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Last Updated: March 29, 2024

Claims for Patent: 9,737,600


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Summary for Patent: 9,737,600
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:15/193,415
Patent Claims:1. An aqueous pharmaceutical composition comprising: (i) adalimumab; (ii) a stabilizer; and (iii) a salt; selected from sodium chloride, sodium sulfate and potassium chloride; wherein the composition is free of buffer, has a pH of about 5 to about 6, and is stable for one week at 40.degree. C. or two weeks at 25.degree. C.

2. The composition of claim 1 comprising polyol.

3. The composition of claim 1 comprising surfactant.

4. The composition of claim 1 comprising polyol and surfactant.

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

6. The composition of claim 5, wherein the amino acid is glycine, arginine or a combination thereof.

7. The composition of claim 1, wherein the salt is selected from sodium chloride and sodium sulfate.

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

9. The composition of claim 8, wherein the dosage is about 40 mg and results in less pain upon administration to a subject in comparison to an adalimumab composition having a buffer comprising citrate.

Details for Patent 9,737,600

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
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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