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Last Updated: March 29, 2024

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 Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 12/31/2002 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 02/21/2008 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 04/24/2013 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 09/23/2014 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 11/23/2015 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 03/09/2016 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 10/17/2016 ⤷  Try a Trial 2039-02-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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