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 |