Claims for Patent: 8,900,577

Summary for Patent: 8,900,577

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:	Biogen Idec Ma Inc. (Cambridge, MA)
Application Number:	13/605,590
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,900,577
Patent Claims:	1. A stable, aqueous pharmaceutical formulation comprising from about 20 mg/ml to about 150 mg/ml of natalizumab, polysorbate 80 present in an amount of about 0.001% to 2% (w/v), about 10 mM phosphate buffer, and about 140 mM NaCl. 2. The formulation of claim 1, comprising about 150 mg/ml natalizumab. 3. The formulation of claim 1, wherein the formulation is isotonic. 4. The formulation of claim 1, wherein the formulation is stable at a temperature of 2.degree. C. to 8.degree. C. for at least 6 months. 5. The formulation of claim 1., wherein the formulation has a pH of 3.0 to 7.0. 6. The formulation of claim 4, wherein the formulation has a pH of 5.5 to 6.5. 7. An article of manufacture comprising a container holding the stable, aqueous pharmaceutical formulation of claim 1. 8. An article of manufacture comprising a container holding the stable, aqueous pharmaceutical formulation of claim 2. 9. An article of manufacture comprising a container holding the stable, aqueous pharmaceutical formulation of claim 3. 10. An article of manufacture comprising a container holding the stable, aqueous pharmaceutical formulation of claim 4. 11. An article of manufacture comprising a container holding the stable, aqueous pharmaceutical formulation of claim 5. 12. An article of manufacture comprising a container holding the stable, aqueous pharmaceutical formulation of claim 6. 13. A stable, aqueous pharmaceutical formulation comprising about 150 mg/ml of natalizumab, polysorbate 80 present in an amount of about 0.001% to 2% (w/v), about 10 mM phosphate buffer, and about 140 mM NaCl. 14. An article of manufacture comprising a container holding the stable, aqueous pharmaceutical formulation of claim 13.

Details for Patent 8,900,577

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