IDHIFA Drug Patent Profile

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

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

See drug prices for IDHIFA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for IDHIFA

NDA:

209606

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

Sponsor	Phase
University of Chicago	Phase 1
University Health Network, Toronto	Phase 1/Phase 2
AbbVie	Phase 1/Phase 2

See all IDHIFA clinical trials

Pharmacology for IDHIFA

Drug Class	Isocitrate Dehydrogenase 2 Inhibitor
Mechanism of Action	Isocitrate Dehydrogenase 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for IDHIFA

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for IDHIFA

IDHIFA is protected by six US patents and two FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting IDHIFA

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			Y	Y
Celgene Corp	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No
Celgene Corp	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No
Celgene Corp	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes
Celgene Corp	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Nicaragua

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

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
Poland	2800743
Australia	2010223919	Methods and compositions for cell-proliferation-related disorders
World Intellectual Property Organization (WIPO)	2013102431
China	110386922	治疗活性化合物及其使用方法 (Therapeutically active compounds and their methods of use)