Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt

Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Patent: 9,580,506

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Summary for Patent: 9,580,506
Title:Potency assays for antibody drug substance binding to an Fc receptor
Abstract: The invention relates to a method of characterizing an antibody, which method is suitable as a potency assay for batch release of a pharmaceutical composition comprising an antibody, specifically for use when applying for marketing authorization for said pharmaceutical composition. The assay provided is a method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor.
Inventor(s): Gerarda Havenith; Catharina Emanuele (Bodegraven, NL), Vink; Tom (Alphen aan den Rijn, NL), Berkel; Patrick Van (Utrecht, NL), Parren; Paul (Odijk, NL)
Assignee: GENMAB A/S (Copenhagen, DK)
Application Number:11/989,064
Patent Claims:see list of patent claims

Details for Patent 9,580,506

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Genentech Inc HERCEPTIN HYLECTA trastuzumab; hyaluronidase-oysk INJECTABLE;SUBCUTANEOUS 761106 001 2019-02-28   Start Trial GENMAB A/S (Copenhagen, DK) 2039-02-26 RX search
Genentech Inc RITUXAN HYCELA rituximab; hyaluronidase (human recombinant) SOLUTION;SUBCUTANEOUS 761064 002 2017-06-22   Start Trial GENMAB A/S (Copenhagen, DK) 2039-02-26 RX Orphan search
Genentech Inc RITUXAN HYCELA rituximab; hyaluronidase (human recombinant) SOLUTION;SUBCUTANEOUS 761064 001 2017-06-22   Start Trial GENMAB A/S (Copenhagen, DK) 2039-02-26 RX Orphan search
Biogen ZINBRYTA daclizumab INJECTABLE;INJECTION 761029 001 2017-05-26   Start Trial GENMAB A/S (Copenhagen, DK) 2039-02-26 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Medtronic
Mallinckrodt
Express Scripts
McKinsey

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