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Last Updated: September 25, 2022

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 forty-two patent family members in thirty-four 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
International Patents:42
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 16
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
Drug patent expirations by year for INQOVI
Drug Prices for INQOVI

See drug prices for INQOVI

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Oregon Health and Science UniversityPhase 1
OHSU Knight Cancer InstitutePhase 1
Genentech, Inc.Phase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC MYELOMONOCYTIC LEUKEMIA

Certain compounds, compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MYELODYSPLASTIC SYNDROME

Certain compounds, compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE

Certain compounds, compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE

Certain compounds, compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR INHIBITING CYTIDINE DEAMINASE BY ADMINISTERING CEDAZURIDINE

Certain compounds, compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR INHIBITING DEGRADATION OF A CDA SUBSTRATE BY ADMINISTERING CEDAZURIDINE

Certain compounds, compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting INQOVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Austria

Patent: 8374
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0818672
Estimated Expiration: See Plans and Pricing

Canada

Patent: 02274
Estimated Expiration: See Plans and Pricing

China

Patent: 1827856
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 70330
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 427
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120419
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12781
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 07786
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010095
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8757
Estimated Expiration: See Plans and Pricing

Patent: 1000642
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 07786
Estimated Expiration: See Plans and Pricing

Patent: 47272
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1000088
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 46410
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4732
Estimated Expiration: See Plans and Pricing

Japan

Patent: 96899
Estimated Expiration: See Plans and Pricing

Patent: 59588
Estimated Expiration: See Plans and Pricing

Patent: 11500713
Estimated Expiration: See Plans and Pricing

Patent: 14177455
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 78
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7970
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10004109
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 997
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4229
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1000055
Estimated Expiration: See Plans and Pricing

Poland

Patent: 07786
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 07786
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 24
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 323
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 07786
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1002178
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1543049
Estimated Expiration: See Plans and Pricing

Patent: 100091978
Estimated Expiration: See Plans and Pricing

Spain

Patent: 84011
Estimated Expiration: See Plans and Pricing

Patent: 16566
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 45539
Estimated Expiration: See Plans and Pricing

Patent: 0924786
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 476
Estimated Expiration: See Plans and Pricing

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
Spain 2616566 See Plans and Pricing
Guatemala 201000088 2 -FLUORO-2 ́DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA See Plans and Pricing
Malaysia 147970 2'-FLUORO-2'DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS See Plans and Pricing
Japan 2014177455 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINE AS CYTIDINE DEAMINASE INHIBITOR See Plans and Pricing
Hong Kong 1146410 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS See Plans and Pricing
Taiwan 200924786 Certain compounds, compositions and methods See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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.