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Last Updated: March 26, 2026

Claims for Patent: 11,571,436

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Summary for Patent: 11,571,436

Title:	Oral formulations of cytidine analogs and methods of use thereof
Abstract:	The present disclosure provides pharmaceutical compositions comprising cytidine analogs for oral administration, wherein the compositions release the cytidine analog substantially in the stomach. Also provided are methods of treating diseases and disorders using the oral formulations provided herein.
Inventor(s):	Jeffrey B. Etter, Mei Lai, Jay Thomas Backstrom
Assignee:	Celgene Corp
Application Number:	US17/533,033
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,571,436
Patent Claims:	1. A pharmaceutical composition for oral administration comprising 180 mg to 360 mg of 5-azacytidine and at least one pharmaceutically acceptable excipient, wherein the composition is a non-enteric coated tablet, and wherein a therapeutically effective amount of 5-azacytidine is not absorbed through oral mucosa upon administration to a human subject. 2. The composition of claim 1, wherein the tablet is an immediate release tablet. 3. The composition of claim 2, wherein the amount of 5-azacytidine is 300 mg. 4. The composition of claim 2, wherein the amount of 5-azacytidine is 200 mg. 5. The composition of claim 1, wherein the tablet does not comprise a methacrylic acid copolymer. 6. The composition of claim 5, wherein the amount of 5-azacytidine is 300 mg. 7. The composition of claim 5, wherein the amount of 5-azacytidine is 200 mg. 8. The composition of claim 2, wherein the tablet does not comprise a methacrylic acid copolymer. 9. The composition of claim 8, wherein the amount of 5-azacytidine is 300 mg. 10. The composition of claim 8, wherein the amount of 5-azacytidine is 200 mg. 11. The composition of claim 1, wherein the tablet does not comprise triethyl citrate. 12. The composition of claim 2, wherein the tablet does not comprise triethyl citrate. 13. The composition of claim 3, wherein the tablet does not comprise triethyl citrate. 14. The composition of claim 4, wherein the tablet does not comprise triethyl citrate. 15. The composition of claim 1, wherein the tablet does not comprise polymethacrylate. 16. The composition of claim 2, wherein the tablet does not comprise polymethacrylate. 17. The composition of claim 3, wherein the tablet does not comprise polymethacrylate. 18. The composition of claim 4, wherein the tablet does not comprise polymethacrylate. 19. The composition of claim 1, wherein the tablet comprises a non-enteric coating comprising hydroxypropyl methyl cellulose. 20. The composition of claim 2, wherein the tablet comprises a non-enteric coating comprising hydroxypropyl methyl cellulose. 21. The composition of claim 3, wherein the tablet comprises a non-enteric coating comprising hydroxypropyl methyl cellulose. 22. The composition of claim 4, wherein the tablet comprises a non-enteric coating comprising hydroxypropyl methyl cellulose.

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