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Last Updated: May 28, 2022

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 Celgene Corp and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and five patent family members in thirty-eight 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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Summary for IDHIFA
International Patents:105
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 55
Clinical Trials: 11
Patent Applications: 72
Drug Prices: Drug price information for IDHIFA
What excipients (inactive ingredients) are in IDHIFA?IDHIFA excipients list
DailyMed Link:IDHIFA at DailyMed
Drug patent expirations by year for IDHIFA
Drug Prices for IDHIFA

See drug prices for IDHIFA

DrugPatentWatch® Estimated Generic Entry Opportunity 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 two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IDHIFA 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 IDHIFA

Therapeutically active compounds and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutically active compounds and their methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

NEW CHEMICAL ENTITY
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
Celgene Corp IDHIFA enasidenib mesylate TABLET;ORAL 209606-001 Aug 1, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Celgene Corp IDHIFA enasidenib mesylate TABLET;ORAL 209606-001 Aug 1, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene Corp IDHIFA enasidenib mesylate TABLET;ORAL 209606-001 Aug 1, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene Corp IDHIFA enasidenib mesylate TABLET;ORAL 209606-002 Aug 1, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celgene Corp IDHIFA enasidenib mesylate TABLET;ORAL 209606-001 Aug 1, 2017 RX Yes No 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 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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 13207289
Estimated Expiration: See Plans and Pricing

Patent: 17265096
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014016805
Estimated Expiration: See Plans and Pricing

Canada

Patent: 60623
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14001793
Estimated Expiration: See Plans and Pricing

China

Patent: 4114543
Estimated Expiration: See Plans and Pricing

Patent: 7417667
Estimated Expiration: See Plans and Pricing

Patent: 8912066
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 30962
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140377
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180844
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20506
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 00743
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 14012726
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0187
Estimated Expiration: See Plans and Pricing

Patent: 1491330
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 00743
Estimated Expiration: See Plans and Pricing

Patent: 06608
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 03942
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 38403
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3503
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09081
Estimated Expiration: See Plans and Pricing

Patent: 11895
Estimated Expiration: See Plans and Pricing

Patent: 15503571
Estimated Expiration: See Plans and Pricing

Patent: 17075193
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 00743
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 8940
Estimated Expiration: See Plans and Pricing

Patent: 14008350
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7096
Estimated Expiration: See Plans and Pricing

Patent: 2582
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1400073
Estimated Expiration: See Plans and Pricing

Norway

Patent: 97546
Estimated Expiration: See Plans and Pricing

Peru

Patent: 142098
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014501561
Estimated Expiration: See Plans and Pricing

Poland

Patent: 00743
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 00743
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 401
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201602862R
Estimated Expiration: See Plans and Pricing

Patent: 201403878Q
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 00743
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1405163
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1893112
Estimated Expiration: See Plans and Pricing

Patent: 140113712
Estimated Expiration: See Plans and Pricing

Spain

Patent: 75760
Estimated Expiration: See Plans and Pricing

Patent: 01430
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 53228
Estimated Expiration: See Plans and Pricing

Patent: 1329054
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1809228
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 7451
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 IDHIFA around the world.

Country Patent Number Title Estimated Expiration
Japan 2015503571 治療活性化合物およびその使用方法 See Plans and Pricing
Poland 2800743 See Plans and Pricing
Australia 2010223919 Methods and compositions for cell-proliferation-related disorders See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013102431 See Plans and Pricing
China 110386922 治疗活性化合物及其使用方法 (Therapeutically active compounds and their methods of use) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Merck
Moodys
Harvard Business School
Express Scripts

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.