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Last Updated: April 18, 2024

Claims for Patent: 10,207,000

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Summary for Patent: 10,207,000

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:	15/726,195
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,207,000
Patent Claims:	1. A stable aqueous pharmaceutical composition comprising: i) adalimumab; ii) a single buffer; iii) a surfactant; and iv) a tonicity modifier, wherein the composition is free of mannitol and has a pH of about 5 to about 6. 2. The composition of claim 1, wherein the composition is free of citrate buffer. 3. The composition of claim 1, wherein the tonicity modifier is a sugar. 4. The composition of claim 1, wherein the composition is free of sodium chloride. 5. The composition of claim 1, wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab. 6. The composition of claim 2, wherein the composition is free of sodium chloride. 7. The composition of claim 6, wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab. 8. The composition of claim 2, wherein the tonicity modifier is a sugar. 9. The composition of claim 8, wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab. 10. The composition of claim 8, wherein the composition is free of sodium chloride. 11. The composition of claim 10, wherein the composition has osmolality of about 180 to 420 mOsM; the composition is suitable for administration to a subject as a single dose; and the dose contains about 40 mg of adalimumab.

Details for Patent 10,207,000

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002	⤷ Try a Trial	2039-03-17
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008	⤷ Try a Trial	2039-03-17
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013	⤷ Try a Trial	2039-03-17
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014	⤷ Try a Trial	2039-03-17
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015	⤷ Try a Trial	2039-03-17
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	03/09/2016	⤷ Try a Trial	2039-03-17
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	10/17/2016	⤷ Try a Trial	2039-03-17
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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