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Last Updated: January 28, 2022

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Claims for Patent: 9,649,383

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Summary for Patent: 9,649,383
Title:Liquid formulations for TNFR:Fc fusion proteins
Abstract: The invention provides stable liquid formulations for a recombinant biopharmaceutical protein comprising a soluble form of the human p75 TNF receptor fused to an Fe domain of a human immunoglobulin protein (TNFR:Fc). Typically, biopharmaceutical proteins such as monoclonal antibodies (mAbs) and immunoglobulin fusion proteins (e.g., immunoadhesion proteins) are produced by recombinant DNA technology in mammalian cell expression systems. In order to guarantee the reproducible clinical performance of a biopharmaceutical product, manufacturers have to deliver a product of consistent and reproducible quality.
Inventor(s): Kashi; Ramesh S. (Warren, NJ), Patel; Shona P. (Florham Park, NJ), Mittal; Sarita (Bridgewater, NJ), Basarkar; Ashwin (Springfield, NJ), Shi; Shuai (Summit, NJ)
Assignee: Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:14/443,557
Patent Claims:1. A stable liquid pharmaceutical formulation comprising 50 mg/ml etanercept, a citrate-phosphate buffer, 100 or 125 mM sodium chloride, L-histidine, and sucrose, pH 6.0-6.5.

2. The formulation of claim 1, wherein the amino acid is L-histidine at a concentration of 25 mM.

3. The formulation of claim 2, wherein the sugar is present at a concentration of about 1%.

4. The formulation of claim 1, comprising 50 mg/ml etanercept, a 25 mM citrate-phosphate buffer pH 6.3, 100 mM sodium chloride, 25 mM L-histidine and 1% sucrose.

5. The formulation of claim 1 wherein etanercept exhibits stability over at least about 12 months.

Details for Patent 9,649,383

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Immunex Corporation ENBREL etanercept For Injection 103795 1998-11-02 ⤷  Sign up for a Free Trial 2039-02-26
Immunex Corporation ENBREL etanercept For Injection 103795 1999-05-27 ⤷  Sign up for a Free Trial 2039-02-26
Immunex Corporation ENBREL etanercept Injection 103795 2004-09-27 ⤷  Sign up for a Free Trial 2039-02-26
Immunex Corporation ENBREL etanercept Injection 103795 2007-02-01 ⤷  Sign up for a Free Trial 2039-02-26
Immunex Corporation ENBREL MINI etanercept Injection 103795 2017-09-14 ⤷  Sign up for a Free Trial 2039-02-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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