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 eighty-eight patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for cedazuridine; decitabine

International Patents:	88
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

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	9,567,363			Y
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	11,963,971		Y
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	12,195,496		Y

International Patents for cedazuridine; decitabine

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112781
Canada	2702274	CERTAINS COMPOSES, COMPOSITIONS ET PROCEDES (2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
World Intellectual Property Organization (WIPO)	2009052287
Serbia	52323	2'-FLUORO-2'-DEOKSITETRAHIDROURIDINI KAO INHIBITORI CITIDIN DEAMINAZE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)

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	PA2023538	Lithuania		PRODUCT NAME: CEDAZURIDINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786	PA2023539	Lithuania		PRODUCT NAME: KOMPOZICIJA, APIMANTI: CEDAZURIDINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; IR DECITABINAS; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786	2023C/551	Belgium		PRODUCT NAME: UNE COMPOSITION COMPRENANT : DE LA CEDAZURIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ; ET LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918

Market Dynamics and Financial Trajectory for CEDAZURIDINE and DECITABINE

Last updated: July 28, 2025

Introduction

The landscape of hematological malignancies and other cancers has significantly evolved with the advent of hypomethylating agents like Cedazuridine and Decitabine. These agents have shifted treatment paradigms, especially for conditions such as myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Understanding the market dynamics and financial trajectory of these drugs is crucial for stakeholders—including pharmaceutical companies, investors, and healthcare providers—seeking to optimize decision-making in this competitive space.

Overview of Cedazuridine and Decitabine

Decitabine, a nucleoside metabolic inhibitor approved by the FDA in 2006, functions as a hypomethylating agent. Its mechanism involves incorporation into DNA, inhibiting DNA methyltransferase, thereby reversing aberrant methylation patterns in malignant cells, leading to cell differentiation and apoptosis (1). Traditional administration of decitabine involves intravenous infusion, which imposes logistical and compliance challenges.

Cedazuridine (development code: ASTX727) is a novel oral prodrug designed to enhance the bioavailability of decitabine by inhibiting cytidine deaminase in the gastrointestinal tract and liver. Its co-administration with decitabine allows oral dosing, improving patient convenience. In 2020, the FDA approved Decitabine and Cedazuridine as a fixed-dose combination for MDS patients, representing a milestone in oral targeted therapy (2).

Market Dynamics

1. Competitive Landscape

The market for hypomethylating agents is primarily dominated by Azacitidine and Decitabine, both of which are established intravenously administered therapies. The introduction of Cedazuridine with oral decitabine introduces a disruptive alternative, offering:

• Enhanced patient compliance due to oral administration
• Reduced healthcare costs associated with infusion-related infrastructure
• Potential for outpatient therapy, decreasing hospitalization durations

However, the competitive impact hinges on clinical efficacy, safety, and pricing strategies. Several pharmaceutical players and biotech firms are exploring or developing similar oral formulations, intensifying competition.

2. Market Penetration Drivers

Key factors influencing the adoption of Cedazuridine/Decitabine include:

• Patient Preference: The convenience of oral therapy aligns with patient-centric care models.

• Healthcare System Incentives: Cost-effective outpatient options appeal to payers and providers aiming to reduce hospitalization.

• Regulatory Approvals: Broader approvals across different geographies can accelerate market penetration.

• Clinical Data: Robust trial results demonstrating non-inferiority or superiority to IV forms bolster confidence among prescribers.

• Physician and Patient Education: Effective education campaigns are crucial for adoption, particularly when shifting from established IV therapies.

3. Market Barriers

Barriers include:

• Long-term safety and efficacy data: As the oral formulation is relatively new, some practitioners may exercise caution.

• Pricing and reimbursement challenges: Negotiations with insurers and health authorities could impact profitability.

• Market inertia: Established treatment protocols for AML and MDS favor existing IV therapies, potentially delaying uptake.

4. Regulatory Environment

Regulatory approvals in key markets influence market prospects. The FDA approval (2020) and subsequent EMA approval can catalyze sustained growth. Upcoming indications in other hematologic conditions or solid tumors could expand the market.

5. Strategic Collaborations and Licensing

Partnerships between biotech firms (e.g., Astex Pharmaceuticals, now part of Otello Corporation) and global pharmaceutical companies can accelerate commercialization and market reach. Licensing agreements can also subsidize research costs, enhancing financial prospects.

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Financial Trajectory

1. Revenue Projections

Initial revenues for Cedazuridine/Decitabine are expected to come from countries with established hematology markets, notably the U.S., Europe, and Japan. The following factors influence revenue forecasts:

• Market entry timing
• Market share capture rate
• Pricing strategy relative to IV applications
• Patient volume growth

Analysts estimate that, in the first five years post-launch, the combined product could generate annual revenues in the hundreds of millions USD, with potential to exceed $1 billion as indications broaden and adoption increases (3).

2. R&D Investment and Cost Structures

Development costs for Cedazuridine, including clinical trials and regulatory submissions, have been substantial but are amortized within the broader company R&D budgets. Post-approval, manufacturing costs for the oral formulation tend to decline with scale, improving margins.

3. Market Penetration and Adoption Rates

Early adoption tends to be slow due to conservatism among physicians, but with positive trial data and patient demand, market share could grow rapidly. A mature phase might see Cedazuridine/Decitabine commanding a significant share of the hypomethylating agent market.

4. Pricing Strategies

Pricing in the oral formulation must balance profitability with competitive positioning. Given the potential to reduce healthcare resource utilization, payers may favor coverage, enabling favorable reimbursement terms. Price premiums over IV forms may be justified based on convenience and reduced administration costs.

5. Impact of Biosimilar and Generic Competition

As patents expire, biosimilars and generics could pressurize pricing. Currently, patent protections provide a competitive moat, but future patent cliffs could erode margins unless innovation continues.

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Market Opportunities and Risks

Opportunities

• Expanding indications to cover other hematological malignancies or solid tumors.
• Enhanced compliance could improve therapeutic outcomes, creating repeat business.
• Global expansion into emerging markets with growing healthcare infrastructure.
• Digital health integration for adherence tracking and remote monitoring.

Risks

• Delayed market access due to regulatory hurdles.
• Clinical setbacks impacting perceived efficacy or safety.
• Pricing disputes could limit profitability.
• Competitive innovations disrupting market share.

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Key Takeaways

• Cedazuridine combined with Decitabine offers a promising oral alternative to traditional IV hypomethylating agents, addressing key preferences in patient and healthcare system dynamics.
• Market success depends on robust clinical data, regulatory approvals across geographies, and effective commercialization strategies.
• Early adoption is shaped by payer reimbursement policies, physician confidence, and patient demand, with significant upside potential if expanding indications materialize.
• Financially, this combination is poised for growth, with revenues expected to rise incrementally as market penetration deepens and indications expand.
• Strategic partnerships, patent protections, and proactive pricing strategies will be decisive in maintaining competitive advantage and achieving financial targets.

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Conclusion

The pharmaceutical landscape for hypomethylating agents is on the cusp of transformation driven by Cedazuridine/Decitabine. As oral formulations gain traction, their market dynamism will intensify, requiring continuous adaptation by stakeholders. The financial trajectory indicates strong growth potential, contingent on successful market penetration, regulatory navigation, and innovation sustainability.

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FAQs

Q1: How does Cedazuridine improve decitabine therapy?
A: Cedazuridine inhibits cytidine deaminase, an enzyme that degrades decitabine, enabling oral bioavailability and eliminating the need for intravenous infusion.

Q2: What are the main advantages of oral decitabine over IV forms?
A: Oral decitabine offers improved patient convenience, reduces hospital visits, lowers healthcare costs, and facilitates outpatient management.

Q3: What factors influence the adoption of Cedazuridine/Decitabine in the market?
A: Clinical efficacy, safety profile, regulatory approvals, reimbursement policies, physician and patient acceptance, and competitive pricing are critical determinants.

Q4: Are there any significant hurdles to the widespread adoption of Cedazuridine?
A: Yes; these include long-term safety concerns, physician familiarity with existing therapies, reimbursement challenges, and potential competition from biosimilars.

Q5: What future opportunities exist for Cedazuridine in oncology treatment?
A: Expansion into other cancers, broader indications such as solid tumors, and integration into combination regimens present promising avenues for growth.

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References

1. National Center for Biotechnology Information. Decitabine. PubChem Compound Summary.
2. U.S. Food & Drug Administration. FDA approves first oral treatment for myelodysplastic syndromes. 2020.
3. Market Insights Reports. Hypomethylating Agents Market Forecast 2022-2027.