INQOVI Drug Patent Profile

Which patents cover Inqovi, and when can generic versions of Inqovi launch?

Inqovi is a drug marketed by Taiho Oncology and is included in one NDA. There are six patents protecting this drug.

This drug has eighty-nine patent family members in forty-one countries.

The generic ingredient in INQOVI is cedazuridine; decitabine. One supplier is listed for this compound. Additional details are available on the cedazuridine; decitabine profile page.

DrugPatentWatch^® Generic Entry Outlook for Inqovi

Inqovi was eligible for patent challenges on July 7, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 22, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INQOVI

International Patents:	89
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	28
Drug Prices:	Drug price information for INQOVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INQOVI
What excipients (inactive ingredients) are in INQOVI?	INQOVI excipients list
DailyMed Link:	INQOVI at DailyMed

See drug prices for INQOVI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INQOVI

Constraining patent/regulatory exclusivity:

8,268,800

NDA:

212576

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 INQOVI

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

Sponsor	Phase
Break Through Cancer	EARLY_PHASE1
Astex Pharmaceuticals, Inc.	EARLY_PHASE1
Lachelle D. Weeks, MD, PhD	EARLY_PHASE1

See all INQOVI clinical trials

Pharmacology for INQOVI

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

US Patents and Regulatory Information for INQOVI

INQOVI is protected by eleven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,268,800.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	8,618,075
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	8,268,800			Y
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

International Patents for INQOVI

When does loss-of-exclusivity occur for INQOVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

Netherlands

New Zealand

Nicaragua

Norway

Poland

Portugal

Saudi Arabia

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INQOVI around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	12022552250
Mexico	2022010214
South Africa	201002178	2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Canada	3163122
European Patent Office	2447272
Lithuania	4069254

Supplementary Protection Certificates for INQOVI

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	C20230040	Finland
2207786	C20230039	Finland
2207786	23C1052	France		PRODUCT NAME: UNE COMPOSITION COMPRENANT: LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, ET LA DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786	2023C/550	Belgium		PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
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 INQOVI

Last updated: July 27, 2025

Introduction

INQOVI (decitabine and cedazuridine) is an oral hypomethylating agent approved by the U.S. Food and Drug Administration (FDA) in 2020 for treating myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) in adult patients. Combining decitabine with cedazuridine, a potent cytidine deaminase inhibitor, offers a novel oral alternative to traditional intravenous (IV) hypomethylating agents. This article analyzes the evolving market landscape and projections for INQOVI's financial performance, considering key drivers, competitive influences, and emerging opportunities.

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Market Landscape and Key Drivers

Growing Demand for Oral Chemotherapy Agents

The shift from hospital-based IV treatments towards oral therapies is a major industry trend. Patients favor oral medications for convenience, reduced hospital visits, and potentially improved quality of life, particularly among elderly populations who constitute the primary demographic for MDS and CMML treatments (source: [1]). INQOVI’s oral formulation aligns with this patient preference, likely augmenting its adoption.

Rising Incidence of MDS and CMML

The prevalence of MDS, primarily affecting adults over 60, continues to rise globally. According to the American Cancer Society, approximately 10,000-20,000 new cases of MDS are diagnosed annually in the U.S. alone, with incidences expected to increase due to aging populations ([2]). CMML, a less common but aggressive form, also contributes to the market's potential. The increasing patient pool underpins steady demand for hypomethylating agents.

Regulatory and Reimbursement Environment

Regulatory approvals and reimbursement policies significantly influence INQOVI’s market penetration. As an FDA-approved product with payers acknowledging its convenience and efficacy, INQOVI benefits from a favorable reimbursement landscape. Additionally, ongoing discussions on healthcare cost containment favor oral over IV therapies due to lower administration costs.

Competitive Landscape

INQOVI faces competition from traditional IV hypomethylating agents, including azacitidine (Vidaza) and decitabine (administered IV or subcutaneously). However, the introduction of an oral formulation provides a competitive advantage—especially if efficacy, safety, and cost are comparable or superior ([3]). Some competitors are developing other oral hypomethylating agents, but INQOVI’s accelerated approval and clinical validation position it favorably.

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Financial Trajectory and Market Penetration

Initial Sales Performance and Growth Trajectory

Since its launch, INQOVI has experienced gradual market penetration. Initial sales were moderate, constrained by factors such as physician familiarity with existing IV therapies and coverage limitations. However, sales are expected to accelerate as prescribers gain confidence, with early adoption driven by patient convenience and clinical data supporting efficacy comparable to IV decitabine.

Pricing Strategy and Market Share

Pricing for INQOVI is calibrated to remain competitive with existing IV regimens. Given the benefits of oral administration, insurers may offer favorable reimbursement, boosting adoption. Market share growth depends on clinical outcomes, physician perception, and patient adherence, which studies suggest are positively influenced by oral delivery routes ([4]).

Potential Revenue Streams

Long-term revenue projections hinge on treatment duration, patient adherence, and expansion into related indications such as acute myeloid leukemia (AML) maintenance therapy. The current market estimates project INQOVI could generate hundreds of millions of dollars annually within 3-5 years, assuming successful market penetration and evolving treatment guidelines.

Expansion Opportunities

Emerging clinical trials explore INQOVI's utility in other hematologic malignancies and in combination therapies—pivotal for revenue diversification. Moreover, expanded approvals and inclusion in treatment guidelines could further elevate its market position.

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Market Challenges and Risks

Competition and Clinical Alternatives

Existing IV formulations remain entrenched in clinical practice. Any failure of INQOVI to demonstrate clear advantages may hinder rapid market share acquisition. Competitors' pipeline innovations and biosimilar developments pose additional threats.

Patient Compliance and Adherence

While oral therapies offer convenience, adherence challenges persist, particularly among elderly patients with polypharmacy. Ensuring consistent medication intake is crucial for efficacy and may affect revenue forecasts.

Pricing and Reimbursement Uncertainties

Reimbursement policies may evolve, impacting profitability. Payers may negotiate favorable formulary placements or introduce Tiered pricing, influencing patient access.

Regulatory and Clinical Risks

Post-marketing surveillance and additional clinical data could reveal safety or efficacy concerns, affecting market confidence and sales.

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Future Outlook and Strategic Considerations

Market Expansion and Indication Growth

Further clinical development could extend INQOVI’s indications into AML or earlier lines of therapy, broadening its market. Promotional strategies emphasizing patient convenience and cost-effectiveness will be vital.

Partnerships and Collaborations

Partnering with healthcare providers, payers, and patient advocacy groups may enhance market uptake. Investment in patient adherence programs could optimize outcomes and revenue.

Competitive Positioning

Continued clinical evidence demonstrating superior efficacy and safety, alongside favorable cost profiles, will cement INQOVI’s place in the evolving therapy landscape.

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Conclusion

INQOVI is positioned to capitalize on evolving treatment paradigms favoring oral oncology drugs. Its market trajectory hinges on clinical validation, reimbursement pathways, and effective commercialization strategies. While challenges exist, the drug’s unique oral formulation and expanding hematologic indications suggest a promising growth trajectory with significant revenue potential.

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Key Takeaways

• The shift toward oral chemotherapy offers a strategic advantage for INQOVI, aligning with patient preferences and healthcare cost containment efforts.
• Growing incidence rates of MDS and CMML underpin sustained demand, supported by an expanding patient demographic.
• Success relies on physician adoption, favorable reimbursement, and competitive positioning against traditional IV therapies.
• Long-term revenue potential depends on indication expansion, ongoing clinical evidence, and effective market access strategies.
• Risks include competition, adherence issues, and regulatory changes, necessitating vigilant market monitoring and adaptive tactics.

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FAQs

1. What distinguishes INQOVI from traditional hypomethylating agents?
INQOVI offers an oral formulation of decitabine combined with cedazuridine, enabling outpatient treatment without infusions. This enhances patient convenience while maintaining comparable efficacy to IV decitabine.

2. How does reimbursement influence INQOVI’s market penetration?
Favorable reimbursement facilitates easier patient access and encourages physician prescribing, directly impacting sales growth and revenue trajectory.

3. What are the main hurdles for INQOVI's widespread adoption?
Key barriers include physician familiarity with existing IV options, adherence challenges among elderly patients, and potential payer restrictions.

4. Are additional indications for INQOVI anticipated?
Yes, ongoing clinical trials are exploring its use in AML and as maintenance therapy, which could considerably expand its market scope.

5. How does INQOVI’s market outlook compare to competitors?
Its unique oral delivery provides a competitive edge, especially if clinical outcomes remain comparable or superior. Rapid adoption depends on continued efficacy, safety data, and reimbursement support.

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Sources:

[1] American Cancer Society. "Myelodysplastic Syndromes (MDS)." 2023.
[2] American Cancer Society. "Key Statistics for Myelodysplastic Syndromes." 2023.
[3] Wang, L., et al. "Oral Hypomethylating Agents in Hematology." Hematology Reports, 2022.
[4] Smith, J., et al. "Patient Preferences for Oral versus Intravenous Chemotherapy." Journal of Oncology Practice, 2021.