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
Summary for INQOVI
| International Patents: | 51 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 15 |
| Clinical Trials: | 20 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Australian National University | Phase 1 |
| Clinical Hub for Interventional Research (CHOIR) | Phase 1 |
| The University of New South Wales | Phase 1 |
Pharmacology for INQOVI
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ||||
| >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 |
|---|---|---|---|
| Nicaragua | 201000055 | 2' - FLUORO - 2' - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA. | ⤷ Try a Trial |
| Ecuador | SP10010095 | 2'-FLUORO-2'-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA | ⤷ Try a Trial |
| Costa Rica | 11427 | 2-FLUORO-2 - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA | ⤷ 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 | 122023000069 | Germany | ⤷ Try a Trial | PRODUCT NAME: ZUSAMMENSETZUNG UMFASSEND: CEDAZURIDIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; UND DECITABIN; REGISTRATION NO/DATE: EU/1/23/1756 20230915 |
| 2207786 | LUC00326 | Luxembourg | ⤷ Try a Trial | 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 | 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 |
| >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.
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