Patent: 8,431,380

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Summary for Patent: 8,431,380

Title:	Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof
Abstract:	The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGP\'s), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated forms of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.
Inventor(s):	Bookbinder; Louis (San Diego, CA), Kundu; Anirban (San Diego, CA), Frost; Gregory I. (Del Mar, CA)
Assignee:	Halozyme, Inc. (San Diego, CA)
Application Number:	12/378,984
Patent Claims:	see list of patent claims

Details for Patent 8,431,380

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	⤷ Sign Up	2023-03-05
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	December 02, 2004	⤷ Sign Up	2023-03-05
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	October 26, 2004	⤷ Sign Up	2023-03-05
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	October 25, 2005	⤷ Sign Up	2023-03-05
Halozyme Therapeutics, Inc.	HYLENEX RECOMBINANT	hyaluronidase human	Injection	021859	December 02, 2005	⤷ Sign Up	2023-03-05
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 8,431,380

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Country	Patent Number	Estimated Expiration
Austria	E448323	⤷ Sign Up
Australia	2004218354	⤷ Sign Up
Australia	2006216545	⤷ Sign Up
Australia	2009245838	⤷ Sign Up
Australia	2013202475	⤷ Sign Up
Brazil	PI0408116	⤷ Sign Up
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