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Last Updated: July 10, 2020

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Patent: 9,964,545

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Summary for Patent: 9,964,545
Title:Methods for quantifying polypeptides using mass spectrometry
Abstract: A method for identifying a polypeptide a specimen can include (i) treating a specimen suspected of including an insulin with a base; (ii) extracting a first fraction of the treated specimen by solid phase extraction using a mixed mode or polymeric reversed-phase media and a first solvent including an acid; (iii) separating a component of the first fraction by liquid chromatography using a chromatographic surface including a hydrophobic surface group and one or more ionizable modifiers, and a second solvent including an acid; and (iv) analyzing the component of the first fraction by mass spectroscopy, thereby identifying the polypeptide, if present, using a signal corresponding to a sequence fragment ion from the polypeptide. The signal can correspond to an intact multiply charged precursor fragment selected in a first quadrupole and its corresponding sequence fragment ion selected in a final quadrupole.
Inventor(s): Chambers; Erin E. (North Brookfield, MA), Stapels; Martha (Bellingham, MA), Mather; Joanne (Millis, MA)
Assignee: WATERS TECHNOLOGIES CORPORATION (Milford, MA)
Application Number:15/447,838
Patent Claims:see list of patent claims

Details for Patent 9,964,545

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Mylan Pharms Inc SEMGLEE insulin glargine INJECTABLE;INJECTION 210605 001 2020-06-11   Start Trial WATERS TECHNOLOGIES CORPORATION (Milford, MA) 2032-04-18 RX search
Novo FIASP PENFILL insulin aspart SOLUTION;SUBCUTANEOUS 208751 003 2018-03-06   Start Trial WATERS TECHNOLOGIES CORPORATION (Milford, MA) 2032-04-18 RX search
Novo FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751 002 2018-03-06   Start Trial WATERS TECHNOLOGIES CORPORATION (Milford, MA) 2032-04-18 RX search
Novo FIASP insulin aspart SOLUTION;INTRAVENOUS, SUBCUTANEOUS 208751 001 2018-03-06   Start Trial WATERS TECHNOLOGIES CORPORATION (Milford, MA) 2032-04-18 RX search
Eli Lilly And Co BASAGLAR insulin glargine SOLUTION;SUBCUTANEOUS 205692 001 2016-06-17   Start Trial WATERS TECHNOLOGIES CORPORATION (Milford, MA) 2032-04-18 RX search
Novo Nordisk LEVEMIR insulin detemir INJECTABLE; INJECTION 021878 001 2005-10-19   Start Trial WATERS TECHNOLOGIES CORPORATION (Milford, MA) 2032-04-18 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

International Patent Family for US Patent 9,964,545

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