Claims for Patent: 9,511,123

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Summary for Patent: 9,511,123

Title:	Combined use of a sulfated glycosaminoglycan and a hyaluronidase for improving the bioavailability of factor VIII
Abstract:	The present invention relates to pharmaceutical preparations comprising Factor VIII, a sulfated glycosaminoglycan and a hyaluronidase for the non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders. The invention further relates to the combined use of a Factor VIII, a sulfated glycosaminoglycan and a hyaluronidase for the treatment and prevention of bleeding disorders, and to a method for increasing the bioavailability after non-intravenous administration of Factor VIII by co-administration of a sulfated glycosaminoglycan and a hyaluronidase.
Inventor(s):	Zollner; Sabine (Muri, CH), Metzner; Hubert (Marburg, DE)
Assignee:	CSL Behring GmbH (Marburg, DE)
Application Number:	14/351,502
Patent Claims:	1. A pharmaceutical preparation comprising Factor VIII, a sulfated glycosaminoglycan, and a hyaluronidase, wherein the Factor VIII, the sulfated glycosaminoglycan, and the hyaluronidase are present in a single composition at dosages sufficient to increase the bioavailability of Factor VIII after non-intravenous administration relative to the bioavailability when the same amount of Factor VIII is administered non-intravenously without the sulfated glycosaminoglycan and the hyaluronidase. 2. The pharmaceutical preparation of claim 1, wherein the Factor VIII is provided at a dosage ranging from about 10 IU/kg body weight to about 1,000 IU/kg body weight, the sulfated glycosaminoglycan is provided at a dosage ranging from about 0.01 mg/kg body weight to about 100 mg/kg body weight, and the hyaluronidase is provided at a dosage ranging from about 1 U/kg body weight to about 10,000 U/kg body weight. 3. The pharmaceutical preparation of claim 1, wherein the hyaluronidase is a human hyaluronidase. 4. The pharmaceutical preparation of claim 1, wherein the sulfated glycosaminoglycan is a heparin. 5. The pharmaceutical preparation of claim 4, wherein the heparin is unfractionated heparin.

Details for Patent 9,511,123

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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	⤷ Subscribe	2031-10-18
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	December 02, 2004	⤷ Subscribe	2031-10-18
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	October 26, 2004	⤷ Subscribe	2031-10-18
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	October 25, 2005	⤷ Subscribe	2031-10-18
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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