INQOVI Drug Patent Profile
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Which patents cover Inqovi, 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 |


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
Sponsor | Phase |
---|---|
Astex Pharmaceuticals, Inc. | Phase 1 |
Pamela Munster | Phase 1 |
Australian National University | Phase 1 |
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of INQOVI is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
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 | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Otsuka | INQOVI | cedazuridine; decitabine | TABLET;ORAL | 212576-001 | Jul 7, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Otsuka | INQOVI | cedazuridine; decitabine | TABLET;ORAL | 212576-001 | Jul 7, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Otsuka | INQOVI | cedazuridine; decitabine | TABLET;ORAL | 212576-001 | Jul 7, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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: ⤷ Try for Free
Austria
Patent: 48374
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0818672
Patent: 2'-fluor-2'-desoxitetra-hidrouridinas como inibidores da citidina desaminase
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 02274
Patent: CERTAINS COMPOSES, COMPOSITIONS ET PROCEDES (2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷ Try for Free
China
Patent: 1827856
Patent: 2 ' -flu0r0-2 ' -deoxytetrahydrouridines as cytidine deaminase inhibitors
Estimated Expiration: ⤷ Try for Free
Colombia
Patent: 70330
Patent: 2-FLUORO-2`-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷ Try for Free
Costa Rica
Patent: 427
Patent: 2-FLUORO-2 - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0120419
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 12781
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 07786
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 10010095
Patent: 2'-FLUORO-2'-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 8757
Patent: 2'-ФТОР-2'-ДЕЗОКСИТЕТРАГИДРОУРИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ЦИТИДИНДЕАМИНАЗЫ (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷ Try for Free
Patent: 1000642
Patent: 2'-ФТОР-2'-ДЕЗОКСИТЕТРАГИДРОУРИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ЦИТИДИНДЕАМИНАЗЫ
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Finland
Patent: 0230039
Estimated Expiration: ⤷ Try for Free
Patent: 0230040
Estimated Expiration: ⤷ Try for Free
France
Patent: C1051
Estimated Expiration: ⤷ Try for Free
Patent: C1052
Estimated Expiration: ⤷ Try for Free
Guatemala
Patent: 1000088
Patent: 2 -FLUORO-2 ́DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 46410
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 300044
Estimated Expiration: ⤷ Try for Free
Patent: 300045
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Japan
Patent: 96899
Estimated Expiration: ⤷ Try for Free
Patent: 59588
Estimated Expiration: ⤷ Try for Free
Patent: 11500713
Estimated Expiration: ⤷ Try for Free
Patent: 14177455
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINE AS CYTIDINE DEAMINASE INHIBITOR
Estimated Expiration: ⤷ Try for Free
Jordan
Patent: 78
Patent: مركبات وتركيبات وطرق معينة (Certain Compounds, Compositions and Methods)
Estimated Expiration: ⤷ Try for Free
Malaysia
Patent: 7970
Patent: 2'-FLUORO-2'DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 10004109
Patent: 2'-FLUORO-2'-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA. (2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS.)
Estimated Expiration: ⤷ Try for Free
Montenegro
Patent: 997
Patent: 2'-FLUOR-2 ' -DEOKSITETRAHIDROURIDINI KAO INHIBITORI CITIDIN DEAMINAZE (2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷ Try for Free
Netherlands
Patent: 1256
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 4229
Patent: 2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷ Try for Free
Nicaragua
Patent: 1000055
Patent: 2' - FLUORO - 2' - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA.
Estimated Expiration: ⤷ Try for Free
Norway
Patent: 23047
Estimated Expiration: ⤷ Try for Free
Patent: 23048
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 07786
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 07786
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Serbia
Patent: 323
Patent: 2'-FLUORO-2'-DEOKSITETRAHIDROURIDINI KAO INHIBITORI CITIDIN DEAMINAZE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 07786
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1002178
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1543049
Estimated Expiration: ⤷ Try for Free
Patent: 100091978
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 84011
Estimated Expiration: ⤷ Try for Free
Patent: 16566
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 45539
Estimated Expiration: ⤷ Try for Free
Patent: 0924786
Patent: Certain compounds, compositions and methods
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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 |
---|---|---|---|
Taiwan | 200924786 | Certain compounds, compositions and methods | ⤷ Try for Free |
Australia | 2008312435 | 2 ' -flu0r0-2 ' -deoxytetrahydrouridines as cytidine deaminase inhibitors | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2009052287 | ⤷ Try for Free | |
European Patent Office | 4069254 | FORMES POSOLOGIQUES ORALES SOLIDES À BASE DE DÉITABINE ET DE CÉDÉURIDINE (COMBINATION DECITABINE AND CEDAZURIDINE SOLID ORAL DOSAGE FORMS) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INQOVI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2207786 | LUC00326 | Luxembourg | ⤷ Try for Free | 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 | 301256 | Netherlands | ⤷ Try for Free | PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918 |
2207786 | 2023C/550 | Belgium | ⤷ Try for Free | PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918 |
2207786 | 2023C/551 | Belgium | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for INQOVI
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