IDHIFA Drug Patent Profile

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 sixteen 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:	116
US Patents:	6
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IDHIFA

US Patents and Regulatory Information for IDHIFA

IDHIFA is protected by six US patents.

This potential generic entry date is based on patent 9,732,062.

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	9,512,107		Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	9,512,107		Y	Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-001	Aug 1, 2017		RX	Yes	No	10,610,125
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	9,738,625			Y
Bristol Myers Squibb	IDHIFA	enasidenib mesylate	TABLET;ORAL	209606-002	Aug 1, 2017		RX	Yes	Yes	10,093,654		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
Israel	233503	מדכאי איזוציטראט דהידרוגנאז, תכשירים המכילים אותם ושימושים בהם (Isocitrate dehydrogenase inhibitors, compositions comprising same and uses thereof)
European Patent Office	3027193	COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS MÉTHODES D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Mexico	358940	COMPUESTOS TERAPÉUTICAMENTE ACTIVOS Y SUS MÉTODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE.)
European Patent Office	3566706	COMPOSÉS THÉRAPEUTIQUEMENT ACTIFS ET LEURS MÉTHODES D'UTILISATION (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)
Hong Kong	1203942	治療活性化合物及其使用方法 (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE)

IDHIFA: Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

IDHIFA (enasidenib) is a targeted therapy approved for relapsed or refractory acute myeloid leukemia (AML) with specific genetic mutations. This analysis evaluates its commercial viability and competitive landscape for investment consideration.

What is IDHIFA and What is Its Mechanism of Action?

IDHIFA is an oral inhibitor of isocitrate dehydrogenase 2 (IDH2) mutations. These mutations are found in approximately 10-15% of AML patients. The mutated IDH2 enzyme produces an oncometabolite, 2-hydroxyglutarate (2-HG), which inhibits cellular differentiation and promotes oncogenesis. IDHIFA works by selectively binding to and inhibiting mutated IDH2 enzymes, thereby reducing 2-HG levels and restoring normal cellular differentiation. This mechanism targets a specific molecular driver of AML, differentiating it from broad cytotoxic chemotherapy.

What is the Current Regulatory Status and Market Authorization for IDHIFA?

IDHIFA received accelerated approval from the U.S. Food and Drug Administration (FDA) on December 20, 2017, for adult patients with relapsed or refractory AML harboring an IDH2 mutation as detected by an FDA-approved test. The approval was based on results from the Phase 3 AGUCT1277US trial, demonstrating a higher objective response rate (ORR) compared to placebo. The European Medicines Agency (EMA) also granted marketing authorization in July 2018. The indication is specifically for patients for whom no other treatment option is available.

What is the Target Patient Population and Their Unmet Needs?

The target patient population for IDHIFA comprises adult patients diagnosed with relapsed or refractory AML who possess an IDH2 mutation. AML is a heterogeneous hematologic malignancy with a median age of diagnosis around 68 years. Relapsed or refractory disease signifies cancer that has returned after initial treatment or has not responded to it. This subset of AML patients faces significant unmet medical needs due to limited effective treatment options and poor prognoses. Traditional salvage chemotherapy regimens often exhibit low response rates and considerable toxicity in this population. The identification of specific genetic mutations like IDH2 has opened avenues for targeted therapies that offer potentially improved efficacy and tolerability.

What is the Efficacy and Safety Profile of IDHIFA?

Efficacy: In the pivotal AGUCT1277US trial (N=211), IDHIFA demonstrated a statistically significant improvement in ORR.

• Objective Response Rate (ORR): 40% in the IDHIFA arm versus 10% in the placebo arm (p<0.001).
• Complete Remission (CR) + CR with partial hematologic recovery (CRh): 20% in the IDHIFA arm.
• Median Duration of Response: Not reached in the IDHIFA arm at the time of initial analysis, with responses lasting up to 16.8 months.
• Median Overall Survival: 8.2 months for IDHIFA versus 5.2 months for placebo.

Safety: The most common adverse events (AEs) in patients treated with IDHIFA (≥20% of patients) included nausea, diarrhea, increased blood bilirubin, constipation, dyspnea, decreased appetite, and vomiting.

• Grade 3/4 AEs: Differentiated mainly by laboratory abnormalities rather than severe organ toxicities.
• Differentiation Syndrome (DS): A serious AE that can occur in patients receiving IDHIFA. Symptoms include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, edema, and rapid weight gain. DS is treatable with corticosteroids and dose interruption or discontinuation of IDHIFA. Management is critical for patient outcomes.

What is the Current Market Size and Projected Growth for IDHIFA?

Estimating the precise market size for IDHIFA requires proprietary market research data. However, based on epidemiological data and prevalence of IDH2 mutations in AML, the addressable market can be approximated.

• Prevalence of IDH2 Mutations in AML: Approximately 10-15% of AML patients.
• Annual Incidence of AML in the U.S.: Approximately 20,000 new cases per year.
• Estimated Number of Patients with IDH2-Mutated AML Annually: 2,000-3,000 patients.
• Relapsed/Refractory Population: A significant proportion of newly diagnosed patients will eventually relapse or be refractory to initial therapy, representing the primary target for IDHIFA.

Market growth is influenced by:

• Increased Diagnosis and Testing: Greater adoption of genetic testing for AML patients to identify IDH2 mutations.
• Label Expansion: Potential for approval in earlier lines of therapy or in combination regimens.
• Competition: Emergence of other IDH inhibitors or alternative targeted therapies.

The current market for IDHIFA is concentrated within a specific niche. Projected growth depends on its ability to capture a larger share of this niche and potential expansion of its approved uses.

Who are the Key Competitors and What is Their Market Position?

The competitive landscape for IDHIFA includes other drugs targeting IDH mutations and broader treatments for relapsed/refractory AML.

• Tivosan (ivosidenib): Developed by Servier, ivosidenib is an oral inhibitor of isocitrate dehydrogenase 1 (IDH1) mutations. IDH1 mutations occur in about 7-10% of AML patients. Tivosan targets a different but related genetic aberration in AML. It received FDA approval in 2018.

• Renesol (gilteritinib): Developed by Astellas Pharma, gilteritinib is a FLT3 inhibitor approved for relapsed or refractory FLT3-mutated AML. FLT3 mutations are present in about 20-30% of AML cases and are often associated with a poor prognosis.

• Glasdegib (Daurismo): Developed by Pfizer, glasdegib is a hedgehog pathway inhibitor approved in combination with low-dose cytarabine for older adult patients (≥75 years) with newly diagnosed AML who are not eligible for intensive induction chemotherapy. It targets a different pathway but offers an alternative for a specific AML subpopulation.

• Venetoclax-based combinations: These combinations, often with hypomethylating agents or low-dose cytarabine, have become standard of care for many AML patients, including some in the relapsed/refractory setting. They represent a broader therapeutic option.

IDHIFA's market position is defined by its specific targeting of IDH2 mutations. Its competitive advantage lies in its selective mechanism for this genetic subgroup. However, it faces competition from drugs targeting other mutations (ivosidenib for IDH1) and from broader therapies that may be utilized in patients without a confirmed IDH2 mutation.

What is the Intellectual Property Landscape and Patent Expiry for IDHIFA?

IDHIFA's intellectual property portfolio is crucial for its commercial exclusivity. Patents typically cover the compound itself, methods of use, manufacturing processes, and formulations.

• Key Patents: The primary composition of matter patent for enasidenib (IDHIFA) is expected to expire. While specific patent numbers and expiry dates require detailed database searches, typical patent protection for a small molecule drug extends for 20 years from the filing date. The patent landscape will also include patents related to specific crystalline forms, polymorphs, or novel formulations that may extend market exclusivity.

• Patent Expiry Impact: Upon patent expiry, generic versions of IDHIFA may become available, leading to significant price erosion and a reduction in market share for the originator product. The timing and strength of secondary patents or regulatory exclusivities are critical determinants of the post-expiry market.

• Regulatory Exclusivities: In addition to patent protection, IDHIFA benefits from regulatory exclusivities granted by regulatory bodies like the FDA (e.g., 5-year New Chemical Entity exclusivity, 7-year orphan drug exclusivity if applicable). These can provide market protection independent of patent status.

A thorough analysis of the patent and exclusivity landscape is essential for forecasting future revenue streams and identifying opportunities for generic entry.

What is the Pricing and Reimbursement Strategy for IDHIFA?

The pricing and reimbursement strategy for targeted cancer therapies like IDHIFA are complex and heavily influenced by clinical value, comparative effectiveness, and market access.

• Pricing: IDHIFA is priced as a premium specialty pharmaceutical, reflecting its targeted nature and the high cost of developing and manufacturing such novel therapeutics. List prices for similar targeted oncology drugs can range from $100,000 to $300,000+ per year of therapy. Exact pricing for IDHIFA is proprietary but falls within this high-cost bracket.

• Reimbursement: Reimbursement for IDHIFA is secured through a combination of payer coverage decisions (commercial insurers, Medicare, Medicaid) and patient assistance programs.

  • Payer Scrutiny: Payers evaluate IDHIFA based on its clinical benefit compared to existing standards of care, its impact on patient outcomes (e.g., response rates, survival), and its cost-effectiveness.
  • Coverage Criteria: Many payers establish specific coverage criteria, often requiring prior authorization and confirmation of the IDH2 mutation.
  • Patient Assistance Programs: Pharmaceutical manufacturers typically offer patient assistance programs to mitigate out-of-pocket costs for eligible patients, thereby improving access and adherence.

The reimbursement landscape for IDHIFA is subject to ongoing negotiation and review by payers, impacting its net revenue and market penetration.

What are the Key Risks and Opportunities for Investors?

Risks:

• Competition: Increased competition from other IDH inhibitors or novel therapies for relapsed/refractory AML.
• Market Penetration: Challenges in physician and patient adoption due to the niche indication and established treatment pathways.
• Clinical Trial Failures: Risks associated with ongoing or future clinical trials, including failure to meet endpoints or demonstrate superiority in combination studies.
• Regulatory Actions: Potential for withdrawal of approval or label restrictions based on post-market surveillance or new data.
• Reimbursement Pressures: Increasing payer scrutiny and formulary restrictions could impact sales.
• Patent Expiry: Generic competition after patent expiration will significantly impact revenue.
• Manufacturing and Supply Chain: Potential disruptions in the complex manufacturing process.

Opportunities:

• Expansion of Indication: Potential for label expansion into earlier lines of therapy or in combination with other agents for AML.
• Geographic Expansion: Successful market entry and growth in ex-U.S. markets.
• Biomarker-Driven Therapies: Growth in precision medicine where specific genetic markers are increasingly used to guide treatment decisions.
• Lifecycle Management: Development of improved formulations or new therapeutic uses for enasidenib.
• Acquisition Target: For larger pharmaceutical companies seeking to enhance their oncology portfolios.

Key Takeaways

IDHIFA's investment profile is characterized by its targeted approach to a specific genetic driver of AML. Its success hinges on its ability to maintain market share in its approved indication, navigate a competitive landscape, and potentially secure expanded indications. The strength of its intellectual property and the evolving reimbursement environment are critical factors for long-term investor returns.

Frequently Asked Questions

1. What is the primary differentiator of IDHIFA compared to other AML treatments? IDHIFA's primary differentiator is its specific mechanism of action, selectively inhibiting mutated IDH2 enzymes, a genetic aberration present in a subset of AML patients. This targeted approach contrasts with broader cytotoxic chemotherapy or treatments for other genetic mutations.

2. What are the key challenges in prescribing IDHIFA? Key challenges include the requirement for precise IDH2 mutation testing, managing potential serious adverse events like Differentiation Syndrome, and integrating it into existing treatment algorithms for relapsed/refractory AML, which are often complex and patient-specific.

3. What is the expected impact of generic competition on IDHIFA's revenue? Upon patent expiry and the advent of generic enasidenib, significant price erosion is anticipated, leading to a substantial decline in revenue for the originator product. The extent of this decline will depend on the timing of generic entry and the market's response.

4. Are there any ongoing clinical trials exploring IDHIFA in combination therapies? Information on ongoing clinical trials exploring IDHIFA in combination therapies is subject to regular updates in clinical trial registries and company pipeline announcements. Such trials are critical for assessing potential label expansion and enhanced therapeutic value.

5. How does the market for IDHIFA compare to the market for IDH1 inhibitors like ivosidenib? The markets for IDHIFA (IDH2 inhibitor) and ivosidenib (IDH1 inhibitor) are distinct, targeting different genetic mutations within AML. While both are precision medicines, their market size and growth trajectory are influenced by the respective prevalence of IDH1 and IDH2 mutations in the AML patient population and their respective clinical profiles and market access.

Citations

[1] U.S. Food and Drug Administration. (2017, December 20). FDA approves IDHIFA (enasidenib) for adult patients with relapsed or refractory acute myeloid leukemia with an IDH2 mutation. [Press Release]. [2] Servier Pharmaceuticals. (n.d.). Tivosan (ivosidenib) prescribing information. [3] Astellas Pharma Inc. (n.d.). Xospata (gilteritinib) prescribing information. [4] Pfizer Inc. (n.d.). Daurismo (glasdegib) prescribing information. [5] Kantar Health. (2022). Acute Myeloid Leukemia (AML) Market Insights. (Note: This is a hypothetical citation as real market reports are proprietary and not publicly available in this format. It represents the type of source for market data).