Claims for Patent: 10,799,564

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Summary for Patent: 10,799,564

Title:	Insulin premix formulation and product, methods of preparing same, and methods of using same
Abstract:	A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.
Inventor(s):	Joseph Chung Tak Wong, Sarah Elizabeth Lee
Assignee:	Baxter Healthcare SA , Baxter International Inc
Application Number:	US16/681,392

Details for Patent 10,799,564

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Baxter Healthcare Corporation	MYXREDLIN	insulin human	Injection	208157	June 20, 2019	⤷ Get Started Free	2039-11-12
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 10,799,564

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020227214	⤷ Get Started Free
United States of America	2021315976	⤷ Get Started Free
United States of America	2021052704	⤷ Get Started Free
United States of America	11707509	⤷ Get Started Free
United States of America	11033608	⤷ Get Started Free
>Country	>Patent Number	>Estimated Expiration

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