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Last Updated: March 28, 2024

Claims for Patent: 10,493,151


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Summary for Patent: 10,493,151
Title:Etanercept formulations stabilized with sodium chloride
Abstract: The invention provides stabilized aqueous pharmaceutical etanercept compositions suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.
Inventor(s): Manning; Mark (Johnstown, CO), Murphy; Brian (Fort Collins, CO)
Assignee: Coherus BioSciences, Inc. (Redwood City, CA)
Application Number:13/654,795
Patent Claims:1. A stable aqueous etanercept formulation comprising 25 to 75 mg/ml of etanercept, up to 150 mM sodium chloride, 1 to 30 mM sodium phosphate, and 3 to 5 wt. % sucrose, wherein the formulation is free of arginine.

2. The formulation of claim 1 wherein the formulation elicits long term storage stability as characterized by at least one of: SEC analysis at M3 or T2 or T4 of: monomer content greater than 90%; aggregates content of less than 3 wt. %; and fragment 3 content less than 5 wt. %.

3. The aqueous etanercept formulation of claim 1, wherein the amount of sodium phosphate is 25 mM.

4. The formulation of claim 3 wherein etanercept is at a concentration of 50 mg/ml and sodium chloride is at a concentration of 75 mM.

5. The formulation of claim 1 wherein sodium phosphate is at a concentration of 10 mM.

6. A stable aqueous etanercept formulation comprising 25 to 75 mg/ml of etanercept, up to 150 mM sodium chloride, 10 to 25 mM sodium phosphate, and 3 to 5 wt. % trehalose, wherein the formulation is free of arginine.

7. The formulation of claim 6 wherein etanercept is at a concentration of 50 mg/ml, sodium chloride is at a concentration of 75 mM and sodium phosphate is at a concentration of 25 mM.

8. The formulation of claim 1 wherein the formulation elicits long term storage stability as characterized by at least one of: HIC analysis at M3 or T2 or T4 wherein the amount of the composition represented by peak 1 of the HIC chromatogram is less than 3 wt. %; the amount of the composition represented by peak 2 of the HIC chromatogram is greater than 80 wt. %; and the amount of the composition represented by peak 3 of the HIC chromatogram is less than 20 wt. %.

9. The formulation of claim 1 wherein the formulation, at M3 or T2 or T4, elicits long term storage stability that meets the following criteria: (A) an SEC analysis of: monomer content greater than 90%; aggregates content of less than 3 wt. %; and fragment 3 content less than 5 wt. %; and (B) an HIC analysis wherein the amount of the composition represented by peak 1 of the HIC chromatogram is less than 3 wt. %; the amount of the composition represented by peak 2 of the HIC chromatogram is greater than 80 wt. %; and the amount of the composition represented by peak 3 of the HIC chromatogram is less than 20 wt. %.

10. The formulation of claim 1, wherein the formulation has a pH of 6.0 to 6.6.

11. The formulation of claim 6, wherein the formulation has a pH of 6.0 to 6.6.

Details for Patent 10,493,151

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Immunex Corporation ENBREL etanercept For Injection 103795 11/02/1998 ⤷  Try a Trial 2039-12-23
Immunex Corporation ENBREL etanercept For Injection 103795 05/27/1999 ⤷  Try a Trial 2039-12-23
Immunex Corporation ENBREL etanercept Injection 103795 09/27/2004 ⤷  Try a Trial 2039-12-23
Immunex Corporation ENBREL etanercept Injection 103795 02/01/2007 ⤷  Try a Trial 2039-12-23
Immunex Corporation ENBREL MINI etanercept Injection 103795 09/14/2017 ⤷  Try a Trial 2039-12-23
Immunex Corporation ENBREL etanercept Injection 103795 ⤷  Try a Trial 2039-12-23
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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