Claims for Patent: 9,198,863

Summary for Patent: 9,198,863

Title:	Controlled release hydrocodone formulations
Abstract:	A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.
Inventor(s):	Benjamin Oshlack, Hua-pin Huang, John K. Masselink, Alfred Tonelli
Assignee:	Purdue Pharma LP
Application Number:	US14/727,985
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,198,863
Patent Claims:	1. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a bitartrate salt of hydrocodone and a poly(alkylene oxide), the dosage form, after administration to a human subject, providing a C24/Cmax hydrocodone ratio of from about 0.55 to about 1.0, wherein the dosage form is a tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the bitartrate salt of hydrocodone is the only active agent in the dosage form. 2. The dosage form of claim 1, which provides a therapeutic effect for about 24 hours. 3. The dosage form of claim 1, wherein said administration is first administration. 4. The dosage form of claim 1, which comprises a 1,000,000 to 10/000,000 weight-average molecular weight poly(alkylene oxide). 5. The dosage form of claim 4, wherein the poly(alkylene oxide) is poly(ethylene oxide). 6. The dosage form of claim 5, wherein the poly(ethylene oxide) has a 7,000,000 average molecular weight. 7. The dosage form of claim 1, which comprises a poly(ethylene oxide) which has an average molecular weight of at least 400,000. 8. The dosage form of claim 1 which provides a C24/Cmax hydrocodone ratio of 0.55 to 0.85. 9. The dosage form of claim 8, which provides a C24/Cmax hydrocodone ratio of 0.6 to about 0.7. 10. The dosage form of claim 1, which provides a Tmax of hydrocodone at about 8 to about 14 hours after administration of the dosage form. 11. The dosage form of claim 1, which comprises an amount of the hydrocodone bitartrate salt which is equivalent to from about 5 mg to about 60 mg of hydrocodone. 12. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising a bitartrate salt of hydrocodone and a poly(alkylene oxide), the dosage form, after administration to human subjects, providing a mean C24/Cmax hydrocodone ratio of from about 0.55 to about 1.0, wherein the dosage form is a tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the bitartrate salt of hydrocodone is the only active agent in the dosage form. 13. The dosage form of claim 12, which provides a therapeutic effect for about 24 hours. 14. The dosage form of claim 12, wherein said administration is first administration. 15. The dosage form of claim 12, which comprises a 1,000,000 to 10/000,000 weight-average molecular weight poly(alkylene oxide). 16. The dosage form of claim 12, wherein the poly(alkylene oxide) is poly(ethylene oxide). 17. The dosage form of claim 16, wherein the poly(ethylene oxide) has a 7,000,000 average molecular weight. 18. The dosage form of claim 12, which provides a mean C24/Cmax hydrocodone ratio of 0.55 to 0.85. 19. The dosage form of claim 18, which provides a mean C24/Cmax hydrocodone ratio of 0.6 to about 0.7. 20. The dosage form of claim 12, which provides a mean Tmax of hydrocodone at about 8 to about 14 hours after administration of the dosage form. 21. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising hydrocodone or a pharmaceutically acceptable salt thereof and a poly(alkylene oxide), wherein the dosage form, after administration to a human subject, provides a W50 of hydrocodone of between 4 and 22 hours and a therapeutic effect for about 24 hours, the dosage form is a compressed tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the hydrocodone or pharmaceutically acceptable salt thereof is the only active agent in the dosage form. 22. The dosage form of claim 21, wherein said administration is first administration. 23. The dosage form of claim 21, wherein the dosage form provides a C24/Cmax hydrocodone ratio of from about 0.55 to about 1 after said administration. 24. The dosage form of claim 23, which provides C24/Cmax hydrocodone ratio of from 0.55 to about 0.85. 25. The dosage form of claim 24, which provides a C24/Cmax hydrocodone ratio of 0.55 to 0.75. 26. The dosage form of claim 25, which provides a C24/Cmax hydrocodone ratio of 0.6 to about 0.7. 27. The dosage form of claim 21, which provides a Tmax of hydrocodone at about 8 to about 14 hours after administration of the dosage form. 28. A solid oral controlled-release dosage form of hydrocodone, the dosage form comprising hydrocodone or a pharmaceutically acceptable salt thereof and a poly(alkylene oxide), wherein the dosage form, after administration to human subjects, provides a mean W50 of hydrocodone of between 4 and 22 hours and a therapeutic effect for about 24 hours, wherein the dosage form is a compressed tablet, the amount of hydrocodone in the dosage form is from about 0.5 mg to about 1250 mg, and the hydrocodone or pharmaceutically acceptable salt thereof is the only active agent in the dosage form. 29. The dosage form of claim 28, wherein said administration is first administration. 30. The dosage form of claim 23, which provides a mean C24/Cmax hydrocodone ratio of from 0.55 to about 0.85, and a mean a Tmax of hydrocodone at about 8 to about 14 hours after administration of the dosage form.