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Last Updated: December 22, 2024

Claims for Patent: 5,866,538

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Summary for Patent: 5,866,538

Title:	Insulin preparations containing NaCl
Abstract:	Insulin preparations of superior chemical stability, comprising human insulin or an analogue or derivative thereof, glycerol and/or mannitol, and 5 to 100 mM of a halogenide are disclosed.
Inventor(s):	Norup; Elsebeth (Jyllinge, DK), Langkj.ae butted.r; Liselotte (Klampenborg, DK), Havelund; Svend (Bagsvaerd, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	08/879,991
Patent Claims:	1. A pharmaceutical formulation comprising: a polypeptide selected from the group consisting of human insulin, an analogue thereof, a derivative thereof, and combinations of any of the foregoing; glycerol, mannitol, or glycerol and mannitol; and 5 to 100 mM of a halogenide. 2. A pharmaceutical formulation according to claim 1, wherein the halogenide is an alkali or alkaline earth halogenide. 3. A pharmaceutical formulation according to claim 1, wherein said glycerol or mannitol is present at a concentration of 100 to 250 mM. 4. A pharmaceutical formulation according to claim 1, wherein said polypeptide is an analogue of human insulin selected from the group consisting of: (i) an analogue wherein position B28 is Asp, Lys, Leu, Val or Ala and position B29 is Lys or Pro; and (ii) des(B28-B30), des(B27) or des(B30) human insulin. 5. A pharmaceutical formulation according to claim 4, wherein said polypeptide is an analogue of human insulin wherein position B28 is Asp or Lys, and position B29 is Lys or Pro. 6. A pharmaceutical formulation according to claim 4, wherein said polypeptide is des(B30) human insulin. 7. A pharmaceutical formulation according to claim 1, wherein said halogenide is present at a concentration of 5 to 60 mM. 8. A pharmaceutical formulation according to claim 1, wherein said polypeptide is a derivative of human insulin having one or more lipophilic substituents. 9. A pharmaceutical formulation according to claim 8, wherein the insulin derivative is selected from the group consisting of B29-N.sup..epsilon. -myristoyl-des(B30) human insulin, B29-N.sup..epsilon. -palmitoyl-des(B30) human insulin, B29-N.sup..epsilon. -myristoyl human insulin, B29-N.sup..epsilon. -palmitoyl human insulin, B28-N.sup..epsilon. -myristoyl Lys.sup.B28 Pro.sup.B29 human insulin, B28-N.sup..epsilon. -palmitoyl-Lys.sup.B28 Pro.sup.B29 human insulin, B30-N.sup..epsilon. -myristoyl-Thr.sup.B29 Lys.sup.B30 human insulin, B30-N.sup..epsilon. -palmitoyl-Thr.sup.B29 Lys.sup.B30 human insulin, B29-N.sup..epsilon. -(N-palmitoyl-.gamma.-glutamyl)-des(B30) human insulin, B29-N.sup..epsilon. (N-lithocholyl-.gamma.-glutamyl)-des(B30) human insulin, B29-N.sup..epsilon. -(.omega.-carboxyheptadecanoyl)-des(B30) human insulin and B29-N.sup..epsilon. -(.omega.-carboxyheptadecanoyl) human insulin. 10. A pharmaceutical formulation according to claim 9, wherein the insulin derivative is B29-N.sup..epsilon. -myristoyl-des(B30) human insulin. 11. A pharmaceutical formulation according to claim 8, wherein said halogenide is present at a concentration of 10 to 100 mM. 12. A pharmaceutical formulation according to claim 1, comprising an insulin analogue as well as an insulin derivative. 13. A pharmaceutical formulation according to claim 1, wherein said polypeptide is present at a concentration of 60 to 3000 nmol/ml. 14. A pharmaceutical formulation according to claim 1, further comprising: 10 to 40 ug Zn/100 U insulin. 15. A pharmaceutical formulation according to claim 1, further comprising: 0 to 5 mg/ml of a phenolic compound. 16. A pharmaceutical formulation according to claim 15, comprising: 0. 5 to 4.0 mg/ml of m-cresol or 0.5 to 4.0 mg/ml of phenol, or a mixture thereof. 17. A pharmaceutical formulation according to claim 1, wherein the halogenide is sodium chloride.

Details for Patent 5,866,538

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	June 07, 2000	⤷ Subscribe	2016-06-20
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	January 19, 2001	⤷ Subscribe	2016-06-20
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	April 23, 2004	⤷ Subscribe	2016-06-20
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	October 31, 2013	⤷ Subscribe	2016-06-20
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	November 01, 2001	⤷ Subscribe	2016-06-20
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	May 03, 2002	⤷ Subscribe	2016-06-20
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

International Patent Family for US Patent 5,866,538

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Country	Patent Number	Estimated Expiration
South Africa	975470	⤷ Subscribe
World Intellectual Property Organization (WIPO)	9748414	⤷ Subscribe
Ukraine	49890	⤷ Subscribe
Russian Federation	2182015	⤷ Subscribe
Portugal	921812	⤷ Subscribe
Poland	330763	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration

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