Claims for Patent: 9,610,265

Summary for Patent: 9,610,265

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 (Damastown Industrial Estate, Dublin, IE)
Application Number:	15/184,056
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,610,265
Patent Claims:	1. A method of treating pain in a human subject weighing at least 50 kg comprising: co-administering to the subject a therapeutically effective amount of a first pharmaceutical composition comprising about 500 mg to about 750 mg of acetaminophen and a therapeutically effective amount a second pharmaceutical composition comprising an opioid analgesic; wherein the first pharmaceutical composition is administered to the subject intravenously. 2. The method of claim 1 wherein the administration of the first pharmaceutical composition to the subject is repeated at least once every four hours for a twenty-four hour period. 3. The method of claim 1, wherein subject is administered less than 4 grams of acetaminophen over a twenty-four hour period. 4. The method of claim 3, wherein the first pharmaceutical composition is administered to the subject at least six times in a period of 24 hours. 5. The method of claim 3, wherein the first pharmaceutical composition is administered to the subject at least seven times in a period of 24 hours. 6. The method of claim 1, wherein the first pharmaceutical composition comprises about 600 mg to about 700 mg of acetaminophen. 7. The method of claim 1, wherein the first pharmaceutical composition comprises about 650 mg of acetaminophen. 8. The method of claim 1, wherein the opioid analgesic is selected from the group consisting of allylprodine, alphamethylfentanyl, alfentanil, bezitramide, buprenorphine, butorphanol, carfentanyl, codeine, dextropropoxyphene, dextromoramide, dezocine, diacetylmorphine, dihydrocodeine, dipapanone, dismorphine, dihydrocodeine, etorphine, fentanyl, hydrocodone, hydromorphone, ketobemidone, lefetamine, levorphanol, levo-alphacetylmethadol, levomethorphan, meptazinol, methadone, morphine, nalbuphine, nicomorphine, ohmefentanyl, opium, oripavine, oxycodone, oxymorphone, methadone, phenethylphenylacetoxypiperidine (PEPAP), pentazocine, pethidine, phenazocine, piritamide, prodine, propoxyphene napsylate, remifentanil, sufentanil, tilidine, thebaine, tramadol, and tapentadol. 9. The method of claim 8, wherein the opioid analgesic is selected from the group consisting of codeine, dihydrocodeine, hydrocodone, morphine, oxycodone, pentazocine, and tramadol. 10. The method of claim 8, wherein the opioid analgesic is morphine. 11. The method of claim 1, wherein the second pharmaceutical composition is administered to the subject orally, intravenously, recitally, or parenterally. 12. The method of claim 1, wherein the second pharmaceutical composition is administered as a single dose or in multiple doses. 13. The method of claim 1, wherein the first and second pharmaceutical compositions are administered simultaneously. 14. The method of claim 13, wherein the first and second pharmaceutical compositions are administered as a combined intravenous dosage form. 15. The method of claim 1, wherein the first and second pharmaceutical compositions are administered sequentially. 16. The method of claim 15, wherein the first pharmaceutical composition is administered prior to the second pharmaceutical composition or wherein the second pharmaceutical composition is administered prior to the first pharmaceutical composition. 17. The method of claim 15, wherein the timing between the administration of the first and second pharmaceutical compositions is from about 1 minute to less than about 12 hours. 18. The method of claim 15, wherein the timing between the administration of the first and second pharmaceutical compositions is from about 1 minute to less than about 6 hours. 19. The method of claim 15, wherein the timing between the administration of the first and second pharmaceutical compositions is from about 1 minute to less than about 3 hours. 20. The method of claim 15, wherein the timing between the administration of the first and second pharmaceutical compositions is from about 1 minute to less than about 1 hour.