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Last Updated: March 29, 2024

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 Approval Date Patent No. Expiredate
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 05/05/2004 ⤷  Try a Trial 2029-07-31
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 12/02/2004 ⤷  Try a Trial 2029-07-31
Amphastar Pharmaceuticals, Inc. AMPHADASE hyaluronidase Injection 021665 10/26/2004 ⤷  Try a Trial 2029-07-31
Akorn, Inc. HYDASE hyaluronidase Injection 021716 10/25/2005 ⤷  Try a Trial 2029-07-31
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 09/25/1998 ⤷  Try a Trial 2029-07-31
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 02/10/2017 ⤷  Try a Trial 2029-07-31
Genentech, Inc. PERJETA pertuzumab Injection 125409 06/08/2012 ⤷  Try a Trial 2029-07-31
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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