2032-09-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2032-09-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2032-09-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2032-09-07
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2032-09-07