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Last Updated: March 26, 2026

Claims for Patent: 12,053,482

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Summary for Patent: 12,053,482

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:	US18/138,473
Patent Claims:	1. A method for treating acute myelogenous leukemia, comprising orally administering once daily to a human subject in need thereof a pharmaceutical composition comprising from 180 mg to 360 mg of 5-azacytidine and at least one pharmaceutically acceptable excipient, wherein the composition is an immediate release film-coated tablet and releases at least 50% of the 5-azacytidine in the stomach following oral administration to the human subject. 2. The method of claim 1, wherein the film coat is the only coat of the tablet. 3. The method of claim 1, wherein the amount of 5-azacytidine is 300 mg. 4. The method of claim 1, wherein the amount of 5-azacytidine is 200 mg. 5. The method of claim 1, wherein the tablet does not comprise a methacrylic acid copolymer. 6. The method of claim 5, wherein the amount of 5-azacytidine is 300 mg. 7. The method of claim 1, wherein the pharmaceutical composition is orally administered for fourteen consecutive days. 8. The method of claim 7, wherein after the fourteen consecutive days of orally administering the pharmaceutical composition, the pharmaceutical composition is not administered for the next fourteen consecutive days. 9. The method of claim 1, wherein the pharmaceutical composition is orally administered for seven consecutive days. 10. The method of claim 8, wherein the amount of 5-azacytidine is 300 mg. 11. The method of claim 10, wherein the film coat is the only coat of the tablet. 12. The method of claim 9, wherein the amount of 5-azacytidine is 200 mg. 13. The method of claim 12, wherein the film coat is the only coat of the tablet. 14. The method of claim 1, wherein the composition releases at least 60% of the 5-azacytidine in the stomach following oral administration to the human subject. 15. The method of claim 1, wherein the composition releases at least 70% of the 5-azacytidine in the stomach following oral administration to the human subject. 16. The method of claim 2, wherein the amount of 5-azacytidine is 300 mg. 17. The method of claim 2, wherein the amount of 5-azacytidine is 200 mg. 18. The method of claim 2, wherein the pharmaceutical composition is orally administered for fourteen consecutive days. 19. The method of claim 18, wherein after the fourteen consecutive days of orally administering the pharmaceutical composition, the pharmaceutical composition is not administered for the next fourteen consecutive days. 20. The method of claim 2, wherein the pharmaceutical composition is orally administered for seven consecutive days. 21. The method of claim 5, wherein the amount of 5-azacytidine is 200 mg.

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