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This backstop function makes regulatory exclusivities strategically essential in P.IV litigation planning

By slowing down the movement of food through the stomach, semaglutides may contribute to the development of gastroparesis and other gastrointestinal adverse events

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A method for isolating a peptide, the method including purification of a GLP-1 peptide from a mixture comprising said peptide and related impurities via a cation exchange chromatography process, the cation exchange chromatography process comprising the steps of:separating said GLP-1 peptide and said related impurities of said mixture by elution in a solution consisting essentially of an organic modifier, water, optionally a salt component, and optionally a buffer, with a linear or step gradient or isocratically in salt component and/or with a linear or step pH-gradient or at a constant pH-value, wherein the pH-gradient or pH-value should be in the range where said peptide has a positive local or overall net charge different from the local or overall positive net charge of said related impurities so as to remove said related impurities;and subsequently, if necessary, subjecting to analytical tests and/or further purification, and isolating said peptide in a conventional manner, wherein the ratio of organic modifier to water, on a weight percent basis, is from 1:99 to 99:1, such as 1:99 to 80:20, 20:80 to 80:20, 30:70 to 70:30, 35:50 to 50:35, or 40:50 to 50:40

O que se vende hoje como retatrutida, portanto, anterior prpria existncia legal do medicamento