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Last Updated: November 28, 2021

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Patent: 10,280,227

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Summary for Patent: 10,280,227
Title:Highly concentrated pharmaceutical formulations
Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. .alpha.,.alpha.-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.
Inventor(s): Adler; Michael (Riehen, CH), Mahler; Hanns-Christian (Basel, CH), Stauch; Oliver Boris (Freiburg, DE)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:14/260,558
Patent Claims:see list of patent claims

Details for Patent 10,280,227

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 2004-05-05 ⤷  Free Forever Trial 2029-09-11
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 2004-12-02 ⤷  Free Forever Trial 2029-09-11
Amphastar Pharmaceuticals, Inc. AMPHADASE hyaluronidase Injection 021665 2004-10-26 ⤷  Free Forever Trial 2029-09-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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