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Last Updated: March 28, 2024

Claims for Patent: 10,293,049


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Summary for Patent: 10,293,049
Title:Etanercept formulations stabilized with amino acids
Abstract: The invention provides stabilized aqueous pharmaceutical etanercept compositions stabilized with an amino acid and 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:13/654,735
Patent Claims:1. A stable aqueous pharmaceutical composition comprising about 50 mg/ml etanercept, and 100-120 mM glutamate, wherein the composition has a pH of about 6.0 to 6.6, and wherein the composition is free or essentially free of arginine.

2. The composition of claim 1, further comprising one or more additional components selected from: a buffer; a tonicity modifier, and an excipient.

3. The composition of claim 2 wherein the formulation comprises less than 6 wt. % sucrose; optionally up to about 100 mM NaCl; and about 1 to about 30 mM sodium phosphate buffer.

4. The composition of claim 1 eliciting long term storage stability as characterized by: an HIC analysis at M.sub.3 or T.sub.2 or T.sub.4 wherein the amount of the composition represented by peak 2 of the HIC chromatogram is greater than or equal to 95 wt. %; and wherein, if peak 3 is present on the HIC chromatogram, the amount of the composition represented by peak 3 is less than or equal to 3 wt. %.

5. The composition of claim 1 having no more than, on average, about 10,000 subvisible particles per mL having a size greater than 5 .mu.m.

6. The composition of claim 1 further comprising about 0 to 3 wt. % sucrose.

7. The composition of claim 1 further comprising less than 4 wt. % sucrose, and about 10 to 30 mM sodium phosphate buffer; and having a pH of about 6.3 to 6.5.

8. The composition of claim 1 further comprising 100 mM glutamate; less than 2 wt. % sucrose, about 100 mM NaCl; about 10-30 mM sodium phosphate buffer; and having a pH of about 6.3 to 6.5.

9. The composition of claim 1, wherein the composition elicits long term storage stability as characterized by an HIC chromatogram, at M.sub.3 or T.sub.2 or T.sub.4, in which (i) peak 3 is absent, or essentially absent and (ii) peak 2 represents greater than 95 weight % of the composition; and peak 1 represents less than 3 wt. %.

10. The composition of claim 1, wherein the composition elicits long term storage stability as characterized by an SEC chromatogram, at M.sub.3 or T.sub.2 or T.sub.4, containing essentially no peak corresponding to aggregate(s) and a monomer content of at least 95 wt % of the composition and fragment 3 content less than 5 wt. % of the composition.

11. The composition of claim 1, wherein the composition elicits long term storage stability as characterized by SEC analysis at M.sub.3 or T.sub.2 or T.sub.4 of: monomer content greater than 90%; aggregates content of less than 3 wt %; and fragment 3 content less than 5 wt %.

12. The composition of claim 1, wherein the composition elicits long term storage stability as characterized by HIC analysis at M.sub.3 or T.sub.2 or T.sub.4, 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. %.

13. The composition of claim 6, having no more than, on average, about 10,000 subvisible particles per mL having a size greater than 5 .mu.m.

14. The composition of claim 7, having no more than, on average, about 10,000 subvisible particles per mL having a size greater than 5 .mu.m.

15. The composition of claim 8, having no more than, on average, about 10,000 subvisible particles per mL having a size greater than 5 .mu.m.

Details for Patent 10,293,049

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 2039-06-19
Immunex Corporation ENBREL etanercept For Injection 103795 05/27/1999 ⤷  Try a Trial 2039-06-19
Immunex Corporation ENBREL etanercept Injection 103795 09/27/2004 ⤷  Try a Trial 2039-06-19
Immunex Corporation ENBREL etanercept Injection 103795 02/01/2007 ⤷  Try a Trial 2039-06-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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