Claims for Patent: 7,855,217

Summary for Patent: 7,855,217

Title:	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione
Abstract:	Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione are disclosed. Compositions comprising the polymorphic forms, methods of making the polymorphic forms and methods of their use are also disclosed.
Inventor(s):	Jaworsky; Markian S. (Hopewell, NJ), Chen; Roger Shen-Chu (Edison, NJ), Muller; George W. (Bridgewater, NJ)
Assignee:	Celgene Corporation (Summit, NJ)
Application Number:	12/335,395
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,855,217
Patent Claims:	1. A solid form of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione comprising crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate, wherein the crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate is present at greater than about 80% by weight of the solid form. 2. A solid form of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione comprising crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate, wherein the crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate is present at greater than about 90% by weight of the solid form. 3. A solid form of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione comprising crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate, wherein the crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate is present at greater than about 95% by weight of the solid form. 4. A solid form of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione comprising crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate, wherein the crystalline 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione hemihydrate is present at greater than about 97% by weight of the solid form. 5. A pharmaceutical composition comprising a therapeutically effective amount of the solid form of claim 1, 2, 3, or 4, and a pharmaceutically acceptable excipient or carrier. 6. The pharmaceutical composition of claim 5, which is a single unit dosage form. 7. The pharmaceutical composition of claim 5, wherein the therapeutically effective amount is about 5 mg. 8. The pharmaceutical composition of claim 5, wherein the therapeutically effective amount is about 10 mg. 9. The pharmaceutical composition of claim 5, wherein the therapeutically effective amount is about 25 mg. 10. The pharmaceutical composition of claim 5, wherein the therapeutically effective amount is about 50 mg.