Last Updated: June 25, 2026

Patent: 10,752,696

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Summary for Patent: 10,752,696

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:	16/450,906
Patent Claims:	see list of patent claims

Details for Patent 10,752,696

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	May 05, 2004	⤷ Start Trial	2039-06-24
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	December 02, 2004	⤷ Start Trial	2039-06-24
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	October 26, 2004	⤷ Start Trial	2039-06-24
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	October 25, 2005	⤷ Start Trial	2039-06-24
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 10,752,696

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Country	Patent Number	Estimated Expiration
Argentina	078161	⤷ Start Trial
Australia	2010294186	⤷ Start Trial
Brazil	112012005017	⤷ Start Trial
Canada	2771571	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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