Claims for Patent: 10,092,542

Summary for Patent: 10,092,542

Title:	Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Abstract:	Stereomerically pure (+)-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoiso- indoline-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:	15/629,678
Patent Claims:	1. A method of treating or managing bone loss, which comprises administering to a patient a therapeutically effective amount of (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-4-acetylamino- isoindolin-1,3-dione: ##STR00002## or a pharmaceutically acceptable salt thereof. 2. The method of claim 1, wherein the bone loss is a primary bone loss. 3. The method of claim 2, wherein the primary bone loss is primary type 1 osteoporosis. 4. The method of claim 2, wherein the primary bone loss is primary type 2 osteoporosis. 5. The method of claim 1, wherein the bone loss is secondary to other underlying disorders. 6. The method of claim 5, wherein the underlying disorder is: rheumatoid arthritis; lupus; multiple sclerosis; ankylosing spondylitis; a digestive or gastrointestinal disorder; a digestive or gastrointestinal disorder; a hematologic disorder; stroke; Parkinson's disease; multiple sclerosis; spinal cord injury; a mental illness; bone cancer; breast cancer; or prostate cancer. 7. The method of claim 6, wherein the digestive or gastrointestinal disorder is celiac disease or inflammatory bowel disease. 8. The method of claim 6, wherein the digestive or gastrointestinal disorder is diabetes, hyperparathyroidism, hyperthyroidism, Cushing's syndrome, thyrotoxicosis, premature menopause, or unusual testosterone levels. 9. The method claim 6, wherein the hematologic disorder is leukemia, lymphoma, multiple myeloma, sickle cell disease, a blood and bone marrow disorder or thalassemia. 10. The method of claim 6, wherein the mental illness is depression or an eating disorder. 11. The method of claim 1, wherein the bone loss is caused by a therapeutic agent. 12. The method of claim 11, wherein the therapeutic agent is a corticosteroid, an antiepileptic, L-thyroxine, an aromatase inhibitor, methotrexate, depot-progesterone, a gonadotropin-releasing hormone agonist, a proton pump inhibitor, a thiazolidinedione, or lithium. 13. The method of claim 12, wherein the corticosteroid is prednisone or dexamethasone. 14. The method of claim 12, wherein the antiepileptic is a barbiturate or phenytoin. 15. The method of claim 1, wherein the bone loss is osteogenesis imperfecta, osteomalacia, rickets, ostesis fibrosa cystic or Paget's disease. 16. The method of claim 1, wherein the (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methanesulfonylethyl]-4-acetylamino- isoindolin-1,3-dione or a pharmaceutically acceptable salt, is administered in combination or alternation with a therapeutically effective amount of one or more additional active agents. 17. The method of claim 16, wherein the additional agent is a bisphosphonate, teriparatide, strontium renelate, raloxifene, denosumab, calcium, vitamin D, vitamin K or a combination thereof.

Details for Patent 10,092,542

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	PROLIA	denosumab	Injection	125320	06/01/2010		2022-03-20
Amgen, Inc.	XGEVA	denosumab	Injection	125320	11/18/2010		2022-03-20