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Last Updated: December 12, 2025

Claims for Patent: 11,833,166

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Summary for Patent: 11,833,166

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):	Uli Christian BROEDL, Sreeraj MACHA, Maximilian von EYNATTEN, Hans-Juergen Woerle
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US17/344,003
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,833,166
Patent Claims:	1. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising: a) assessing the renal function of the patient; and b) administering empagliflozin to the patient if the eGFR of the patient is ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and wherein the glycemic control in said patient is improved. 2. The method according to claim 1, wherein empagliflozin is administered in a total daily amount of 10 mg. 3. The method according to claim 1, wherein empagliflozin is administered in a total daily amount of 25 mg. 4. The method according to claim 1, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin. 5. The method according to claim 1, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin. 6. The method according to claim 1, further comprising administering metformin to the patient. 7. A method of treating type 2 diabetes mellitus comprising: a) assessing the renal function of a patient with type 2 diabetes mellitus; and b) administering empagliflozin to the patient if the eGFR of the patient is ≥45 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and wherein the glycemic control in said patient is improved. 8. The method according to claim 7, wherein empagliflozin is administered in a total daily amount of 10 mg. 9. The method according to claim 7, wherein empagliflozin is administered in a total daily amount of 25 mg. 10. The method according to claim 7, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin. 11. The method according to claim 7, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin. 12. The method according to claim 7, further comprising administering metformin to the patient. 13. A method for improving glycemic control in a patient with type 2 diabetes mellitus comprising: a) assessing the renal function of the patient; and b) administering empagliflozin to the patient if the eGFR of the patient is ≥30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and wherein the glycemic control in said patient is improved. 14. The method according to claim 13, wherein empagliflozin is administered in a total daily amount of 10 mg. 15. The method according to claim 13, wherein empagliflozin is administered in a total daily amount of 25 mg. 16. The method according to claim 13, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin. 17. The method according to claim 13, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin. 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; and b) administering empagliflozin to the patient if the eGFR of the patient is ≥30 ml/min/1.73 m2 and <60 ml/min/1.73 m2, wherein empagliflozin is administered orally in a total daily amount of 10 mg or 25 mg, and wherein the glycemic control in said patient is improved. 20. The method according to claim 19, wherein empagliflozin is administered in a total daily amount of 10 mg. 21. The method according to claim 19, wherein empagliflozin is administered in a total daily amount of 25 mg. 22. The method according to claim 19, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 10 mg of empagliflozin. 23. The method according to claim 19, wherein empagliflozin is administered orally once daily as a pharmaceutical composition comprising 25 mg of empagliflozin. 24. The method according to claim 19, further comprising administering metformin to the patient.

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