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Last Updated: March 24, 2023

Patent: 8,465,739

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Summary for Patent: 8,465,739
Title:Stable aqueous pharmaceutical formulations of daclizumab antibodies
Abstract: This invention is directed to a stable liquid pharmaceutical formulation comprising a high concentration, e.g. 50 mg/ml or more, of antibody in about 20-60 mM succinate buffer or 30-70 mM histidine buffer, having pH from about pH 5.5 to about pH 6.5, about 0.01-0.1% polysorbate, and a tonicity modifier that contributes to the isotonicity of the formulation. This liquid formulation is stable at refrigerated temperature (2-8.degree. C.) for at least 1 year, and preferably 2 years. This liquid formulation is suitable for subcutaneous injection. The preferred antibodies include Daclizumab, a humanized anti-IL-2 receptor monoclonal antibody; HAIL-12, a humanized anti-IL-12 monoclonal antibody; HuEP5C7, a humanized anti-L selectin monoclonal antibody; and Flintozumab, a humanized anti-gamma interferon monoclonal antibody.
Inventor(s): Kaisheva; Elizabet A. (Belmont, CA), Gupta; Supriya (Sunnyvale, CA), Duvur; Shanti G. (Fremont, CA), Subramanian; Malathy (Fremont, CA)
Assignee: Abbvie Biotherapeutics Inc. (Redwood City, CA)
Application Number:13/226,372
Patent Claims:see list of patent claims

Details for Patent 8,465,739

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Hoffmann-la Roche Inc. ZENAPAX daclizumab Injection 103749 12/10/1997 See Plans and Pricing 2021-11-08
Biogen Inc. ZINBRYTA daclizumab Injection 761029 05/27/2016 See Plans and Pricing 2021-11-08
Biogen Inc. ZINBRYTA daclizumab Injection 761029 05/26/2017 See Plans and Pricing 2021-11-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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Serving leading biopharmaceutical companies globally:

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