Claims for Patent: 12,194,025

Summary for Patent: 12,194,025

Title:	Pharmaceutical composition for oral administration of edaravone and method of administering same
Abstract:	A method of treating an oxidative stress disease includes orally or intragastrically administering, to a subject in need thereof, a pharmaceutical composition including edaravone with a time interval from a consumption of a meal by the subject in need thereof to an administration of the pharmaceutical composition to the subject in need thereof. The time interval is 8 hours or longer after the consumption of a high-fat meal, the time interval is 4 hours or longer after the consumption of a standard meal, or the time interval is 2 hours or longer after the consumption of a light meal.
Inventor(s):	Hidetoshi Shimizu, Yoshinobu NAKAMARU, Yukiko NISHIMURA
Assignee:	Mitsubishi Tanabe Pharma Corp
Application Number:	US18/311,415
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,194,025
Patent Claims:	1. A method of treating amyotrophic lateral sclerosis, comprising: orally or intragastrically administering, to a subject in need thereof, a liquid pharmaceutical composition comprising edaravone with a first time interval from a consumption of a meal by the subject in need thereof to an administration of the liquid pharmaceutical composition to the subject in need thereof, wherein the first time interval for the consumption of a high-fat meal in a range of 800 to 1000 calories with 50% fat is 8 hours before the administration of the liquid pharmaceutical composition to the subject in need thereof, the first time interval for the consumption of a low-fat meal in a range of 400 to 500 calories with 25% fat is 4 hours before the administration of the liquid pharmaceutical composition to the subject in need thereof, or the first time interval for the consumption of a caloric supplement of 250 calories is 2 hours before the administration of the liquid pharmaceutical composition to the subject in need thereof such that a decrease in Cmax is less than 20% with respect to Cmax in a same time range in fasting for 10 hours or longer and/or that a decrease in AUC is less than 10% with respect to AUC in a same time range in fasting for 10 hours or longer. 2. The method of claim 1, wherein a second time interval from the administration of the liquid pharmaceutical composition to a consumption of a next meal by the subject in need thereof is 30 minutes or longer. 3. The method of claim 1, wherein a second time interval from the administration of the liquid pharmaceutical composition to a consumption of a next meal by the subject in need thereof is 1 hour or longer. 4. The method of claim 1, wherein the administration of the liquid pharmaceutical composition is oral administration. 5. The method of claim 1, wherein the administration of the liquid pharmaceutical composition is intragastric administration. 6. The method of claim 5, wherein the intragastric administration is administration via a tube. 7. The method of claim 6, wherein the tube is one of a percutaneous endoscopic gastrostomy catheter and a nasopharyngeal gastric catheter. 8. The method of claim 1, wherein the liquid pharmaceutical composition is administered to the subject in need thereof intermittently or daily such that the first time interval is a time interval during an administration period of an intermittent or daily administration. 9. The method of claim 1, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a dose of edaravone per administration is in a range of 90 to 120 mg. 10. The method of claim 1, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a frequency of a daily administration is once and that a dose of edaravone per administration is 105 mg. 11. The method of claim 1, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a frequency of a daily administration is once and that a dose of edaravone per administration is 100 mg. 12. The method of claim 2, wherein the administration of the liquid pharmaceutical composition is oral administration. 13. The method of claim 2, wherein the administration of the liquid pharmaceutical composition is intragastric administration. 14. The method of claim 13, wherein the intragastric administration is administration via a tube. 15. The method of claim 14, wherein the tube is one of a percutaneous endoscopic gastrostomy catheter and a nasopharyngeal gastric catheter. 16. The method of claim 2, wherein the liquid pharmaceutical composition is administered to the subject in need thereof intermittently or daily such that the first time interval is a time interval during an administration period of an intermittent or daily administration. 17. The method of claim 2, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a dose of edaravone per administration is in a range of 90 to 120 mg. 18. The method of claim 2, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a frequency of a daily administration is once and that a dose of edaravone per administration is 105 mg. 19. The method of claim 2, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a frequency of a daily administration is once and that a dose of edaravone per administration is 100 mg. 20. The method of claim 3, wherein the administration of the liquid pharmaceutical composition is oral administration. 21. The method of claim 3, wherein the administration of the liquid pharmaceutical composition is intragastric administration. 22. The method of claim 21, wherein the intragastric administration is administration via a tube. 23. The method of claim 22, wherein the tube is one of a percutaneous endoscopic gastrostomy catheter and a nasopharyngeal gastric catheter. 24. The method of claim 3, wherein the liquid pharmaceutical composition is administered to the subject in need thereof intermittently or daily such that the first time interval is a time interval during an administration period of an intermittent or daily administration. 25. The method of claim 3, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a dose of edaravone per administration is in a range of 90 to 120 mg. 26. The method of claim 3, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a frequency of a daily administration is once and that a dose of edaravone per administration is 105 mg. 27. The method of claim 3, wherein the liquid pharmaceutical composition is administered to the subject in need thereof such that a frequency of a daily administration is once and that a dose of edaravone per administration is 100 mg.