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Last Updated: April 25, 2024

Claims for Patent: 4,364,861

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Summary for Patent: 4,364,861

Title:	Blood-coagulation-promoting products and methods of preparing them
Abstract:	Blood-coagulation-promoting products substantially free of thrombin are prepared from human blood plasma by contacting a human blood plasma fraction containing coagulation Factors II, VII, IX and X with an anion exchanger to adsorb the coagulation Factors, which are subsequently eluted from the anion exchanger. The eluate is treated to generate a substance having Factor VIII Inhibitor Bypassing Activity and being substantially free of thrombin, and activated Factor X.
Inventor(s):	Mitra; Gautam (Kensington, CA), Coan; Michael H. (El Cerrito, CA), Wada; Shohachi (Oakland, CA)
Assignee:	Cutter Laboratories, Inc. (Berkeley, CA)
Application Number:	06/153,341
Patent Claims:	1. A pharmaceutical preparation free of heparin, comprising coagulation Factors II, VII, IX, and X and having Factor VIII Inhibitor Bypassing Activity (FEIB-activity) wherein the FEIBA:Factor II ratio, the FEIBA:Factor VII ratio, the FEIBA:Factor IX ratio, and the FEIBA:Factor X ratio, are about 10:1 to 0.1:1, respectively, and wherein the FEIBA:activity is at least about 60 Units per milliliter and wherein the FEIBA:thrombin ratio is at least about 50:1. 2. The preparation of claim 1 wherein the FEIBA:Factor Xa ratio is at least about 45:1. 3. The preparation of claim 1 wherein the FEIBA:Factor II ratio is about 1.5:1 to 6:1, the FEIBA:Factor VII ratio is about 0.5:1 to 1.5:1, the FEIBA:Factor IX ratio is about 1:1 to 2:1, and the FEIBA:Factor X ratio is about 1.5:1 to 7:1. 4. The preparation of claim 1 which contains less than 1.5 Units per millilter of thrombin activity. 5. The preparation of claim 1 which contains less than 0.5 Units per milliliter of thrombin and the FEIBA:thrombin ratio is about 1000:1 or higher. 6. A pharmaceutical preparation free of detectable thrombin and heparin, comprising coagulation Factors II, VII, IX, and X and having Factor VIII Inhibitor Bypassing Activity (FEIB-activity) wherein the FEIBA:Factor II ratio is about 1.5:1 to 6:1, the FEIBA:Factor VII ratio is about 0.5:1 to 1.5:1, the FEIBA:Factor IX ratio is about 1:1 to 2:1, and the FEIBA:Factor X ratio is about 1.5:1 to 7:1.

Details for Patent 4,364,861

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Baxalta Us Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	12/21/1979	⤷ Try a Trial	2040-01-28
Baxalta Us Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	07/31/2000	⤷ Try a Trial	2040-01-28
Baxalta Us Inc.	AUTOPLEX, FEIBA NF, FEIBA VH	anti-inhibitor coagulant complex	For Injection	101447	08/11/2005	⤷ Try a Trial	2040-01-28
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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