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Last Updated: April 25, 2024

Claims for Patent: 9,782,376


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Summary for Patent: 9,782,376
Title:Levothyroxine liquid formulations
Abstract: The present invention is directed to a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes tromethamine, sodium iodide, and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use.
Inventor(s): Usayapant; Arunya (Mundelein, IL), Ibrahim; Basma M. (Lincolnshire, IL)
Assignee: Fresenius Kabi USA LLC (Lake Zurich, IL)
Application Number:15/366,864
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,782,376
Patent Claims: 1. A liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof; about 1 mg/mL to about 50 mg/mL of tromethamine; about 10 mcg/mL to about 500 mcg/mL of sodium iodide; and water; wherein the formulation has a pH of about 9.0 to about 11.5, and wherein the formulation is stable for at least 12 months at 25.+-.2.degree. C.

2. The formulation of claim 1, wherein levothyroxine or a pharmaceutically acceptable salt thereof is levothyroxine sodium.

3. The formulation of claim 2, wherein levothyroxine sodium is present at a concentration of from about 20 mcg/mL to about 100 mcg/mL.

4. The formulation of claim 3, wherein levothyroxine sodium is present at a concentration of about 20 mcg/mL, about 40 mcg/mL, or about 100 mcg/mL.

5. The formulation of claim 1, wherein tromethamine is present at a concentration of about 5 mg/mL to about 20 mg/mL.

6. The formulation of claim 5, wherein tromethamine is present at a concentration of about 10 mg/mL.

7. The formulation of claim 1, wherein sodium iodide is present at a concentration of about 100 mcg/mL to about 300 mcg/mL.

8. The formulation of claim 7, wherein sodium iodide is present at a concentration of about 140 mcg/mL.

9. The formulation of claim 1, further comprising an isotonicity adjuster.

10. The formulation of claim 9, wherein the isotonicity adjuster is sodium chloride.

11. The formulation of claim 1, further comprising a pH adjuster.

12. The formulation of claim 11, wherein the pH adjuster is selected from the group consisting of hydrochloric acid, sodium hydroxide and combinations thereof.

13. The formulation of claim 1, wherein the formulation has a pH of from about 9.8 to about 10.8.

14. The formulation of claim 1, wherein the formulation contains not more than 1.0% liothyronine (T3).

15. The formulation of claim 1, wherein the formulation contains not more than 2.5% total impurities.

16. The formulation of claim 1, wherein the formulation is a ready-to-use formulation contained within a flint colored molded glass vial.

17. The formulation of claim 1, wherein the formulation is stable for at least 18 months at 25.+-.2.degree. C.

18. A liquid formulation comprising (a) levothyroxine or a pharmaceutically acceptable salt thereof in a concentration of about 20 mcg/mL to about 100 mcg/mL; (b) tromethamine in a concentration of about 5 mg/mL to about 20 mg/mL; (c) sodium iodide in a concentration of about 100 mcg/mL to about 300 mcg/mL; (c) sodium chloride; and (d) water; wherein the formulation has a pH of about 9.8 to about 10.8, and wherein the formulation is stable for at least 12 months at 25.+-.2.degree. C.

19. The formulation of claim 18, wherein levothyroxine or a pharmaceutically acceptable salt thereof is levothyroxine sodium.

20. The formulation of claim 18, wherein the formulation contains not more than 1.0% liothyronine (T3).

21. The formulation of claim 18, wherein the formulation contains not more than 2.5% total impurities.

22. The formulation of claim 18, wherein the formulation is a ready-to-use formulation contained within a flint colored molded glass vial.

23. The formulation of claim 18, wherein the formulation is stable for at least 18 months at 25.+-.2.degree. C.

24. A liquid formulation comprising (a) levothyroxine sodium in a concentration of about 20 mcg/mL to about 100 mcg/mL; (b) tromethamine in a concentration of about 10 mg/mL; (c) sodium iodide in a concentration of about 140 mcg/mL; (c) sodium chloride; and (d) water; wherein the formulation has a pH of about 9.8 to about 10.8, and wherein the formulation is stable for at least 12 months at 25.+-.2.degree. C.

25. The formulation of claim 24, wherein the formulation is a ready-to-use formulation comprising levothyroxine sodium in a concentration of about 20 mcg/mL in a volume of about 5 mL and is contained within a flint colored molded glass vial.

26. The formulation of claim 25, wherein the formulation is stable for at least 18 months at 25.+-.2.degree. C.

27. The formulation of claim 24, wherein the formulation is a ready-to-use formulation comprising levothyroxine sodium in a concentration of about 40 mcg/mL in a volume of about 5 mL and is contained within a flint colored molded glass vial.

28. The formulation of claim 27, wherein the formulation is stable for at least 18 months at 25.+-.2.degree. C.

29. The formulation of claim 24, wherein the formulation is a ready-to-use formulation comprising levothyroxine sodium in a concentration of about 100 mcg/mL in a volume of about 5 mL and is contained within a flint colored molded glass vial.

30. The formulation of claim 29, wherein the formulation is stable for at least 18 months at 25.+-.2.degree. C.

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