Prescription medicine
Cedazuridine and decitabine Brand names: Inqovi
Cedazuridine and decitabine (Inqovi) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cedazuridine and decitabine FDA label on DailyMed (effective May 25, 2026, Taiho Pharmaceutical Co., Ltd.); the NDA 212576 record on Drugs@FDA; every cedazuridine and decitabine label on DailyMed.
Highlights of the record
FDA label of May 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess
Forms and strengths
- 100 mg / 35 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 7, 2020 Inqovi, Taiho Oncology; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 10, 2042 Inqovi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 875 through July 30, 2026
What is cedazuridine and decitabine used for?
From the label: indications and usageINQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. […]
Conditions named in the indications of cedazuridine and decitabine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (INQOVI), Taiho Pharmaceutical Co., Ltd., effective May 25, 2026 (SPL set 91a0f80b-f865-4d06-a40d-4d148d99ee71), via openFDA; the full label on DailyMed
Is there a generic for cedazuridine and decitabine (Inqovi)?
No generic cedazuridine and decitabine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Inqovi tablets: the compound patent runs to February 12, 2034, and the last listed entry to December 10, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cedazuridine and decitabine label say about other medicines?
The cedazuridine and decitabine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Venetoclax | warnings and precautions | INQOVI in Combination with Venetoclax for AML In patients with AML, INQOVI can cause severe myelosuppression, including fatal adverse reactions, when given in combination with venetoclax. |
Source: FDA drug label (INQOVI), Taiho Pharmaceutical Co., Ltd., effective May 25, 2026 (SPL set 91a0f80b-f865-4d06-a40d-4d148d99ee71), via openFDA; the full label on DailyMed
What do FAERS reports show for cedazuridine and decitabine?
The FDA Adverse Event Reporting System holds 875 reports that list cedazuridine and decitabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 176 are coded as a death and 340 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cedazuridine and decitabine?
37 other medicines are given the same way (oral) and in the same FDA class as cedazuridine and decitabine or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Mercaptopurine | Leukemia, lymphoma and myeloma | 2 labelers | $1.07 per tablet 50 mg tablet | No current entry |
| Azacitidine | Leukemia, lymphoma and myeloma | none listed | n/a | In shortage |
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as cedazuridine and decitabine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cedazuridine and decitabine
- 37 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Cedazuridine and decitabine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other