Claims for Patent: 10,398,669

Summary for Patent: 10,398,669

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:	15/700,258
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,398,669
Patent Claims:	1. A liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof; a stabilizing agent comprising tromethamine; not more than 2% liothyronine (T3); and water; wherein the formulation retains at least about 95% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for 12 months at 25.+-.2.degree. C., and retains at least about 95% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for 2 months at 40.+-.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 5 mcg/mL to about 500 mcg/mL. 4. The formulation of claim 1, wherein the tromethamine is present at a concentration of about 1 mg/mL to about 50 mg/mL. 5. The formulation of claim 1, wherein the stabilizing agent comprises a salt of iodine. 6. The formulation of claim 5, wherein the salt of iodine is sodium iodide or potassium iodide. 7. The formulation of claim 6, wherein the salt of iodine is sodium iodide which is present at a concentration of about 10 mcg/mL to about 500 mcg/mL. 8. The formulation of claim 1, wherein the formulation has a pH of from about 9.0 to about 11.5. 9. The formulation of claim 8, wherein the formulation has a pH of from about 9.8 to about 10.8. 10. The formulation of claim 1, wherein the formulation contains not more than 1.5% liothyronine (T3). 11. The formulation of claim 1, wherein the formulation contains not more than 1.0% liothyronine (T3). 12. The formulation of claim 1, wherein the formulation contains not more than 5.0% total impurities. 13. The formulation of claim 1, wherein the formulation contains not more than 2.5% total impurities. 14. The formulation of claim 1, wherein the formulation retains at least about 90% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for at least 18 months at 25.+-.2.degree. C. 15. The formulation of claim 1, wherein the formulation retains at least about 90% of the initial concentration of levothyroxine or pharmaceutically acceptable salt thereof after storage for at least 24 months at 25.+-.2.degree. C. 16. The formulation of claim 1, wherein the formulation does not contain a buffer. 17. The formulation of claim 1, wherein the formulation is a ready-to-use formulation contained within a vial, ampoule, cartridge, syringe, or bag.