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Last Updated: November 21, 2024

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IDHIFA Drug Patent Profile


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

Idhifa is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and eleven patent family members in thirty-nine countries.

The generic ingredient in IDHIFA is enasidenib mesylate. One supplier is listed for this compound. Additional details are available on the enasidenib mesylate profile page.

DrugPatentWatch® Generic Entry Outlook for Idhifa

Idhifa was eligible for patent challenges on August 1, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 16, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for IDHIFA
Drug Prices for IDHIFA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IDHIFA
Generic Entry Date for IDHIFA*:
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 IDHIFA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ChicagoPhase 1
University Health Network, TorontoPhase 1/Phase 2
AbbViePhase 1/Phase 2

See all IDHIFA clinical trials

Pharmacology for IDHIFA

US Patents and Regulatory Information for IDHIFA

IDHIFA is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IDHIFA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 IDHIFA

Therapeutically active compounds and their methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION

Therapeutically active compounds and their methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION

Methods and compositions for cell-proliferation-related disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION

Therapeutically active compositions and their methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION

Therapeutically active compounds and their methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Therapeutically active compounds and their methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting IDHIFA

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb IDHIFA enasidenib mesylate TABLET;ORAL 209606-001 Aug 1, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bristol Myers Squibb IDHIFA enasidenib mesylate TABLET;ORAL 209606-001 Aug 1, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb IDHIFA enasidenib mesylate TABLET;ORAL 209606-001 Aug 1, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 IDHIFA

When does loss-of-exclusivity occur for IDHIFA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 0411
Patent: COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 13207289
Patent: Therapeutically active compounds and their methods of use
Estimated Expiration: ⤷  Sign Up

Patent: 17265096
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014016805
Patent: compostos terapeuticamente ativos e seus métodos de uso
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 60623
Patent: COMPOSES THERAPEUTIQUEMENT ACTIFS ET LEURS PROCEDES D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 14001793
Patent: Compuestos derivados de 1,3,5-triazinas sustituidas y sus sales, como inhibidores de la idh2 mutante; composicion farmaceutica que los comprende; y su uso para el tratamiento del cancer.
Estimated Expiration: ⤷  Sign Up

China

Patent: 4114543
Patent: Therapeutically active compounds and their methods of use
Estimated Expiration: ⤷  Sign Up

Patent: 7417667
Patent: 治疗活性化合物及其使用方法 (Therapeutically active compounds and their methods of use)
Estimated Expiration: ⤷  Sign Up

Patent: 8912066
Patent: 治疗活性化合物及其使用方法 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Patent: 4933585
Patent: 治疗活性化合物及其使用方法 (Therapeutically active compounds and methods of use thereof)
Estimated Expiration: ⤷  Sign Up

Patent: 5521264
Patent: 治疗活性化合物及其使用方法 (Therapeutically active compounds and methods of use thereof)
Estimated Expiration: ⤷  Sign Up

Patent: 5536635
Patent: 治疗活性化合物及其使用方法 (Therapeutically active compounds and methods of use thereof)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 30962
Patent: Compuestos terapéuticamente activos y sus métodos de uso
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 140377
Patent: COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0180844
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 20506
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 00743
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 14012726
Patent: COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 0187
Patent: ТЕРАПЕВТИЧЕСКИ АКТИВНЫЕ СОЕДИНЕНИЯ И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ (THERAPEUTICALLY ACTIVE COMPOUNDS AND METHODS OF USE THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 1491330
Patent: ТЕРАПЕВТИЧЕСКИ АКТИВНЫЕ СОЕДИНЕНИЯ И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 00743
Patent: COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS PROCÉDÉS D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Patent: 06608
Patent: COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS PROCÉDÉS D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Patent: 84997
Patent: COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS PROCÉDÉS D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 03942
Patent: 治療活性化合物及其使用方法 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 38403
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3503
Patent: מדכאי איזוציטראט דהידרוגנאז, תכשירים המכילים אותם ושימושים בהם (Isocitrate dehydrogenase inhibitors, compositions comprising same and uses thereof)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 09081
Estimated Expiration: ⤷  Sign Up

Patent: 11895
Estimated Expiration: ⤷  Sign Up

Patent: 15503571
Patent: 治療活性化合物およびその使用方法
Estimated Expiration: ⤷  Sign Up

Patent: 17075193
Patent: 治療活性化合物およびその使用方法 (THERAPEUTICALLY ACTIVE COMPOSITIONS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 00743
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 5206
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 8940
Patent: COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE.)
Estimated Expiration: ⤷  Sign Up

Patent: 14008350
Patent: COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 7096
Patent: Triazinyl compounds and their methods of use
Estimated Expiration: ⤷  Sign Up

Patent: 2582
Patent: Methods of preparing 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{ [2-(trifluoromethyl)pyridin-4-yl]amino} -1,3,5-triazin-2-yl)amino]propan-2-ol
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1400073
Patent: COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODO
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 97546
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 142098
Patent: COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 014501561
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 00743
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 00743
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 401
Patent: TERAPEUTSKI AKTIVNA JEDINJENJA I POSTUPCI ZA NJIHOVU UPOTREBU (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201602862R
Patent: Therapeutically Active Compounds And Their Methods Of Use
Estimated Expiration: ⤷  Sign Up

Patent: 201403878Q
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 00743
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1405163
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1893112
Estimated Expiration: ⤷  Sign Up

Patent: 140113712
Patent: THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 75760
Estimated Expiration: ⤷  Sign Up

Patent: 01430
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 53228
Estimated Expiration: ⤷  Sign Up

Patent: 1329054
Patent: Therapeutically active compounds and their methods of use
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1809228
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 7451
Patent: ТЕРАПЕВТИЧНО АКТИВНІ СПОЛУКИ І СПОСОБИ ЇХ ЗАСТОСУВАННЯ (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

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 IDHIFA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2406389 PROCÉDÉS ET COMPOSITIONS POUR DES TROUBLES LIÉS À LA PROLIFÉRATION CELLULAIRE (METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS) ⤷  Sign Up
China 105916507 治疗活性化合物及其使用方法 (Therapeutically active compounds and their methods of use) ⤷  Sign Up
European Patent Office 2800743 COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS PROCÉDÉS D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE) ⤷  Sign Up
>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.