See the DrugPatentWatch profile for onureg
Yes, Onureg Is Oral Azacitidine
Onureg is the brand name for azacitidine formulated as an oral tablet, approved by the FDA for maintenance treatment of acute myeloid leukemia (AML) in adults in first complete remission after induction chemotherapy.[1]
How Does Onureg Differ from Injectable Azacitidine?
Traditional azacitidine (Vidaza or generics) is given by subcutaneous injection or IV infusion, typically daily for 7 days every 28-day cycle. Onureg uses the same active ingredient but in a delayed-release oral form taken once daily for 14 days every 28-day cycle, improving convenience for long-term maintenance.[1][2]
Who Makes Onureg and When Was It Approved?
Bristol Myers Squibb (BMS) developed and markets Onureg. The FDA approved it in July 2020 based on the phase 3 QUAZAR trial, which showed it extended overall survival versus placebo in AML maintenance.[1][3]
When Does Onureg's Patent Protection End?
Onureg's key composition-of-matter patent (U.S. Patent No. 9,566,270) for the oral azacitidine formulation expires in 2031, with potential pediatric exclusivity extending it to 2032. Challenges from generics are ongoing, but no approvals yet.[4]
What Do Patients Report About Taking Onureg?
Common side effects match injectable azacitidine: nausea (59%), diarrhea (50%), and fatigue (44%), but oral dosing reduces injection-site reactions. It's taken with food (except grapefruit) to boost absorption.[1][2]
[1]: FDA Label - Onureg (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214120s000lbl.pdf)
[2]: NCCN Guidelines - AML (https://www.nccn.org/guidelines)
[3]: New England Journal of Medicine - QUAZAR Trial (https://www.nejm.org/doi/full/10.1056/NEJMoa1914321)
[4]: DrugPatentWatch.com - Onureg Patents (https://www.drugpatentwatch.com/p/tradename/ONUREG)