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Last Updated: August 11, 2022

Claims for Patent: 9,757,416


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Summary for Patent: 9,757,416
Title:Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Abstract: The present invention discloses pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.
Inventor(s): Chan; Keith (Rockville, MD), Town; Winston (Hong Kong, CN), Kwok; David W. K. (Vancouver, CA), Stoynov; Nikolay Mintchev (Vancouver, CA)
Assignee: Panion & BF Biotech Inc. (TW)
Application Number:14/701,933
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,757,416
Patent Claims: 1. A method of treating hyperphosphatemia, comprising: administering one or more tablets comprising ferric citrate and a pharmaceutically acceptable carrier to a subject, the tablets prepared from a form of ferric citrate having a BET active surface area of at least about 16 m.sup.2/g; wherein the tablets are administered to provide up to 30 grams of ferric citrate to the subject per day.

2. The method of claim 1, wherein the subject has chronic kidney disease.

3. The method of claim 2, wherein the chronic kidney disease is selected from early-stage chronic kidney disease and mid-stage chronic kidney disease.

4. The method of claim 2, wherein the chronic kidney disease is late-stage chronic kidney disease.

5. The method of claim 4, wherein the subject is undergoing dialysis.

6. The method of claim 5, wherein the dialysis is selected from hemodialysis and peritoneal dialysis.

7. The method of claim 1, wherein the tablets are administered to provide 4 grams to 15 grams of ferric citrate to the subject per day.

8. The method of claim 1, wherein the tablets are administered to provide 2 grams to 12 grams of ferric citrate to the subject per day.

9. The method of claim 1, wherein the tablets are administered to provide 2 grams, 4 grams or 6 grams of ferric citrate to the subject per day.

10. The method of claim 1, wherein the tablets are administered to provide 1 gram of ferric citrate to the subject per day.

11. The method of claim 1, wherein the tablets each comprise 500 mg of ferric citrate.

12. A method of treating metabolic acidosis, comprising: administering one or more tablets comprising ferric citrate and a pharmaceutically acceptable carrier to a subject, the tablets prepared from a form of ferric citrate having a BET active surface area of at least about 16 m.sup.2/g; wherein the tablets are administered to provide up to 30 grams of ferric citrate to the subject per day.

13. The method of claim 12, wherein the subject has chronic kidney disease.

14. The method of claim 13, wherein the chronic kidney disease is selected from early-stage chronic kidney disease and mid-stage chronic kidney disease.

15. The method of claim 13, wherein the chronic kidney disease is late-stage chronic kidney disease.

16. The method of claim 15, wherein the subject is undergoing dialysis.

17. The method of claim 16, wherein the dialysis is selected from hemodialysis and peritoneal dialysis.

18. The method of claim 12, wherein the tablets are administered to provide 4 grams to 15 grams of ferric citrate to the subject per day.

19. The method of claim 12, wherein the tablets are administered to provide 2 grams to 12 grams of ferric citrate to the subject per day.

20. The method of claim 12, wherein the tablets are administered to provide 2 grams, 4 grams or 6 grams of ferric citrate to the subject per day.

21. The method of claim 12, wherein the tablets are administered to provide 1 gram of ferric citrate to the subject per day.

22. The method of claim 12, wherein the tablets each comprise 500 mg of ferric citrate.

23. A method of treating hyperphosphatemia, comprising: administering one or more tablets comprising ferric citrate and a pharmaceutically acceptable carrier to a subject, the tablets prepared from a form of ferric citrate having a BET active surface area of at least about 16 m.sup.2/g; wherein the tablets are administered to provide 3 grams to 6 grams of ferric citrate to the subject per day.

24. The method of claim 23, wherein the subject has chronic kidney disease.

25. The method of claim 24, wherein the chronic kidney disease is selected from early-stage chronic kidney disease and mid-stage chronic kidney disease.

26. The method of claim 24, wherein the chronic kidney disease is late-stage chronic kidney disease.

27. The method of claim 26, wherein the subject is undergoing dialysis.

28. The method of claim 27, wherein the dialysis is selected from hemodialysis and peritoneal dialysis.

29. The method of claim 23, wherein the tablets each comprise 500 mg of ferric citrate.

30. A method of treating metabolic acidosis, comprising: administering one or more tablets comprising ferric citrate and a pharmaceutically acceptable carrier to a subject, the tablets prepared from a form of ferric citrate having a BET active surface area of at least about 16 m.sup.2/g; wherein the tablets are administered to provide 3 grams to 6 grams of ferric citrate to the subject per day.

31. The method of claim 30, wherein the subject has chronic kidney disease.

32. The method of claim 31, wherein the chronic kidney disease is selected from early-stage chronic kidney disease and mid-stage chronic kidney disease.

33. The method of claim 31, wherein the chronic kidney disease is late-stage chronic kidney disease.

34. The method of claim 33, wherein the subject is undergoing dialysis.

35. The method of claim 34, wherein the dialysis is selected from hemodialysis and peritoneal dialysis.

36. The method of claim 30, wherein the tablets each comprise 500 mg of ferric citrate.

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