Patent: 8,298,530
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Summary for Patent: 8,298,530
Title: | Stable lyophilized pharmaceutical formulation of IgG antibodies |
Abstract: | This invention is directed to a stable lyophilized pharmaceutical formulation prepared by lyophilizing an aqueous formulation comprising a high concentration, e.g. 50 mg/ml or more, of an IgG antibody in about 5-25 mM histidine buffer having pH from about 5.5 to about 6.5, about 0.005%-0.03% polysorbate, sucrose, and optionally serine, and/or mannitol. This lyophilized formulation is stable at room temperature for at least 6 months, and preferably 1 year. This lyophilized formulation has a short reconstitution time of less than 2 minutes, and is suitable for parenteral administration such as intravenous, intramuscular, intraperitoneal, or subcutaneous injection. This invention is exemplified by the anti-IL2 receptor antibody. |
Inventor(s): | Kaisheva; Elizabet A. (Belmont, CA), Flores-Nate; Aleni (Union City, CA), Gupta; Supriya (Sunnyvale, CA) |
Assignee: | Facet Biotech Corporation (Redwood City, CA) |
Application Number: | 12/540,320 |
Patent Claims: | see list of patent claims |
Details for Patent 8,298,530
Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Approval Date | Patent No. | Expiredate |
---|---|---|---|---|---|---|---|
Hoffmann-la Roche Inc. | ZENAPAX | daclizumab | Injection | 103749 | 12/10/1997 | ⤷ Try a Trial | 2021-07-25 |
Biogen Inc. | ZINBRYTA | daclizumab | Injection | 761029 | 05/27/2016 | ⤷ Try a Trial | 2021-07-25 |
Biogen Inc. | ZINBRYTA | daclizumab | Injection | 761029 | 05/26/2017 | ⤷ Try a Trial | 2021-07-25 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |