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Last Updated: October 22, 2019

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Claims for Patent: 10,258,637

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Summary for Patent: 10,258,637
Title:Pharmaceutical composition, methods for treating and uses thereof
Abstract: The present invention relates to certain SGLT-2 inhibitors for treating and/or preventing metabolic disorders, such as type 1 or type 2 diabetes mellitus or pre-diabetes, in patients with renal impairment or chronic kidney disease (CKD).
Inventor(s): Broedl; Uli Christian (Mainz am Rhein, DE), Macha; Sreeraj (Basking Ridge, NJ), von Eynatten; Maximilian (Wiesbaden, DE), Woerle; Hans-Juergen (Grandvaux, CH)
Assignee: Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:15/918,401
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,258,637
Patent Claims: 1. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.45 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg, wherein the glycemic control in said patient is improved, and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m.sup.2.

2. The method according to claim 1, wherein empagliflozin is administered in a total daily amount of 5 mg.

3. The method according to claim 1, wherein empagliflozin is administered in a total daily amount of 10 mg.

4. The method according to claim 1, wherein empagliflozin is administered in a total daily amount of 12.5 mg.

5. The method according to claim 1, wherein empagliflozin is administered in a total daily amount of 25 mg.

6. The method according to claim 1, further comprising administering metformin to the patient.

7. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising: a) assessing the renal function of a patient; b) administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.45 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg, wherein the glycemic control in said patient is improved; c) discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m.sup.2.

8. The method according to claim 7, wherein empagliflozin is administered in a total daily amount of 5 mg.

9. The method according to claim 7, wherein empagliflozin is administered in a total daily amount of 10 mg.

10. The method according to claim 7, wherein empagliflozin is administered in a total daily amount of 12.5 mg.

11. The method according to claim 7, wherein empagliflozin is administered in a total daily amount of 25 mg.

12. The method according to claim 7, further comprising administering metformin to the patient.

13. A method of treating type 2 diabetes mellitus in a patient comprising administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.45 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg, wherein the glycemic control in said patient is improved, and discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m.sup.2.

14. The method according to claim 13, wherein empagliflozin is administered in a total daily amount of 5 mg.

15. The method according to claim 13, wherein empagliflozin is administered in a total daily amount of 10 mg.

16. The method according to claim 13, wherein empagliflozin is administered in a total daily amount of 12.5 mg.

17. The method according to claim 13, wherein empagliflozin is administered in a total daily amount of 25 mg.

18. The method according to claim 13, further comprising administering metformin to the patient.

19. A method of treating type 2 diabetes mellitus comprising: a) assessing the renal function of a patient with type 2 diabetes mellitus; b) administering empagliflozin to the patient if the eGFR of the patient is .gtoreq.45 ml/min/1.73 m.sup.2 and <60 ml/min/1.73 m.sup.2, wherein empagliflozin is administered orally in a total daily amount of 5 mg, 10 mg, 12.5 mg or 25 mg, wherein the glycemic control in said patient is improved; c) discontinuing empagliflozin if the eGFR of the patient falls below 45 ml/min/1.73 m.sup.2.

20. The method according to claim 19, wherein empagliflozin is administered in a total daily amount of 5 mg.

21. The method according to claim 19, wherein empagliflozin is administered in a total daily amount of 10 mg.

22. The method according to claim 19, wherein empagliflozin is administered in a total daily amount of 12.5 mg.

23. The method according to claim 19, wherein empagliflozin is administered in a total daily amount of 25 mg.

24. The method according to claim 19, further comprising administering metformin to the patient.

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