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 seven patents protecting this drug.

The generic ingredient in INQOVI is cedazuridine; decitabine. There is one drug master file entry for this compound. 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 February 24, 2041. 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

US Patents:	7
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

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 twelve US patents and two FDA Regulatory Exclusivities.

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
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes				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
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes				Y
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes			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

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Philippines

Poland

Portugal

Saudi Arabia

Slovenia

South Korea

Spain

Taiwan

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
Australia	2021227888
Brazil	112022013264
Canada	3163122
China	115151261
Denmark	4069254
European Patent Office	4069254	FORMES POSOLOGIQUES ORALES SOLIDES COMPRENANT DE LA DECITABINE ET DE LA CÉDAZURIDINE (SOLID ORAL DOSAGE FORMS COMPRISING DECITABINE AND CEDAZURIDINE)
European Patent Office	4470622	FORMES POSOLOGIQUES ORALES SOLIDES COMBINEES DECITABINE ET DE CEDAZURIDINE (COMBINATION DECITABINE AND CEDAZURIDINE SOLID ORAL DOSAGE FORMS)

Supplementary Protection Certificates for INQOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	301256	Netherlands		PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786	301257	Netherlands		PRODUCT NAME: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786	CA 2023 00037	Denmark		PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918
2207786	CA 2023 00038	Denmark		PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918
2207786	LUC00326	Luxembourg		PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913
2207786	LUC00327	Luxembourg		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786	CR 2023 00037	Denmark		PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918

INQOVI Market Dynamics, Financial Trajectory, Patent Protection, and Generic Risk

Last updated: September 26, 2026

INQOVI, the oral decitabine and cedazuridine combination marketed by Taiho Oncology, has a differentiated position in myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Its commercial value comes from replacing five consecutive days of intravenous decitabine with a five-day oral regimen. The main market constraints are the small hematology-oncology population, competition from intravenous hypomethylating agents, treatment toxicity, reimbursement, and the absence of publicly reported standalone product revenue.

The product received FDA approval in July 2020 and has orphan-drug exclusivity through July 2027. Its commercial protection extends beyond regulatory exclusivity through Orange Book-listed patent rights that are expected to reach at least the mid-2030s, subject to patent-term adjustments, pediatric extensions, litigation and settlement outcomes. Generic entry before 2027 is unlikely without a successful Paragraph IV challenge or an authorized generic strategy.

What is INQOVI and where does it compete?

INQOVI is a fixed-dose oral tablet containing 35 mg of decitabine and 100 mg of cedazuridine. It is administered once daily on Days 1 through 5 of a 28-day cycle.

The FDA approved INQOVI for adults with:

• Myelodysplastic syndromes, including previously untreated and previously treated disease
• Intermediate-1, intermediate-2 and high-risk disease under the International Prognostic Scoring System
• Chronic myelomonocytic leukemia

The product competes mainly with intravenous decitabine, including DACOGEN, and intravenous azacitidine, marketed as VIDAZA or supplied through generic channels. It is used in patients who are not candidates for, or do not immediately proceed to, allogeneic hematopoietic stem-cell transplantation.

Product	Active ingredient	Administration	Primary commercial role
INQOVI	Decitabine/cedazuridine	Oral, five days per cycle	Convenience-oriented alternative to IV decitabine
DACOGEN	Decitabine	Intravenous	Reference decitabine therapy
VIDAZA and generic azacitidine	Azacitidine	Subcutaneous or intravenous	Larger hypomethylating-agent competitor
Oral azacitidine, ONUREG	Azacitidine	Oral maintenance therapy	Different setting, mainly post-remission AML maintenance

INQOVI is not a direct substitute for ONUREG in all patients. ONUREG is approved for continued treatment of adults with acute myeloid leukemia in first remission after intensive induction chemotherapy who cannot complete curative therapy. INQOVI is positioned primarily in MDS and CMML.

How large is the INQOVI market opportunity?

The addressable market is concentrated but clinically durable. MDS incidence rises sharply with age, and many patients require repeated cycles of hypomethylating-agent therapy. Treatment can continue for months or years when the therapy controls symptoms or delays progression.

The commercial opportunity depends on four variables:

1. The number of newly diagnosed and relapsed MDS and CMML patients.
2. The share of patients receiving decitabine or azacitidine.
3. The percentage willing and able to switch from infusion-based treatment to oral therapy.
4. Persistence on treatment before progression, intolerance or transplantation.

INQOVI’s principal economic advantage is reduced administration burden. Oral treatment can eliminate infusion-center visits and some associated nursing and facility costs. That value is most relevant for patients living far from treatment centers, those with limited mobility and community oncology practices seeking to reduce infusion capacity requirements.

The drug does not remove the monitoring burden. Patients still require blood-count monitoring, infection management, transfusion support and dose adjustments. Severe neutropenia, thrombocytopenia, anemia and febrile neutropenia remain central treatment risks under the FDA label.

What is the financial trajectory for INQOVI?

Taiho Oncology does not provide a consistently separated, audited INQOVI revenue series in the manner used by large publicly traded pharmaceutical companies for major brands. Public disclosures from Taiho and its parent group generally emphasize consolidated or portfolio-level performance. A precise year-by-year INQOVI revenue trajectory therefore cannot be established from standard public financial statements.

The commercial trajectory is best characterized as follows:

Period	Commercial development	Financial implication
2020	FDA approval and initial launch	Limited first-year contribution because of launch timing and early commercial buildout
2021-2022	Expansion across academic and community oncology sites	Revenue growth driven by treatment adoption and conversion from IV decitabine
2023-2024	More established prescribing base	Growth increasingly dependent on new-patient penetration, persistence and reimbursement
2025-2027	Orphan exclusivity period continues	Highest-value period for defending price, access and market share
2028 onward	Regulatory exclusivity expires; patent protection remains relevant	Generic litigation and settlement timing become the primary valuation variables
Mid-2030s	Core composition and formulation patent horizon approaches	Long-term erosion risk increases unless follow-on products or new indications extend the franchise

INQOVI’s revenue profile is likely to be more sensitive to patient volume and persistence than to broad market expansion. The product operates in a disease area where treatment is specialist-driven and the eligible population is smaller than in major solid-tumor markets.

The largest near-term financial risk is not immediate generic substitution. It is slower-than-expected conversion from intravenous therapy, especially where hospitals and practices already have established decitabine and azacitidine workflows.

When does INQOVI lose FDA exclusivity?

INQOVI received orphan-drug designation for its approved disease indications. The FDA’s orphan-drug exclusivity period is seven years from approval, placing the principal regulatory exclusivity endpoint in July 2027. Orphan exclusivity prevents approval of the same drug for the same indication, subject to statutory exceptions, but it does not block all alternative products or all patent challenges.

INQOVI also received FDA approval based on clinical investigations supporting the combination and its oral exposure profile. Any applicable three-year exclusivity attached to new clinical investigations would not extend the seven-year orphan exclusivity period.

Protection type	Relevant date or period	Commercial effect
FDA approval	July 7, 2020	Commercial launch authorization
Orphan-drug exclusivity	Through approximately July 7, 2027	Restricts approval of the same drug for the same protected indication
Patent protection	At least into the mid-2030s based on core listed rights	Can block or delay generic launch after regulatory exclusivity
Pediatric exclusivity	No generally established extension identified in the core public approval record	No assumed six-month extension

What patents protect INQOVI?

INQOVI’s patent estate is built around the decitabine-cedazuridine combination, oral pharmaceutical compositions and methods of treatment. The commercial protection is stronger than the protection for decitabine alone because cedazuridine enables oral delivery by inhibiting cytidine deaminase and increasing systemic exposure to decitabine.

The relevant patent categories are:

• Fixed-dose or co-administered decitabine and cedazuridine compositions
• Oral dosage forms and pharmaceutical formulations
• Methods for treating MDS and related myeloid malignancies
• Dosing regimens designed to provide exposure comparable to intravenous decitabine
• Use of a cytidine-deaminase inhibitor to improve oral decitabine bioavailability

A representative Orange Book-listed U.S. patent associated with the product is U.S. Patent No. 10,702,541. Public patent records place the core U.S. protection in the mid-2030s, subject to applicable patent-term calculations and any regulatory extensions. The operative analysis should distinguish between the nominal expiration date, the Orange Book-listed expiration date and any patent-term adjustment.

The strongest commercial claim is the combination of cedazuridine with decitabine in an oral regimen. A generic developer may seek to avoid narrower formulation or dosing claims while still challenging broader composition or method claims.

What is the Orange Book status of INQOVI?

INQOVI is listed in the FDA Orange Book as a prescription drug with patent and exclusivity information associated with its approved product. The listing gives generic applicants the basis for assessing whether an abbreviated new drug application would require a Paragraph IV certification.

The principal legal issue is whether a generic decitabine/cedazuridine product can be approved before expiration of the listed patents. A generic applicant could certify that a listed patent is invalid, unenforceable or not infringed. That certification would constitute a Paragraph IV notice to the patent holder and could trigger patent litigation.

Orange Book status does not guarantee that all listed patents will survive litigation. It also does not prevent a generic company from designing a product around a specific formulation or method-of-use claim.

Which companies are challenging INQOVI?

No major publicly established Paragraph IV challenge or final generic approval for decitabine/cedazuridine had become a central market event in the public record through the latest broadly available information. The most likely challengers are generic companies with oncology manufacturing and oral solid-dose capabilities, including firms that already sell generic azacitidine or decitabine products.

Potential challengers would evaluate:

• The cost of developing a bioequivalent oral product
• Whether the reference product’s combination claims can be avoided
• The remaining market after July 2027
• The probability of patent litigation
• The size of the MDS and CMML patient pool
• Reimbursement and specialty-distribution requirements

The relatively small market may reduce the number of challengers compared with high-volume primary-care drugs. Patent litigation economics can still support a challenge if the generic manufacturer expects a first-filer advantage or a negotiated launch date.

What generic entry risks exist for INQOVI?

The most likely generic launch scenarios are:

Scenario 1: No challenge before July 2027

A generic applicant waits until regulatory exclusivity has expired and launches after resolving or accepting the remaining patent barriers. This is the lowest-litigation scenario but could still produce a launch before core patent expiration if the applicant certifies non-infringement or invalidity.

Scenario 2: Paragraph IV litigation and settlement

A generic applicant files before patent expiration, Taiho sues within the statutory window and the parties agree to a delayed launch. The settlement date would determine most of the value transfer. A launch several years before the mid-2030s patent horizon would materially reduce INQOVI’s value.

Scenario 3: Successful early challenge

A court invalidates or finds non-infringement of the key listed patents. This would create the highest downside risk because oral generic substitution could begin soon after regulatory barriers expire.

Scenario 4: Limited initial generic competition

Only one or two generics launch, with restricted substitution because of specialty distribution, payer controls or clinical reluctance. Price erosion would be slower than in a mass-market tablet category, but net price would still decline.

How strong is the INQOVI patent estate?

The estate is commercially meaningful because the product’s value depends on the combined use of two ingredients, not decitabine monotherapy. Cedazuridine provides a functional role in overcoming the oral absorption and metabolism limitations of decitabine.

Strengths include:

• Product differentiation tied to the combination mechanism
• Clinical support for oral exposure comparable to intravenous decitabine
• A treatment regimen that is difficult to replicate through a simple decitabine-only formulation
• Patent life extending materially beyond the July 2027 orphan-exclusivity date

Weaknesses include:

• The underlying therapeutic role of decitabine is established
• Some claims may be vulnerable to obviousness arguments involving oral decitabine and cytidine-deaminase inhibition
• Method-of-use patents can be difficult to enforce against physician prescribing
• Generic applicants may attempt to design around narrower formulation claims
• The market is sufficiently specialized that a successful challenge could attract substantial share quickly

Overall, the estate is stronger than a conventional reformulation estate but weaker than a broad new-molecular-entity estate covering a novel active ingredient.

What licensing deals support INQOVI?

INQOVI was developed through the Astex Pharmaceuticals and Taiho/Otsuka ecosystem. Astex discovered and developed cedazuridine-based approaches, while Taiho Oncology commercialized the product in the United States. The commercial structure gives Taiho access to the product while preserving economic participation for the originating development organization through royalties or related payments.

This arrangement affects financial analysis in two ways:

• Taiho’s product economics include commercialization, sales-force and distribution costs.
• Astex/Otsuka-related entities may recognize royalty or collaboration income rather than gross product sales.

The absence of a complete public product-level income statement makes it difficult to calculate INQOVI’s exact gross margin, royalty burden or contribution margin.

What litigation affects INQOVI?

No widely reported, dispositive patent judgment had established an early generic launch date for INQOVI in the public record available through the latest established information. The key future litigation trigger is a Paragraph IV notice involving an Orange Book-listed composition, formulation or method patent.

A litigation review should track:

• Paragraph IV notice dates
• The 45-day period for filing an infringement action
• The resulting 30-month stay, where applicable
• Patent validity and claim-construction rulings
• Any settlement or authorized-generic provisions
• FDA tentative and final approvals for competing products

Until a challenge is filed, the principal valuation assumption remains protected commercialization through the July 2027 orphan-exclusivity endpoint and potential patent protection into the mid-2030s.

How does INQOVI compare with intravenous decitabine and azacitidine?

Factor	INQOVI	IV decitabine	Azacitidine
Administration	Oral	Infusion	IV or subcutaneous
Treatment burden	Lower administration burden	High clinic burden	Moderate to high
Active-agent familiarity	Decitabine-based	Decitabine	Azacitidine
Main advantage	Convenience and exposure matching	Established use	Broad clinical familiarity
Main limitation	Oral adherence, cytopenias, cost	Infusion logistics	Repeated injections or infusions
Generic pressure	Delayed by combination patents and exclusivity	High in many markets	High in many markets
Commercial differentiation	Strongest on route and regimen	Weak after genericization	Strong clinical familiarity

INQOVI’s primary defense is convenience rather than a new mechanism. Its performance depends on whether clinicians and payers assign enough value to oral administration to offset the branded price.

What is the outlook for INQOVI revenue and market share?

The base case is a gradual commercial build followed by a mature specialty-oncology revenue profile. Revenue should remain supported by:

• Continued incidence of MDS and CMML
• Long treatment duration in responders
• Patient preference for oral therapy
• Community oncology adoption
• Limited near-term competition from equivalent oral products

Pressure points are:

• Generic IV decitabine and azacitidine pricing
• Payer restrictions and specialty-pharmacy controls
• Treatment discontinuation from cytopenias or progression
• Limited use in patients proceeding rapidly to transplant
• Potential generic challenges after July 2027
• Lack of broad label expansion into larger oncology populations

INQOVI is therefore more likely to be a durable specialty product than a mass-market growth asset. The value inflection point is the period from 2027 through the first generic settlement or court decision. Patent validity, settlement terms and any authorized-generic strategy will have greater financial importance than near-term prescription growth once the product reaches commercial maturity.

Key Takeaways

• INQOVI is an oral decitabine/cedazuridine product approved for MDS and CMML.
• Its commercial differentiation is the replacement of five days of IV decitabine with five days of oral treatment.
• Orphan-drug exclusivity runs through approximately July 2027.
• Core patent protection is expected to extend into the mid-2030s, subject to patent-term calculations and litigation.
• Taiho does not provide a consistently separated public revenue series sufficient to establish exact annual INQOVI sales.
• The principal competitive threat is generic or low-cost hypomethylating-agent therapy, not another identical oral product.
• A Paragraph IV filing, patent settlement or authorized-generic agreement would be the largest identifiable value catalyst.
• INQOVI’s patent estate is stronger than a routine reformulation estate because cedazuridine is functionally required for the oral decitabine strategy.
• The product’s long-term value depends on conversion from IV therapy, treatment persistence and the timing of generic entry.

FAQs

Is INQOVI a chemotherapy drug?

INQOVI is an antineoplastic hypomethylating-agent combination. Decitabine is a cytidine analog that alters DNA methylation and affects malignant hematopoietic-cell growth.

Is INQOVI interchangeable with DACOGEN?

INQOVI is not automatically interchangeable with intravenous DACOGEN. It is designed to provide decitabine exposure comparable to a five-day intravenous regimen, but route, dosing, adherence and patient monitoring differ.

Does INQOVI have a biosimilar risk?

No. INQOVI is a small-molecule drug, not a biologic. Its competitive risk comes from generic small-molecule products, not biosimilars.

Can a generic manufacturer copy the INQOVI tablet after 2027?

A generic manufacturer may pursue approval after applicable regulatory exclusivity expires, but Orange Book-listed patents can delay approval or trigger Paragraph IV litigation. The launch date depends on patent validity, infringement, settlement and FDA approval.

What is the main commercial advantage of cedazuridine in INQOVI?

Cedazuridine inhibits cytidine deaminase, an enzyme that breaks down decitabine. This increases oral decitabine exposure and enables a clinically useful oral regimen.

References

1. U.S. Food and Drug Administration. (2020). INQOVI prescribing information.
2. U.S. Food and Drug Administration. (2020, July 7). FDA approves new oral drug for certain patients with myelodysplastic syndromes.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. Patent No. 10,702,541. (2020). Pharmaceutical compositions and methods comprising decitabine and cedazuridine.
5. U.S. Food and Drug Administration. (2020). INQOVI approval letter and orphan-drug designation records.
6. National Cancer Institute. (2024). Myelodysplastic syndromes treatment information.
7. Astex Pharmaceuticals. (2024). Corporate and product information for cedazuridine-based therapies.

DrugChatter Q&A for INQOVI

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