IDHIFA Drug Patent Profile

Which patents cover Idhifa, and what generic alternatives are available?

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 fourteen patent family members in forty 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:	114
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	12
Patent Applications:	860
Drug Prices:	Drug price information for IDHIFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IDHIFA
What excipients (inactive ingredients) are in IDHIFA?	IDHIFA excipients list
DailyMed Link:	IDHIFA at DailyMed

See drug prices for IDHIFA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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
AbbVie	Phase 1/Phase 2
University Health Network, Toronto	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

US Patents and Regulatory Information for IDHIFA

IDHIFA is protected by six US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes			Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes				Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes			Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No			Y	Y

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

Malaysia

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
Denmark	2800743
Japan	6742905
Japan	6409081
World Intellectual Property Organization (WIPO)	2015018060
Poland	2800743
Argentina	090411	COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO

Market Dynamics and Financial Trajectory for IDHIFA (Enasidenib)

Last updated: December 24, 2025

Executive Summary

IDHIFA (enasidenib) is an oral targeted therapy approved by the FDA in August 2017 for relapsed or refractory (R/R) acute myeloid leukemia (AML) with an IDH2 mutation. Over the past five years, its market trajectory has been shaped by evolving treatment paradigms in AML, competitive landscape shifts, regulatory updates, and expanding clinical applications. This analysis dissects current market dynamics, forecasted revenue streams, landscape competition, and strategic considerations impacting IDHIFA's financial trajectory.

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What is IDHIFA and Why Is It Significant?

IDHIFA is an inhibitor of mutant isocitrate dehydrogenase 2 (IDH2), which plays a pivotal role in abnormal cellular metabolism in AML. Its approval marked a key advance for personalized therapy in hematology, as it targets specific genetic subgroups, thus improving outcomes for a previously subcategory of AML patients.

• Indication: R/R AML with IDH2 mutation (FDA, 2017)
• Mechanism: Inhibits mutant IDH2 enzyme, promoting myeloid differentiation
• Market Impact: First targeted therapy approved for this subgroup, establishing a new treatment paradigm

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Market Size and Opportunity for IDHIFA

Global AML Market Overview (2022-2027)

Parameter	Value / Projection	Source
AML Global Market Size (2022)	$1.7 billion	[1]
Expected CAGR (2022-2027)	7-8%	[2]
AML Targeted Therapy Segment (2022)	$600 million	[3]
IDH2 Mutant AML Subset (approximate)	10-15% of AML patients (~18,000-25,000 globally)	[4], [5]

Note: The targeted segment's growth is driven by increasing genetic testing, improved diagnostics, and expanding indications.

Key Drivers

• Rising adoption of molecular diagnostics
• Expansion of companion diagnostics
• Increasing relapsed/refractory AML cases
• Growing awareness and treatment adoption in developed markets

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Current Market Dynamics

1. Regulatory and Clinical Development Landscape

• FDA Approvals & Labeling: Since its initial approval in 2017, IDHIFA’s label has expanded, including addition of trial data supporting use as front-line therapy in specific settings (e.g., newly diagnosed AML with IDH2 mutation).
• EMA & Global Approvals: Approved in EU (2018) and other markets, though timelines vary, influencing global market penetration.
• Ongoing Clinical Trials: Multiple Phase III studies are assessing IDHIFA as monotherapy and in combination, promising future indications.

2. Competitive Environment

Competitors	Key Products	Market Share (%)	Origin/Evidence	Status
IDHIFA (Enasidenib)	FDA-approved targeting mutant IDH2	~60%	Daiichi Sankyo, approved 2017	Monotherapy reliance
TIBSOVO (Ivosidenib)	IVDH1 inhibitor, AML & cholangiocarcinoma	~35%	Servier, approved 2018	Competes in similar subset
Others	Clinical-stage IDH2 inhibitors	Niche players	Multiple experimental agents	Future competition

Note: IDHIFA faces competition primarily from ivosidenib (TIBSOVO), which targets the IDH1 mutation and overlaps in treatment settings.

3. Pricing, Reimbursement, and Market Access

• Pricing (U.S.): Approximate wholesale acquisition cost (WAC) ~$19,050 per month (~$229,000 annually) (Daiichi Sankyo, 2022).
• Reimbursement: Coverage varies across healthcare systems, with favorable reimbursement in countries with established molecular testing policies.
• Cost-effectiveness: Demonstrated benefit in survival and response rates improves payer acceptance but challenges persist due to high costs.

4. Adoption and Prescribing Trends

Parameter	2022 Status	Comment
Prescriptions (U.S.)	~2,500 annually (estimated)	Growing, driven by combination therapy trends
Molecular Testing Adoption	>75% in developed countries	Facilitates targeted therapy initiation
Front-line Use	Limited but expanding in clinical trials	Expected to grow if approvals extend

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Financial Trajectory Forecast

1. Revenue Projections (2023–2028)

Year	Estimated Revenue	Growth Rate	Assumptions
2023	~$350 million	15%	Post-pandemic recovery, new indications
2024	~$405 million	15%	Continued market penetration, expanding use
2025	~$470 million	16%	Upfront approval for front-line AML
2026	~$550 million	17%	Increased combination therapy adoption
2027	~$640 million	16%	Broader global access

Assumptions: Gradual adoption in front-line settings, more approvals, sustained pricing, and competitive positioning.

2. Key Revenue Growth Drivers

• Expansion of Indications: Front-line AML therapy, combination regimens
• Geographical Expansion: Asia-Pacific, Latin America, MEA
• Clinical Data: Positive outcomes from ongoing trials (e.g., AGILE and other studies)

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Strategic Factors Influencing Market Dynamics

Factor	Impact on IDHIFA's Market Trajectory	Actionable Strategies
Increasing Use of Molecular Diagnostics	Facilitates early detection and targeted therapy adoption	Partner with diagnostics firms, promote testing guidelines
Competition and Patent Life	Patent expiry (expected 2033) could affect pricing and market share	Innovate via combination regimens, develop next-gen inhibitors
Pricing and Reimbursement Policies	Affects overall revenue and market access	Engage with payers early, demonstrate value through outcomes data
Clinical Trial Outcomes	Influence regulatory approvals and label expansion	Invest in trials for broader indications and combination therapies

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Comparison: IDHIFA vs. Competing Agents

Parameter	IDHIFA	TIBSOVO
Approval Year	2017	2018
Target	Mutant IDH2	Mutant IDH1
Indication	R/R AML, front-line (pending approval)	R/R AML
Pricing	~$229,000 annually	Similar (~$200,000–$240,000)
Market share (est.)	~60%	~35%
Unique Competitive Edge	Specific to IDH2 mutation	Broader mutation coverage (IDH1)

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Future Market and Clinical Outlook

• Emerging Combinations: Combining IDHIFA with hypomethylating agents (e.g., azacitidine) is under exploration, potentially expanding indications and improving efficacy.
• New Indications: Trials for other hematological malignancies (e.g., myelodysplastic syndromes) could further extend revenue streams.
• Biomarker Development: Enhanced diagnostics will improve patient selection and treatment response prediction.

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Key Takeaways

• IDHIFA remains a cornerstone in targeted AML therapy with significant growth prospects driven by expanding indications and improving diagnostic integration.
• Competition from ivosidenib and emerging agents pose challenges but also validate and expand the market for IDH mutation-targeted therapies.
• Reimbursement and pricing strategies are critical to sustained revenue, particularly as market penetration extends globally.
• Pipeline developments, including combination therapies and new indications, are poised to elevate IDHIFA's market position in the coming years.
• Strategic partnerships with diagnostics firms and investment in clinical trials will underpin long-term success.

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FAQs

1. What are the primary factors influencing IDHIFA’s market growth?

Market growth is driven by increased adoption of molecular diagnostics, expansion into front-line treatment, regulatory approvals for new indications, and ongoing clinical trials demonstrating efficacy.

2. How does IDHIFA compare to its main competitor, TIBSOVO?

IDHIFA targets IDH2 mutations, while TIBSOVO targets IDH1. IDHIFA holds approximately 60% of the market share in mutant IDH AML due to earlier approval and specific mutation targeting. Pricing, efficacy, and safety profiles are similar.

3. What are the major barriers to expanding IDHIFA’s market?

Barriers include high drug costs, limited reimbursement in some regions, competition from emerging therapies, and the need for comprehensive molecular testing infrastructure.

4. What future indications could expand IDHIFA's revenue?

Potential approvals include front-line AML, combination regimens with other targeted or chemotherapeutic agents, and applications in related hematological malignancies like MDS.

5. How are pricing and reimbursement policies influencing IDHIFA’s revenue?

High pricing necessitates demonstrating significant clinical benefit, while reimbursement status varies across markets. Favorable policies enhance adoption, especially when diagnostic and treatment value are communicated effectively.

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References

[1] Global Data, "AML Market Forecast," 2022.
[2] Research and Markets, "AML Therapeutic Market," 2023.
[3] EvaluatePharma, "Targeted Hematology Therapies," 2022.
[4] TCGA Research Network, "AML Molecular Profiling," 2021.
[5] American Cancer Society, "AML Incidence and Survival," 2022.