Claims for Patent: 9,724,330

Summary for Patent: 9,724,330

Title:	Methods of using (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Abstract:	Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, substantially free of its (-) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoin- doline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-.alpha. or the inhibition of PDE4.
Inventor(s):	Muller; George W. (Rancho Santa Fe, CA), Schafer; Peter H. (Belle Mead, NJ), Man; Hon-Wah (Princeton, NJ), Ge; Chuansheng (Belle Mead, NJ)
Assignee:	Celgene Corporation (Summit, NJ)
Application Number:	15/016,856
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,724,330
Patent Claims:	1. A method of treating an autoimmune disease, the method comprising administering to a patient having the autoimmune disease a therapeutically effective amount of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl) -2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione. 2. The method of claim 1 further comprising administering to the patient a therapeutically effective amount of an antihistamine, anti-inflammatory drug, non-steroid anti-inflammatory drug, or steroid. 3. The method of claim 1 wherein the patient is a mammal. 4. The method of claim 1 wherein the compound is administered parenterally, transdermally, mucosally, nasally, buccally, sublingually, or orally. 5. The method of claim 4 wherein the compound is administered orally. 6. The method of claim 5 wherein the compound is administered orally in a tablet or capsule form. 7. The method of claim 1 wherein the therapeutically effective amount is from about 1 mg to about 1000 mg per day. 8. The method of claim 7 wherein the therapeutically effective amount is from about 5 mg to about 500 mg per day. 9. The method of claim 8 wherein the therapeutically effective amount is from about 10 mg to about 200 mg per day. 10. The method of claim 2 wherein the non-steroid anti-inflammatory drug is selected from aspirin, salicylates, acetominophen, indomethacin, sulindac, etodolac, fenamates, tolmetin, ketorolac, diclofenac, ibuprofen, naproxen, fenoprofen, ketoprofen, flurbiprofen, oxaprozin, piroxicam, meloxicam and a pyrazolon derivative. 11. The method of claim 5, wherein the compound is administered twice daily in equally divided doses. 12. The method of claim 5, wherein the stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione comprises greater than about 90% by weight of (+) isomer based on the total weight percent of the compound. 13. The method of claim 5, wherein the stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione comprises greater than about 95% by weight of (+) isomer based on the total weight percent of the compound. 14. The method of claim 5, wherein the stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione comprises greater than about 97% by weight of (+) isomer based on the total weight percent of the compound. 15. The method of claim 6, wherein the capsule contains about 10 mg of the compound. 16. The method of claim 6, wherein the capsule contains about 20 mg of the compound. 17. The method of claim 6, wherein the capsule contains about 25 mg of the compound. 18. The method of claim 6, wherein the capsule contains about 50 mg of the compound. 19. The method of claim 6, wherein the tablet contains about 10 mg of the compound. 20. The method of claim 6, wherein the tablet contains about 20 mg of the compound. 21. The method of claim 6, wherein the tablet contains about 25 mg of the compound. 22. The method of claim 6, wherein the tablet contains about 50 mg of the compound. 23. The method of claim 1, wherein the stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione comprises about 98.7% by weight of (+) isomer based on the total weight percent of the compound. 24. The method of claim 23, wherein the compound is administered orally in a tablet form. 25. The method of claim 24, wherein the tablet is administered twice daily in equally divided doses. 26. The method of claim 25, wherein the tablet contains about 10 mg of the compound. 27. The method of claim 25, wherein the tablet contains about 20 mg of the compound. 28. The method of claim 24, wherein the tablet is administered in a single, once-a-day dose. 29. The method of claim 28, wherein the tablet contains about 100 mg of the compound. 30. The method of claim 24, wherein the therapeutically effective amount is from about 1 mg to about 1000 mg per day. 31. The method of claim 24, wherein the therapeutically effective amount is from about 5 mg to about 500 mg per day. 32. The method of claim 24, wherein the therapeutically effective amount is from about 10 mg to about 200 mg per day. 33. The method of claim 24, wherein the therapeutically effective amount is about 100 mg per day.