Claims for Patent: 9,987,238

Summary for Patent: 9,987,238

Title:	Reduced dose intravenous acetaminophen
Abstract:	Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.
Inventor(s):	Royal; Mike Allan (San Diego, CA), Breitmeyer; James Bradley (Rancho Santa Fe, CA)
Assignee:	MALLINCKRODT IP (Dublin, IE)
Application Number:	15/436,285
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,987,238
Patent Claims:	1. A method of treating pain in a human subject, in need thereof, weighing at least 50 kg comprising: administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising about 500 mg to about 750 mg of acetaminophen; and repeating the administration at least once every four hours; wherein the pharmaceutical composition is administered to the subject intravenously; and wherein the therapeutic effect of the pharmaceutical composition is comparable to the standard of care treatment of 1000 mg of acetaminophen administered orally every 6 hours. 2. The method of claim 1, wherein subject is administered less than 4 grams of acetaminophen over a twenty-four hour period. 3. The method of claim 1, wherein the pharmaceutical composition is administered to the subject at least six times in a period of 24 hours. 4. The method of claim 1, wherein the pharmaceutical composition comprises about 600 mg to about 700 mg of acetaminophen. 5. The method of claim 1, wherein the pharmaceutical composition comprises about 650 mg of acetaminophen. 6. The method of claim 1, wherein the pharmaceutical composition further comprises at least one antioxidant. 7. The method of claim 6, wherein the antioxidant is cysteine hydrochloride monohydrate. 8. The method of claim 1, wherein the pharmaceutical composition further comprises a buffering agent. 9. The method of claim 5, wherein the buffering agent is selected from the group consisting of a pharmaceutically acceptable salt or acid of citrate, phosphate, acetate, glutamate, tartate, benzoate, lactate, histidine or other amino acids, gluconate, malate, succinate, formate, proprionate, carbonate, and any combinations thereof. 10. The method of claim 5, wherein the buffering agent is disodium phosphate dehydrate. 11. The method of claim 1, wherein the pharmaceutical composition has a pH between about 4 to about 8. 12. The method of claim 1, wherein the pharmaceutical composition has a pH between about 5 to about 6. 13. The method of claim 1, wherein the pharmaceutical composition has an osmolarity of between about 200 mOsm/L to about 400 mOms/L. 14. The method of claim 1, wherein the pharmaceutical composition further comprises an isotonicity agent. 15. The method of claim 14, wherein the isotonicity agent is selected from the group consisting of: dextrose, mannitol, and lactose. 16. The method of claim 14, wherein the isotonicity agent is mannitol. 17. The method of claim 1, wherein the pharmaceutical composition is a lyophilized powder. 18. The method of claim 17, wherein the lyophilized powder is reconstituted in solution prior to administration. 19. The method of claim 1, wherein the pharmaceutical composition is intravenously administered to the subject over about 5 minutes to about 30 minutes. 20. The method of claim 1, wherein the pharmaceutical composition is intravenously administered to the subject over about 15 minutes.