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Last Updated: October 18, 2019

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Claims for Patent: 10,159,733

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Summary for Patent: 10,159,733
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:15/726,215
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,159,733
Patent Claims:1. A stable aqueous pharmaceutical composition comprising: i) adalimumab; ii) a single buffer; iii) a surfactant; and iv) a sugar, 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 2, wherein the single buffer is acetate.

4. The composition of claim 1, wherein the surfactant is polysorbate 80.

5. The composition of claim 1, wherein the sugar is sucrose.

6. The composition of claim 5, wherein the single buffer is acetate and the surfactant is polysorbate 80.

7. The composition of claim 6, wherein the composition is free of sodium chloride.

8. 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.

9. The composition of claim 8, wherein the single buffer is acetate, the surfactant is polysorbate 80, and the sugar is sucrose.

Details for Patent 10,159,733

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31   Start Trial Coherus Biosciences, Inc. (Redwood City, CA) 2039-02-16 RX search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   Start Trial Coherus Biosciences, Inc. (Redwood City, CA) 2039-02-16 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

International Patent Family for US Patent 10,159,733

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