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Last Updated: March 28, 2024

Claims for Patent: 9,682,145


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Summary for Patent: 9,682,145
Title:Stable aqueous formulations of adalimumab
Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.
Inventor(s): Manning; Mark (Johnstown, CO), Payne; Robert W. (Fort Collins, CO)
Assignee: Coherus Biosciences, Inc. (Redwood City, CA)
Application Number:15/155,832
Patent Claims:1. A buffered aqueous pharmaceutical composition comprising: (i) adalimumab; (ii) a buffer consisting solely of histidine; and (iii) a polyol; wherein the composition does not contain surfactant.

2. The composition of claim 1, wherein the polyol is mannitol, sorbitol or trehalose.

3. The composition of claim 2, wherein the polyol is sorbitol.

4. The composition of claim 1, wherein the composition does not contain an amino acid other than histidine.

5. The composition of claim 1 further comprising an amino acid selected from the group consisting of glycine, alanine, glutamate, arginine, methionine, and combinations thereof.

6. The composition of claim 1 further comprising sodium chloride or sodium sulfate at a concentration of up to 150 mM.

7. The composition of claim 1, wherein the composition has a concentration of adalimumab of 30 to 50 mg/ml.

8. The composition of claim 7, wherein the concentration of adalimumab is about 50 mg/ml.

9. The composition of claim 1 having osmolality of about 180 to 420 mOsM; wherein the composition is suitable for administration to a subject as a single dosage; the composition has a concentration of adalimumab of 30 to 50 mg/ml; and the dosage contains 10 to 80 mg of adalimumab.

10. The composition of claim 9 further comprising sodium chloride at a concentration of up to 100 mM and wherein the polyol is sorbitol.

11. The composition of claim 9 further comprising sodium chloride at a concentration of up to 100 mM and wherein the polyol is mannitol.

12. The composition of claim 9, wherein the composition does not contain an amino acid other than histidine.

13. The composition of claim 9 further comprising an amino acid selected from the group consisting of glycine, alanine, glutamate, arginine, methionine, and combinations thereof.

14. The composition of claim 9 further comprising sodium chloride or sodium sulfate at a concentration of up to 150 mM.

15. The composition of claim 9, wherein the dosage is about 40 mg and has less tendency to cause pain upon administration to a subject in comparison to an adalimumab composition having a buffer that comprises citrate.

16. A buffered aqueous pharmaceutical composition comprising: (i) adalimumab; (ii) a buffer consisting solely of histidine; and (iii) a stabilizer, consisting essentially of: (a) an amino acid selected from glycine, alanine, glutamate, arginine, methionine, and combinations thereof; and (b) a polyol; wherein the composition does not contain surfactant.

17. The composition of claim 16, wherein the amino acid selected from the group consisting of glycine, arginine, methionine, and combinations thereof.

18. The composition of claim 16, wherein the amino acid is glycine.

19. The composition of claim 18, further comprising a salt, selected from sodium chloride and sodium sulfate, present at a concentration of up to 150 mM.

20. The composition of claim 16, wherein the polyol is mannitol, sorbitol or trehalose.

21. The composition of claim 20, wherein the polyol is sorbitol.

22. The composition of claim 16, wherein the composition has a concentration of adalimumab of 30 to 50 mg/ml.

23. The composition of claim 22, wherein the concentration of adalimumab is about 50 mg/ml.

24. The composition of claim 16 having osmolality of 180 to 420 mOsM; wherein the composition is suitable for administration to a subject as a single dosage; the composition has a concentration of adalimumab of 30 to 50 mg/ml; and the dosage contains 10 to 80 mg of adalimumab.

25. The composition of claim 24, wherein the concentration of adalimumab is about 50 mg/ml.

26. The composition of claim 24, wherein the amino acid is glycine.

27. The composition of claim 26 further comprising sodium chloride at a concentration of up to 100 mM and wherein the polyol is sorbitol.

28. The composition of claim 26 further comprising sodium chloride present at a concentration of up to 100 mM and wherein the polyol is mannitol.

29. The composition of claim 28, wherein the dosage is about 40 mg and has less tendency to cause pain upon administration to a subject in comparison to an adalimumab composition having a buffer that comprises citrate.

Details for Patent 9,682,145

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 12/31/2002 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 02/21/2008 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 04/24/2013 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 09/23/2014 ⤷  Try a Trial 2039-02-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 11/23/2015 ⤷  Try a Trial 2039-02-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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