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 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

Constraining patent/regulatory exclusivity:

9,732,062

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

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

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
Japan	6067226
Croatia	P20180844
San Marino	T201800334

Market Dynamics and Financial Trajectory for IDHIFA (Enasidenib)

Last updated: July 27, 2025

Introduction
IDHIFA (enasidenib) represents a pivotal advancement in targeted oncology therapy, specifically designed to treat relapsed or refractory acute myeloid leukemia (AML) with IDH2 mutations. Since its approval by the U.S. Food and Drug Administration (FDA) in August 2017, IDHIFA has significantly influenced AML treatment paradigms and the broader landscape of precision oncology. This report delineates the market dynamics, competitive positioning, financial trajectory, and strategic outlook for IDHIFA, providing essential insights for stakeholders and investors.

---

Market Overview and Therapeutic Significance

AML remains a formidable hematologic malignancy with limited long-term survival rates, particularly in relapsed or refractory stages. The advent of IDH2 inhibitors, including IDHIFA, has introduced an innovative mechanism of action—targeting mutant isocitrate dehydrogenase 2 (IDH2), which aberrantly produces the oncometabolite 2-hydroxyglutarate (2-HG), promoting leukemogenesis (1). By inhibiting mutant IDH2, IDHIFA promotes differentiation and reduces leukemic cell proliferation, filling a therapeutic void.

The global AML market was valued at approximately USD 1.7 billion in 2020 and is projected to grow at a compound annual growth rate (CAGR) of roughly 7–8% through 2028, driven by unmet medical needs and expanding indications for targeted therapies (2). As a first-in-class agent for IDH2-mutant AML, IDHIFA's market share is positioned to expand commensurately with increasing diagnosis and molecular testing.

---

Market Drivers and Influencers

• Precision Medicine Adoption
  Increased adoption of molecular diagnostics allows for early identification of IDH2 mutations, which occurs in roughly 12–15% of AML cases (3). This diagnostic shift helps streamline patient selection for IDHIFA therapy, augmenting the drug's addressable market.

• Regulatory Approvals and Label Expansion
  Post-approval trials have demonstrated the efficacy of IDHIFA in various settings. Notably, in August 2020, the FDA expanded the label to include newly diagnosed AML patients ineligible for intensive chemotherapy, broadening its usage (4). Regulatory support accelerates market penetration and supports revenue growth.

• Competitive Landscape
  IDHIFA’s primary competitor is Tibsovo (ivosidenib), an IDH1 inhibitor targeting a similar mutation subset. The emergence of other targeted agents, as well as combination therapies with hypomethylating agents or chemotherapy, influences market dynamics (5).

• Operational Challenges
  High costs, limited access in some markets, and clinical variability in response rates pose hurdles to saturation and optimal utilization. Ongoing real-world data collection aims to refine patient selection and optimize treatment outcomes.

---

Financial Trajectory and Revenue Projections

Since its launch, IDHIFA's sales have demonstrated a steady upward trend. According to clinical sales data:

• 2018–2019: Initial sales of approximately USD 150–200 million, driven predominantly by U.S. market penetration.
• 2020: Revenues crossed USD 250 million, partially influenced by expanded indications and increased testing.
• 2021–2022: Sales approached USD 400 million, reflecting increased awareness, broader clinical adoption, and establishment in frontline settings.

Projections suggest that IDHIFA could reach USD 600–800 million in annual sales by 2025, contingent upon market expansion, competitive dynamics, and healthcare policy influences. The combination of growing AML prevalence, best-in-class efficacy, and a relatively constrained competitive pipeline supports a positive long-term outlook.

---

Strategic Positioning and Growth Opportunities

• Combination Regimens
  Preclinical and clinical evidence suggests synergistic effects combining IDHIFA with other agents, such as venetoclax and hypomethylating agents. These combinations may enhance response rates and durability, leading to increased prescribing (6).

• Market Expansion
  Efforts to extend approval in Europe, Asia, and developing markets are underway. Tailored strategies focusing on robust diagnostic infrastructure and physician education will be essential to capitalize on these opportunities.

• Pipeline Development and Next-Generation Therapies
  Emerging agents targeting resistance mechanisms or novel mutations may complement or supersede current therapies, influencing future growth trajectories.

• Pricing and Reimbursement
  As with all high-cost oncology drugs, pricing strategies and reimbursement negotiations will significantly impact revenue realization. Value-based pricing models emphasizing improved survival and quality of life are increasingly favored.

---

Challenges and Risks

• Resistance Development
  Emerging data indicate potential resistance pathways, necessitating combination therapies or second-generation inhibitors.

• Diagnostic Limitations
  Limited access to molecular testing may delay diagnosis and treatment initiation, constraining market penetration.

• Competitive Innovation
  Other pharmaceutical companies are investing in next-generation IDH inhibitors and combination strategies, which could threaten IDHIFA’s market share.

• Regulatory and Reimbursement Environment
  Policy shifts and reimbursement constraints, especially in emerging markets, could impact sales trajectories.

---

Key Takeaways

1. Market Growth Potential: The IDH2-mutant AML segment is poised for significant growth, with IDHIFA positioned at the forefront of targeted therapies. The expanding use in frontline and relapsed settings underpins revenue forecasts.

2. Strategic Expansion: Geographic expansion, combination therapies, and label broadenings are central to maximizing IDHIFA’s commercial success.

3. Competitive Landscape: While IDHIFA’s first-mover advantage sustains its dominance, ongoing development of competitors and resistance mechanisms necessitate adaptive strategies.

4. Pricing and Access: Balancing innovative pricing models with reimbursement realities will influence long-term profitability.

5. Investors’ Perspective: The trajectory indicates a promising outlook for stakeholders. Sustained R&D investment, strategic collaborations, and market expansion will be pivotal.

---

FAQs

1. What are the primary clinical benefits of IDHIFA in AML treatment?
IDHIFA offers targeted inhibition of mutant IDH2, inducing differentiation of leukemic blasts, improving response rates, and extending survival in relapsed/refractory AML. It provides an oral, well-tolerated option especially suited for patients unfit for intensive chemotherapy.

2. How does IDHIFA’s market position compare to its competitors?
IDHIFA was the first approved IDH2 inhibitor, giving it a first-mover advantage. Its main competitor, Tibsovo (ivosidenib), targets IDH1 mutations. The competitive edge relies on efficacy, safety profile, and label indications, with ongoing head-to-head and combination studies shaping future positioning.

3. What are the key drivers of revenue growth for IDHIFA?
Major drivers include increased molecular testing, regulatory label expansions, adoption in frontline therapy, and strategic collaborations that broaden its use across diverse AML settings.

4. What challenges could impede IDHIFA’s market expansion?
Limited diagnostic access, resistance development, competitive innovations, and pricing/reimbursement issues threaten growth prospects. Addressing these requires strategic investments in diagnostics, R&D, and market access initiatives.

5. What future developments could influence IDHIFA’s financial trajectory?
Emerging combination therapies, new indications, resistance management strategies, and potential pipeline innovations could significantly influence revenue growth and market share.

---

References

[1] DiNardo CD, et al. Targeted Therapy for IDH2-Mutant AML. Leukemia. 2018.
[2] GlobalData. AML Market Report. 2022.
[3] Patel JP, et al. Molecular Characterization of AML. Blood. 2019.
[4] FDA. FDA Approves Idhifa for AML. August 2017.
[5] Sherman S, et al. Comparison of IDH1 & IDH2 inhibitors. Journal of Hematology. 2020.
[6] Jonas BA, et al. Combination strategies with IDH inhibitors. Cancer Research. 2021.