CEDAZURIDINE; DECITABINE - Generic Drug Details

What are the generic drug sources for cedazuridine; decitabine and what is the scope of freedom to operate?

Cedazuridine; decitabine is the generic ingredient in one branded drug marketed by Taiho Oncology and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cedazuridine; decitabine has ninety-three patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for CEDAZURIDINE; DECITABINE

International Patents:	93
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	55
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CEDAZURIDINE; DECITABINE
DailyMed Link:	CEDAZURIDINE; DECITABINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CEDAZURIDINE; DECITABINE

Constraining patent/regulatory exclusivity:

8,268,800

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CEDAZURIDINE; DECITABINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Washington	PHASE2
Swedish Orphan Biovitrum	PHASE2
National Cancer Institute (NCI)	PHASE1

See all CEDAZURIDINE; DECITABINE clinical trials

Pharmacology for CEDAZURIDINE; DECITABINE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CEDAZURIDINE; DECITABINE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for CEDAZURIDINE; DECITABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	12,239,653
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	12,195,496		Y
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	11,963,971		Y

International Patents for CEDAZURIDINE; DECITABINE

Country	Patent Number	Title	Estimated Expiration
Philippines	12022552250	COMBINATION DECITABINE AND CEDAZURIDINE SOLID ORAL DOSAGE FORMS
Guatemala	201000088
Mexico	2010004109

Supplementary Protection Certificates for CEDAZURIDINE; DECITABINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	202340031	Slovenia		PRODUCT NAME: COMBINATION OF CEDAZURIDINE OR ITS PHARMACEUTICALLY ACCEPTEBLE SALT AND DECITABINE; NATIONAL AUTHORISATION NUMBER: EU/1/23/1756; DATE OF NATIONAL AUTHORISATION: 20230915; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2207786	23C1051	France		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786	CR 2023 00038	Denmark		PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918

Market Dynamics and Financial Trajectory for Cedazuridine/Decitabine

Last updated: February 13, 2026

Overview and Clinical Significance

Cedazuridine combined with decitabine forms an oral formulation approved for treating myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The combination was approved by the FDA in July 2020 under the brand name Inqovi. It offers a convenient alternative to intravenous decitabine, with potential impacts on patient adherence, healthcare costs, and hospital resource utilization.

Market Size and Growth Drivers

• Target Population: MDS and AML affect approximately 60,000-80,000 patients annually in the U.S. (source: CDC). The global MDS market was valued at $1.2 billion in 2020 and is projected to grow at a CAGR of 7% through 2027 (source: Mordor Intelligence). AML market surpassed $2.5 billion globally in 2021, expected to expand driven by aging populations and advances in treatment options.

• Treatment Paradigm Shift: The approval of oral formulations like cedazuridine/decitabine shifts treatment settings from hospital to outpatient care, potentially increasing adoption rates.

• Competitive Landscape: Currently, the market includes injectable decitabine, azacitidine (both hospital-administered), and emerging oral options, notably Vyxeos and oral azacitidine (CC-486). The convenience of oral therapy supports market penetration.

Market Penetration and Adoption

• Initial Adoption: Launched primarily in North America, with expanding presence in Europe and Asia. Early sales data indicate a slower uptake due to price, reimbursement challenges, and clinician familiarity.

• Pricing and Reimbursement: The wholesale acquisition cost (WAC) for Inqovi in the U.S. was approximately $10,068 per 28-day supply as of 2021. Reimbursement policies influence physician prescribing behaviors, especially for off-label or competing therapies.

• Physician Preference: Preference for traditional injectables persists among some clinicians due to familiarity or concerns about efficacy and safety data for oral forms.

Financial Trajectory and Revenue Projections

• Historical Sales: Novartis, which markets Inqovi, reported sales of approximately $40 million in 2021, representing early-stage market penetration.

• Forecasts: Analysts project a compound annual growth rate (CAGR) of 15-20% over the next five years, driven by increased adoption, expanded label indications, and geographic expansion. By 2027, revenues could approach $150 million globally if market uptake accelerates.

• Pricing Impact: Pricing strategy remains crucial; discounts or expanded indications, such as maintenance therapy in AML or MDS, could boost revenue.

Regulatory and Patent Landscape

• Patent Position: The core patent protecting cedazuridine/decitabine formulations is valid until 2035 in key markets, allowing exclusivity that supports revenue streams.

• Regulatory Environment: Ongoing trials aim to extend indications or develop similar compounds. Regulatory approvals in Europe, Japan, and China are pending or under review, influencing global revenue potential.

Challenges to Growth

• Market Competition: Oral azacitidine (CC-486) and emerging gene-targeted therapies threaten share.

• Reimbursement and Cost: High treatment costs and variable reimbursement procedures can hinder adoption, especially outside North America.

• Clinical Data: Limited long-term data compared to traditional formulations may impact clinician confidence.

Key Financial Metrics and Timeline

Year	Estimated Revenue (USD millions)	Growth Rate	Key Factors
2021	40	N/A	Early access, initial uptake
2023	70-90	17-25%	Broader market acceptance, expanding indications
2025	120-150	15-20%	Market penetration, new geographic regions

Conclusion

The market for cedazuridine/decitabine represents a niche with high growth potential, contingent on clinical validation, market acceptance, and reimbursement policies. Its financial trajectory hinges on expanding indications, geographic expansion, and competitive positioning.

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Key Takeaways

• The global MDS and AML markets are expanding, with oral formulations offering a convenient treatment alternative.
• Sales trajectory remains nascent, with projections indicating significant growth through 2027 driven by increased adoption.
• Reimbursement, pricing strategies, and clinical acceptance will significantly influence revenue performance.
• Competitive pressure from other oral hypomethylating agents and emerging therapies presents ongoing risks.
• Patent protection until 2035 offers a window for revenue generation and market exclusivity.

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FAQs

1. What factors influence the adoption of cedazuridine/decitabine?
Adoption depends on physician familiarity, clinical trial data supporting efficacy, reimbursement policies, and cost considerations. Pharmacoeconomic advantages over injectable forms favor uptake.

2. How does cedazuridine/decitabine compare to injectable decitabine in clinical outcomes?
Clinical trials show non-inferiority in efficacy and similar safety profiles. Long-term data is limited but ongoing studies aim to confirm sustained benefits.

3. What are the primary challenges in expanding the market?
Reimbursement hurdles, high treatment costs, clinician hesitance to switch from traditional formulations, and competition from other oral agents or emerging therapies.

4. What geographic regions are critical for growth?
North America leads, with Europe, Japan, and China as key targets for expansion due to rising incidence and evolving treatment protocols.

5. Are new formulations or combinations in development?
Yes, ongoing research explores combination therapies, maintenance strategies, and broader indications, potentially extending market opportunities post-2027.

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References

[1] Mordor Intelligence. "Myelodysplastic Syndromes Market – Growth, Trends, and Forecast (2021-2027)."
[2] CDC Reports. "Myelodysplastic Syndromes" (2022).
[3] Novartis. Inqovi Market Reports (2021).
[4] FDA. "Inqovi (cedazuridine and decitabine) approval announcement" (2020).