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Last Updated: December 23, 2024

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inqovi Drug Patent Profile


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When do Inqovi patents expire, and when can generic versions of Inqovi launch?

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

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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
Drug patent expirations by year for inqovi
Drug Prices for inqovi

See drug prices for inqovi

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for inqovi
Generic Entry Date for inqovi*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Astex Pharmaceuticals, Inc.Phase 1
Pamela MunsterPhase 1
Clinical Hub for Interventional Research (CHOIR)Phase 1

See all inqovi clinical trials

Pharmacology for inqovi

US Patents and Regulatory Information for inqovi

inqovi is protected by eight US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of inqovi is ⤷  Subscribe.

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
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes 8,618,075 ⤷  Subscribe ⤷  Subscribe
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes 11,963,971 ⤷  Subscribe Y ⤷  Subscribe
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes 9,567,363 ⤷  Subscribe Y ⤷  Subscribe
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes 8,268,800 ⤷  Subscribe Y ⤷  Subscribe
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 08312435
Patent: 2 ' -flu0r0-2 ' -deoxytetrahydrouridines as cytidine deaminase inhibitors
Estimated Expiration: ⤷  Subscribe

Austria

Patent: 48374
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 0818672
Patent: 2'-fluor-2'-desoxitetra-hidrouridinas como inibidores da citidina desaminase
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 02274
Patent: CERTAINS COMPOSES, COMPOSITIONS ET PROCEDES (2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

China

Patent: 1827856
Patent: 2 ' -flu0r0-2 ' -deoxytetrahydrouridines as cytidine deaminase inhibitors
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 70330
Patent: 2-FLUORO-2`-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 427
Patent: 2-FLUORO-2 - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0120419
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 12781
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 07786
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 10010095
Patent: 2'-FLUORO-2'-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 8757
Patent: 2'-ФТОР-2'-ДЕЗОКСИТЕТРАГИДРОУРИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ЦИТИДИНДЕАМИНАЗЫ (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 1000642
Patent: 2'-ФТОР-2'-ДЕЗОКСИТЕТРАГИДРОУРИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ЦИТИДИНДЕАМИНАЗЫ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 07786
Patent: 2'-FLUORO-2'-DÉSOXYTETRAHYDROURIDINES COMME INHIBITEURS DE CYTIDINE DÉSAMINASE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Patent: 47272
Patent: 2'-FLUORO-2'-DEOXYTÉTRAHYDROURIDINES EN TANT QU'INHIBITEURS DE DÉSAMINASE DE LA CYTIDINE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Finland

Patent: 0230039
Estimated Expiration: ⤷  Subscribe

Patent: 0230040
Estimated Expiration: ⤷  Subscribe

France

Patent: C1051
Estimated Expiration: ⤷  Subscribe

Patent: C1052
Estimated Expiration: ⤷  Subscribe

Guatemala

Patent: 1000088
Patent: 2 -FLUORO-2 ́DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 46410
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 300044
Estimated Expiration: ⤷  Subscribe

Patent: 300045
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 4732
Patent: @@@@@-דיפלואורו-@@-דאוקסי@טטראהידרו אורידינים, תכשירים המכילים אותם והשימוש בהם להכנת@תרופות (2',2'-difluoro-2'-deoxytetrahydrouridine, compositions comprising the same and uses thereof in the preparation of medicaments)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 96899
Estimated Expiration: ⤷  Subscribe

Patent: 59588
Estimated Expiration: ⤷  Subscribe

Patent: 11500713
Estimated Expiration: ⤷  Subscribe

Patent: 14177455
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINE AS CYTIDINE DEAMINASE INHIBITOR
Estimated Expiration: ⤷  Subscribe

Jordan

Patent: 78
Patent: مركبات وتركيبات وطرق معينة (Certain Compounds, Compositions and Methods)
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 7970
Patent: 2'-FLUORO-2'DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 10004109
Patent: 2'-FLUORO-2'-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA. (2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS.)
Estimated Expiration: ⤷  Subscribe

Montenegro

Patent: 997
Patent: 2'-FLUOR-2 ' -DEOKSITETRAHIDROURIDINI KAO INHIBITORI CITIDIN DEAMINAZE (2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Netherlands

Patent: 1256
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 4229
Patent: 2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Nicaragua

Patent: 1000055
Patent: 2' - FLUORO - 2' - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA.
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 23047
Estimated Expiration: ⤷  Subscribe

Patent: 23048
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 07786
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 07786
Estimated Expiration: ⤷  Subscribe

Saudi Arabia

Patent: 290661
Patent: 2' - فلورو -2' - ديوكسي تترا هيدرو يوريدين كمثبطات سيتيدين دياميناز (2'-Fluoro-2' Deoxytetrahydrouridines as Cytidine Deaminase Inhibitors)
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 323
Patent: 2'-FLUORO-2'-DEOKSITETRAHIDROURIDINI KAO INHIBITORI CITIDIN DEAMINAZE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 07786
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1002178
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1543049
Estimated Expiration: ⤷  Subscribe

Patent: 100091978
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 84011
Estimated Expiration: ⤷  Subscribe

Patent: 16566
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 45539
Estimated Expiration: ⤷  Subscribe

Patent: 0924786
Patent: Certain compounds, compositions and methods
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 476
Patent: 2'-ФТОР-2'-ДЕОКСИТЕТРАГІДРОУРИДИНИ ЯК ІНГІБІТОРИ ЦИТИДИНДЕАМІНАЗИ[2'-ФТОР-2'-ДЕОКСИТЕТРАГИДРОУРИДИНЫ КАК ИНГИБИТОРЫ ЦИТИДИНДЕАМИНАЗЫ (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷  Subscribe

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 ⤷  Subscribe
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) ⤷  Subscribe
Australia 2008312435 2 ' -flu0r0-2 ' -deoxytetrahydrouridines as cytidine deaminase inhibitors ⤷  Subscribe
Ecuador SP10010095 2'-FLUORO-2'-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA ⤷  Subscribe
Norway 2023047 ⤷  Subscribe
Netherlands 301256 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for inqovi

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2207786 LUC00327 Luxembourg ⤷  Subscribe PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786 122023000069 Germany ⤷  Subscribe PRODUCT NAME: ZUSAMMENSETZUNG UMFASSEND: CEDAZURIDIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; UND DECITABIN; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786 301257 Netherlands ⤷  Subscribe 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 ⤷  Subscribe PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918
2207786 PA2023539 Lithuania ⤷  Subscribe 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 ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.