Last Updated: June 23, 2026

Claims for Patent: 5,840,680

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Summary for Patent: 5,840,680

Title:	ASP.sup.B28 insulin crystals
Abstract:	The present invention relates to insulin crystals comprising ASP.sup.B28 and protamine, and pharmaceutical preparations containing same. The crystals and preparations exhibit rapid onset and prolonged activity when administered in vivo.
Inventor(s):	Balschmidt; Per (Esper.ae butted.rde, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	08/763,853
Patent Claims:	1. Crystals comprising Asp.sup.B28 human insulin, protamine, and a member selected from the group consisting of phenol, a m-cresol, or a combination thereof. 2. Crystals as defined in claim 1, further comprising zinc. 3. A pharmaceutical formulation comprising crystals as defined in claim 1. 4. A pharmaceutical formulation comprising crystals as defined in claim 2. 5. A pharmaceutical formulation as defined in claim 3, wherein said crystals are suspended in an aqueous medium. 6. A pharmaceutical formulation as defined in claim 4, wherein said crystals are suspended in an aqueous medium. 7. A pharmaceutical formulation as defined in claim 3, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof. 8. A pharmaceutical formulation as defined in claim 4, further comprising a member selected from the group consisting of an isotonic agent, a buffer, and a combination thereof. 9. A pharmaceutical formulation as defined in claim 7, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate. 10. A pharmaceutical formulation as defined in claim 8, wherein said isotonic agent is selected from the group consisting of sodium chloride and glycerol and said buffer comprises disodium monohydrogen phosphate. 11. A pharmaceutical formulation as defined in claim 3, further comprising dissolved Asp.sup.B28 human insulin. 12. A pharmaceutical formulation as defied in claim 4, further comprising dissolved Asp.sup.B28 human insulin. 13. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical composition as defined in claim 3. 14. A method of treating a patient suffering from diabetes mellitus, said method comprising administering to said patient a pharmaceutical composition as defined in claim 4.

Details for Patent 5,840,680

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	November 01, 2001	⤷ Start Trial	2016-12-11
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	May 03, 2002	⤷ Start Trial	2016-12-11
Novo Nordisk Inc.	NOVOLOG MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810	August 26, 2008	⤷ Start Trial	2016-12-11
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 5,840,680

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Country	Patent Number	Estimated Expiration
Austria	E176482	⤷ Start Trial
Australia	6995794	⤷ Start Trial
Germany	10199011	⤷ Start Trial
Germany	122006000015	⤷ Start Trial
Germany	122006000017	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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