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Last Updated: February 25, 2020

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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 Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Biogen ZINBRYTA daclizumab INJECTABLE;INJECTION 761029 001 2017-05-26   Start Trial Abbvie Biotherapeutics Inc. (Redwood City, CA) 2021-11-08 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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