Claims for Patent: 7,893,101

Summary for Patent: 7,893,101

Title:	Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
Abstract:	Solid forms comprising (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions comprising the solid forms, methods of making the solid forms and methods of their use are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.
Inventor(s):	George W. Muller, Peter H. Schafer, Hon-Wah Man, Chuansheng Ge, Jean Xu
Assignee:	Amgen Inc
Application Number:	US12/079,615
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,893,101
Patent Claims:	1. A Form B crystal form of the compound of Formula (I): which is enantiomerically pure, and which has an X-ray powder diffraction pattern comprising peaks at about 10.1, 13.5, 20.7, and 26.9 degrees 2θ. 2. The crystal form of claim 1, which has an X-ray powder diffraction pattern further comprising peaks at about 12.4, 15.7, 18.1, and 24.7 degrees 2θ. 3. The crystal form of claim 2, which has an X-ray powder diffraction pattern further comprising peaks at about 16.3, 22.5, 26.2, and 29.1 degrees 2θ. 4. The crystal form of claim 1, which has an X-ray powder diffraction pattern matching the pattern depicted in FIG. 5. 5. The crystal form of claim 1, which has a differential scanning calorimetry plot comprising an endothermic event with an onset temperature of about 154° C. 6. The crystal form of claim 1, which has a differential scanning calorimetry plot matching the plot depicted in FIG. 6. 7. The crystal form of claim 1, which has a thermal gravimetric analysis plot comprising a mass loss of less than about 1% when heated from about 25° C. to about 140° C. 8. The crystal form of claim 7, wherein the mass loss is about 0.25%. 9. The crystal form of claim 1, which has a thermal gravimetric analysis plot matching the plot depicted in FIG. 7. 10. The crystal form of claim 1, which exhibits a mass increase of less than about 1% when subjected to an increase in relative humidity from about 0% to about 95% relative humidity. 11. The crystal form of claim 10, wherein the mass increase is about 0.6%. 12. The crystal form of claim 1, which has a moisture sorption isotherm plot matching the plot depicted in FIG. 8. 13. The crystal form of claim 1, which is stable upon exposure to about 40° C. and about 75% relative humidity for about 4 weeks. 14. The crystal form of any one of claims 1 and 2 to 13, which is substantially pure. 15. A solid pharmaceutical composition comprising the crystal form of any one of claims 1 and 2 to 13.