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Last Updated: September 30, 2020

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Patent: 9,968,676

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Summary for Patent: 9,968,676
Title:Subcutaneous anti-HER2 antibody formulations and uses thereof
Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN.TM.), Pertuzumab or T-DM1, 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-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The 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), Grauschopf; Ulla (Riehen, CH), Mahler; Hanns-Christian (Basel, CH), Stauch; Oliver Boris (Freiburg, DE)
Assignee: Genentech, Inc. (South San Francisco, CA)
Application Number:15/053,217
Patent Claims:see list of patent claims

Details for Patent 9,968,676

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Bausch And Lomb VITRASE hyaluronidase INJECTABLE;INJECTION 021640 001 2004-12-21   Start Trial Genentech, Inc. (South San Francisco, CA) 2029-07-31 RX search
Bausch And Lomb VITRASE hyaluronidase INJECTABLE;INJECTION 021640 002 2004-12-21   Start Trial Genentech, Inc. (South San Francisco, CA) 2029-07-31 RX search
Amphastar Pharm AMPHADASE hyaluronidase INJECTABLE;INJECTION 021665 001 2005-11-03   Start Trial Genentech, Inc. (South San Francisco, CA) 2029-07-31 RX search
Akorn Inc HYDASE hyaluronidase INJECTABLE;INJECTION 021716 001 2005-10-25   Start Trial Genentech, Inc. (South San Francisco, CA) 2029-07-31 DISCN search
Genentech HERCEPTIN trastuzumab VIAL; INTRAVENOUS 103792 001 1998-09-25   Start Trial Genentech, Inc. (South San Francisco, CA) 2029-07-31 RX Orphan search
Genentech PERJETA pertuzumab VIAL; SINGLE-USE 125409 001 2012-06-08   Start Trial Genentech, Inc. (South San Francisco, CA) 2029-07-31 RX search
Genentech Inc HERCEPTIN HYLECTA trastuzumab; hyaluronidase-oysk INJECTABLE;SUBCUTANEOUS 761106 001 2019-02-28   Start Trial Genentech, Inc. (South San Francisco, CA) 2029-07-31 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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