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Last Updated: April 19, 2024

Claims for Patent: 8,349,321

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Summary for Patent: 8,349,321

Title:	Immunoglobulin formulation and method of preparation thereof
Abstract:	A stable aqueous pharmaceutical formulation comprising a therapeutically effective amount of an antibody, polysorbate 80, a buffer which inhibits polysorbate oxidation is described along with methods of making the preparation. Also described are formulations with high antibody concentrations which maintain fixed volumes and which may be used on patients of variable weight.
Inventor(s):	Burke; David J. (Oakland, CA), Buckley; Shaun E. (San Francisco, CA), Lehrman; Sherwood Russ (Los Altos, CA), O\'Connor; Barbara Horsey (San Carlos, CA), Callaway; James (San Diego, CA), Phillips; Christopher P. (Doyleston, PA)
Assignee:	Elan Pharmaceuticals, Inc. (South San Francisco, CA)
Application Number:	12/572,978
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,349,321
Patent Claims:	1. A stable, aqueous pharmaceutical formulation comprising 20 mg/ml of natalizumab, about 10 mM sodium phosphate buffer, 8.18 mg/ml of sodium chloride, and 0.2 mg/ml of polysorbate 80, and wherein the formulation has a pH of 6.1. 2. The formulation of claim 1, wherein the formulation is isotonic. 3. The formulation of claim 1, wherein the composition is stable when stored at about 5.degree. C. to about 8.degree. C. for greater than 6 months. 4. An article of manufacture comprising a container holding the stable formulation of claim 1.

Details for Patent 8,349,321

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004	⤷ Try a Trial	2023-02-10
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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