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Last Updated: April 21, 2024

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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 three patents protecting this drug.

This drug has fifty-one 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 will be eligible for patent challenges on July 7, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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
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
Clinical Hub for Interventional Research (CHOIR)Phase 1
The University of New South WalesPhase 1
Australian National UniversityPhase 1

See all INQOVI clinical trials

Pharmacology for INQOVI

US Patents and Regulatory Information for INQOVI

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INQOVI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Patents protecting INQOVI

Certain compounds, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF CHRONIC MYELOMONOCYTIC LEUKEMIA

Certain compounds, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MYELODYSPLASTIC SYNDROME

Certain compounds, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE

Certain compounds, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE

Certain compounds, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE

Certain compounds, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE

Certain compounds, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting INQOVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS), INCLUDING PREVIOUSLY TREATED AND UNTREATED, DE NOVO AND SECONDARY MDS WITH THE FOLLOWING FRENCH-AMERICAN-BRITISH SUBTYPES (REFRACTORY ANEMIA, REFRACTORY ANEMIA WITH RINGED SIDEROBLASTS, REFRACTORY ANEMIA WITH EXCESS BLASTS, AND CHRONIC MYELOMONOCYTIC LEUKEMIA [CMML]) AND INTERMEDIATE-1, INTERMEDIATE-2, AND HIGH-RISK INTERNATIONAL PROGNOSTIC SCORING SYSTEM GROUPS.
Exclusivity Expiration: ⤷  Try a Trial

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 a Trial ⤷  Try a Trial ⤷  Try a Trial
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 a Trial

Austria

Patent: 48374
Estimated Expiration: ⤷  Try a Trial

Brazil

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

Canada

Patent: 02274
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1827856
Patent: 2 ' -flu0r0-2 ' -deoxytetrahydrouridines as cytidine deaminase inhibitors
Estimated Expiration: ⤷  Try a Trial

Colombia

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

Costa Rica

Patent: 427
Patent: 2-FLUORO-2 - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120419
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 12781
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 07786
Estimated Expiration: ⤷  Try a Trial

Ecuador

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

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 a Trial

Patent: 1000642
Patent: 2'-ФТОР-2'-ДЕЗОКСИТЕТРАГИДРОУРИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ЦИТИДИНДЕАМИНАЗЫ
Estimated Expiration: ⤷  Try a Trial

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 a Trial

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 a Trial

Finland

Patent: 0230039
Estimated Expiration: ⤷  Try a Trial

Patent: 0230040
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1051
Estimated Expiration: ⤷  Try a Trial

Patent: C1052
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 1000088
Patent: 2 -FLUORO-2 ́DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 46410
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 300044
Estimated Expiration: ⤷  Try a Trial

Patent: 300045
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4732
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 96899
Estimated Expiration: ⤷  Try a Trial

Patent: 59588
Estimated Expiration: ⤷  Try a Trial

Patent: 11500713
Estimated Expiration: ⤷  Try a Trial

Patent: 14177455
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINE AS CYTIDINE DEAMINASE INHIBITOR
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 78
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7970
Patent: 2'-FLUORO-2'DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Try a Trial

Mexico

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

Montenegro

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

Netherlands

Patent: 1256
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4229
Patent: 2 ' -FLU0R0-2 ' -DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Try a Trial

Nicaragua

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

Norway

Patent: 23047
Estimated Expiration: ⤷  Try a Trial

Patent: 23048
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 07786
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 07786
Estimated Expiration: ⤷  Try a Trial

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 a Trial

Serbia

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

Slovenia

Patent: 07786
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1002178
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1543049
Estimated Expiration: ⤷  Try a Trial

Patent: 100091978
Patent: 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 84011
Estimated Expiration: ⤷  Try a Trial

Patent: 16566
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 45539
Estimated Expiration: ⤷  Try a Trial

Patent: 0924786
Estimated Expiration: ⤷  Try a Trial

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 a Trial

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
Jordan 2778 مركبات وتركيبات وطرق معينة (Certain Compounds, Compositions and Methods) ⤷  Try a Trial
Hungary S2300044 ⤷  Try a Trial
Spain 2384011 ⤷  Try a Trial
Colombia 6270330 2-FLUORO-2`-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA ⤷  Try a Trial
Slovenia 2207786 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INQOVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2207786 PA2023539 Lithuania ⤷  Try a Trial PRODUCT NAME: KOMPOZICIJA, APIMANTI: CEDAZURIDINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; IR DECITABINAS; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786 CA 2023 00038 Denmark ⤷  Try a Trial PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918
2207786 LUC00327 Luxembourg ⤷  Try a Trial PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786 PA2023538 Lithuania ⤷  Try a Trial PRODUCT NAME: CEDAZURIDINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786 CR 2023 00037 Denmark ⤷  Try a Trial PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.