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Generated: August 18, 2019

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Patent: 9,683,050

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Summary for Patent: 9,683,050
Title:Stable compositions of high-concentration allotype-selected antibodies for small-volume administration
Abstract: Disclosed are methods, compositions and uses of high concentration antibody or immunoglobulin formulations for subcutaneous, intramuscular, transdermal or other local (regional) administration, in a volume of than 3, less than 2 or less than 1 ml. Preferably, the formulation contains a high concentration formulation (HCF) buffer comprising phosphate, citrate, polysorbate 80 and mannitol at a pH of about 5.2. The formulation more preferably comprises at least 100, 150, 200, 250 mg/ml or 300 mg/ml of antibody. The methods for preparing the high concentration formulation include ultrafiltration and diafiltration to concentrate the antibody and exchange the medium for HCF buffer. Other embodiments concern use of non-G1m1 (nG1m1) allotype antibodies, such as G1m3 and/or a nG1m1,2 antibodies. The nG1m1 antibodies show decreased immunogenicity compared to G1m1 antibodies.
Inventor(s): Zeng; Li (Edison, NJ), Mitra; Rohini (Brigdewater, NJ), Rossi; Edmund A. (Woodland Park, NJ), Hansen; Hans J. (Picayune, MS), Goldenberg; David M. (Mendham, NJ)
Assignee: Immunomedics, Inc. (Morris Plains, NJ)
Application Number:14/876,200
Patent Claims:see list of patent claims

Details for Patent 9,683,050

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 004 2015-01-23 ➤ Sign Up Immunomedics, Inc. (Morris Plains, NJ) 2031-05-02 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23 ➤ Sign Up Immunomedics, Inc. (Morris Plains, NJ) 2031-05-02 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23 ➤ Sign Up Immunomedics, Inc. (Morris Plains, NJ) 2031-05-02 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23 ➤ Sign Up Immunomedics, Inc. (Morris Plains, NJ) 2031-05-02 RX Orphan search
Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source

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International Patent Family for US Patent 9,683,050

Country Patent Number Publication Date
United States of America 6183744 Feb 06, 2001
United States of America 6306393 Oct 23, 2001
United States of America 6761680 Jul 13, 2004
United States of America 6786858 Sep 07, 2004
United States of America 6820318 Nov 23, 2004
United States of America 6997862 Feb 14, 2006
United States of America 7008368 Mar 07, 2006
Country Patent Number Publication Date

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Serving hundreds of leading biopharmaceutical companies globally:

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Argus Health

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