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INQOVI Drug Patent Profile

When do Inqovi patents expire, and what generic alternatives are available?

Inqovi is a drug marketed by Otsuka and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-two patent family members in thirty-nine 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.

Indicators of Generic Entry

Summary for INQOVI

International Patents:	62
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	25
Drug Prices:	Drug price information 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
Astex Pharmaceuticals, Inc.	Phase 1
Pamela Munster	Phase 1
The University of New South Wales	Phase 1

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 eight 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
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes			Y
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes				Y
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes				Y
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes
Otsuka	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
Austria	E548374
European Patent Office	2447272	2'-FLUORO-2'-DEOXYTÉTRAHYDROURIDINES EN TANT QU'INHIBITEURS DE DÉSAMINASE DE LA CYTIDINE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Australia	2008312435	2 ' -flu0r0-2 ' -deoxytetrahydrouridines as cytidine deaminase inhibitors
Ecuador	SP10010095	2'-FLUORO-2'-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Norway	2023047
Netherlands	301256
Brazil	112022013264	COMBINAÇÃO DE FORMAS DE DOSAGEM ORAL SÓLIDA DE DECITABINA E CEDAZURIDINA

Supplementary Protection Certificates for INQOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	LUC00327	Luxembourg		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786	122023000069	Germany		PRODUCT NAME: ZUSAMMENSETZUNG UMFASSEND: CEDAZURIDIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; UND DECITABIN; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786	301257	Netherlands		PRODUCT NAME: SAMENSTELLING WELKE OMVAT: 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	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
2207786	301256	Netherlands		PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918

INQOVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INQOVI

Introduction to INQOVI

INQOVI, a combination of decitabine and cedazuridine, is a significant advancement in the treatment of myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). Approved by the U.S. Food and Drug Administration in July 2020, INQOVI offers an oral alternative to traditional intravenous decitabine therapy, marking a substantial improvement in patient care.

Market Drivers

Increasing Prevalence of MDS

The global market for MDS treatments is driven by the rising prevalence of MDS, a type of blood cancer. As the population ages, the incidence of MDS is expected to increase, thereby boosting the demand for effective treatments like INQOVI[3].

Advancements in Drug Development

The approval of INQOVI is part of a broader trend of advancements in drug development for MDS. Novel therapies and product approvals, such as INQOVI, are expanding treatment options and improving patient outcomes. This trend is expected to continue, driving market growth[3].

Improved Diagnosis and Treatment Accessibility

Enhanced diagnostic techniques and increased accessibility of treatments in major nations are also driving the market. The ease of administration of oral treatments like INQOVI, compared to intravenous therapies, is a significant factor in this growth[1].

Market Expansion and Growth Projections

Global Market Size and Growth Rate

The global MDS treatment market, which includes drugs like INQOVI, is projected to grow significantly. In 2022, the market size was estimated at USD 2.3 billion and is expected to expand at a compound annual growth rate (CAGR) of 9.5% until 2032, reaching a forecasted revenue of USD 5.79 billion[1].

Regional Market Dynamics

North America currently holds the largest market share for MDS drugs, including INQOVI, due to high prevalence rates, early adoption of innovative treatments, and substantial investments in drug development. However, the Asia Pacific region is projected to experience the fastest growth rate over the forecast period[1].

Financial Trajectory

Revenue Impact

The approval and market entry of INQOVI have contributed to the revenue growth of companies involved in its development and distribution. For instance, the approval of INQOVI has been a significant factor in the financial performance of companies like Astex Pharmaceuticals, which developed the drug in collaboration with other pharmaceutical firms[4].

Cost and Pricing

The cost-effectiveness of INQOVI compared to traditional intravenous therapies can influence its adoption rate. While the exact pricing details are not publicly disclosed, the convenience and reduced healthcare facility visits associated with oral administration are likely to make INQOVI an attractive option for both patients and healthcare providers.

Clinical Efficacy and Safety Profile

Clinical Trials and Outcomes

INQOVI's efficacy was established through two open-label, randomized studies: a Phase II and a Phase III study. These studies showed that INQOVI had a comparable safety and efficacy profile to intravenous decitabine. The Phase III study reported a complete response in 21% of patients, with a median duration of complete response of 7.5 months[4].

Patient Outcomes

The drug has significantly improved patient outcomes by reducing the need for red blood cell and platelet transfusions. For example, 53% of patients who were dependent on transfusions at baseline became independent during the treatment period[4].

Challenges and Limitations

Side Effects and Toxicity

Despite its benefits, INQOVI, like other MDS treatments, is associated with side effects that can impede market growth. The safety profile of INQOVI includes common adverse effects such as nausea, vomiting, and fatigue, which may lead to treatment discontinuation in some cases[4].

COVID-19 Pandemic Impact

The COVID-19 pandemic has had a significant impact on the MDS treatment market, including the adoption of INQOVI. The pandemic disrupted standard care and affected patient access to necessary treatments, although ongoing vaccination efforts and decreasing COVID-19 cases are expected to support the market's recovery[3].

Competitive Landscape

Key Players

The MDS treatment market is competitive, with major players such as Bristol-Myers Squibb, AbbVie, and Takeda Pharmaceutical Company Limited. These companies are actively expanding their market presence through strategic partnerships and collaborations, which can influence the financial trajectory of INQOVI[3].

Market Share and Positioning

INQOVI's market share is part of the broader hypomethylating agents segment, which includes other drugs like Azacitidine (Vidaza) and Decitabine (Dacogen). The unique selling proposition of INQOVI as an oral treatment positions it favorably in the market, especially in regions with advanced healthcare infrastructures[1].

Key Takeaways

• Growing Market Demand: The global MDS treatment market is expected to grow significantly, driven by rising prevalence, improved diagnosis, and new drug approvals.
• Regional Growth: North America leads the market, but the Asia Pacific region is expected to experience the fastest growth rate.
• Clinical Efficacy: INQOVI has shown comparable efficacy to intravenous decitabine with the convenience of oral administration.
• Financial Impact: The approval of INQOVI contributes to revenue growth for involved companies and offers a cost-effective treatment option.
• Challenges: Side effects and the impact of the COVID-19 pandemic are potential limitations to market growth.

FAQs

What is INQOVI, and how does it differ from traditional MDS treatments?

INQOVI is an oral combination of decitabine and cedazuridine, approved for the treatment of MDS and CMML. It differs from traditional treatments by offering an oral alternative to intravenous decitabine therapy, enhancing patient convenience and reducing the need for healthcare facility visits.

What are the key drivers of the MDS treatment market growth?

The market growth is driven by the rising prevalence of MDS, advancements in drug development, improved diagnosis, and increased accessibility of treatments.

How has the COVID-19 pandemic impacted the MDS treatment market?

The pandemic disrupted standard care and affected patient access to necessary treatments, but ongoing vaccination efforts and decreasing COVID-19 cases are expected to support the market's recovery.

What is the projected growth rate of the global MDS treatment market?

The global MDS treatment market is expected to grow at a CAGR of 9.5% from 2023 to 2032.

Which region is expected to experience the fastest growth in the MDS treatment market?

The Asia Pacific region is projected to experience the fastest growth rate over the forecast period.

Sources

1. Market.us: Myelodysplastic Syndrome Drug Market Size | CAGR of 9.5% https://market.us/report/myelodysplastic-syndrome-drug-market/
2. INOVIO: INOVIO Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights https://ir.inovio.com/news-releases/news-releases-details/2024/INOVIO-Reports-Fourth-Quarter-and-Full-Year-2023-Financial-Results-and-Operational-Highlights/default.aspx
3. Mordor Intelligence: Myelodysplastic Syndrome (MDS) Treatment Market Size https://www.mordorintelligence.com/industry-reports/myelodysplastic-syndrome-treatment-market/market-size
4. Health Canada: Summary Basis of Decision for Inqovi https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00496