ENASIDENIB MESYLATE - Generic Drug Details

What are the generic sources for enasidenib mesylate and what is the scope of patent protection?

Enasidenib mesylate is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Enasidenib mesylate has one hundred and fourteen patent family members in forty countries.

One supplier is listed for this compound.

Summary for ENASIDENIB MESYLATE

International Patents:	114
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENASIDENIB MESYLATE
What excipients (inactive ingredients) are in ENASIDENIB MESYLATE?	ENASIDENIB MESYLATE excipients list
DailyMed Link:	ENASIDENIB MESYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ENASIDENIB MESYLATE

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 ENASIDENIB MESYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Children's Oncology Group	Phase 2
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	Phase 1

See all ENASIDENIB MESYLATE clinical trials

Pharmacology for ENASIDENIB MESYLATE

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

Anatomical Therapeutic Chemical (ATC) Classes for ENASIDENIB MESYLATE

L01XM	Isocitrate dehydrogenase (IDH) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

US Patents and Regulatory Information for ENASIDENIB MESYLATE

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	209606-002	Aug 1, 2017		RX	Yes	Yes			Y	Y
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

International Patents for ENASIDENIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	030428	ТЕРАПЕВТИЧЕСКИ АКТИВНЫЕ СОЕДИНЕНИЯ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (THERAPEUTICALLY ACTIVE COMPOUNDS AND METHODS OF USE THEREOF)
Chile	2016000263	Compuestos terapéuticamente activos y sus métodos de uso.
Malaysia	185206	THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE
Chile	2017002240	Formas cristalinas del compuesto 2-metil-1-[(4-[6-(trifluorometil)piridin-2-il]-6-{[2-(trifluorometil)piridin-4-il]amino}-1,3,5-triazin-2-il)amino]propan-2-ol metanosulfonato; composición farmacéutica; usos en el tratamiento de neoplasias hematológicas avanzadas (divisional solicitud 263-2016).

Market Dynamics and Financial Trajectory for ENASIDENIB MESYLATE

Last updated: July 28, 2025

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Introduction

Enasidenib Mesylate, marketed under the developmental name IDHIFA®, is an oral, oral-targeted therapy developed by Celgene (a Bristol-Myers Squibb company) for the treatment of relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation. This drug has been a significant breakthrough in precision oncology, addressing a niche yet critical segment of hematologic malignancies. This article analyzes the evolving market dynamics and financial trajectory of Enasidenib Mesylate, examining factors influencing its commercial performance, competitive landscape, and future prospects.

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Market Dynamics

1. Unmet Medical Need and Market Opportunity

AML remains one of the most challenging hematological cancers, with a median survival of approximately 7-10 months in relapsed or refractory cases [1]. The identification of IDH2 mutations—present in roughly 12-14% of AML patients—created a targeted therapeutic opportunity. Enasidenib's approval by the FDA in August 2017 positioned it as a first-in-class agent specifically for IDH2-mutant AML, fulfilling a pressing unmet medical need.

The market for targeted therapies in AML is expanding, driven by advancements in genomic profiling, which enhances patient stratification. Enasidenib addresses this niche but significant segment, estimated at over 5,000 newly diagnosed cases annually in the U.S. alone, with global markets further expanding as diagnostic capabilities improve.

2. Competitive Landscape

While Enasidenib was the first approved IDH2 inhibitor, competitors have entered the market. Notably, Agios Pharmaceuticals developed Ivosidenib (atafluens), targeting IDH1 mutations. Though serving a different mutation subset, the presence of competing agents underscores the importance of efficacy, safety, and combination strategies in maintaining market share.

Other emerging therapies include combination chemo-immunotherapy regimens and new molecular inhibitors, which could challenge Enasidenib’s niche. Nonetheless, the drug's favorable safety profile and oral administration confer competitive advantages.

3. Regulatory and Reimbursement Environment

Regulatory approvals beyond the U.S., including Europe and Japan, are critical for global market expansion. Reimbursement depends on cost-effectiveness analyses showing superiority or non-inferiority to existing treatments. Given the high unmet medical needs and the drug's targeted nature, payers are relatively receptive, especially where biomarker-based diagnostics confirm appropriate patient selection.

4. Adoption and Prescribing Trends

Physicians’ adoption hinges on understanding the mutation status and integrating genomic testing into routine AML management. Clinical trial data demonstrate durable responses with Enasidenib, which influences clinician confidence and prescribing patterns. The drug’s ease of oral administration enhances adherence, critical in outpatient settings.

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Financial Trajectory

1. Revenue Growth and Market Penetration

Post-approval, Enasidenib reported rapid revenue accrual, with Bristol-Myers Squibb (BMS) detailing sales figures reaching approximately $250 million in 2021—markedly increasing from initial launches [2]. Rapid uptake was facilitated by unmet medical needs and the targeted therapy paradigm.

Key factors influencing revenues include:

• Patient access and diagnostics: Widespread use of Next-Generation Sequencing (NGS) tests to identify IDH2 mutations.
• Clinical efficacy: High response rates (around 40-50%) and durability influence clinician prescribing.
• Pricing strategies: Premium pricing aligned with targeted therapies, typically in the $150,000-$200,000 annual range in the U.S.

2. Cost of Development and Investment

Enasidenib's development involved significant R&D expenditure, typical for targeted oncology drugs, including preclinical studies, clinical trials, and regulatory approvals. The initial phase 1 and phase 2 trials cost tens of millions, with subsequent large-scale phase 3 studies further escalating costs.

Reimbursement and patent exclusivity offer revenue protection, but patent cliffs threaten future income streams. Patent protection for Enasidenib is expected to extend into the late 2020s or early 2030s, contingent on patent filings and regulatory data exclusivity.

3. Market Expansion and Variations

Beyond the U.S., growth depends on regulatory clearances. The European Medicines Agency granted conditional approval in 2018. The global AML market is projected to grow at a CAGR of 7-9% over the next five years, providing a fertile environment for Enasidenib’s sales.

Additionally, combination therapy studies with other agents (e.g., hypomethylating agents) suggest potential for label expansion, which could further augment revenue.

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Key Factors Shaping Future Financial Trends

• Evidence-Based Expansion: Ongoing trials evaluating Enasidenib in frontline and combination settings could broaden its use.
• Market Penetration Strategies: Enhanced diagnostic integration and education efforts should increase prescribing.
• Pricing and Reimbursement Policies: Negotiations with payers and health authorities can influence revenue potential.
• Patent and Market Exclusivity: Patent extensions or new formulations may protect revenue streams.

Challenges to Sustained Growth

• Emerging therapies and combination regimens may dilute market share.
• Competitive pressure from next-generation IDH inhibitors and alternative targeted therapies.
• Potential resistance mechanisms reducing long-term efficacy.

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Conclusion

Enasidenib Mesylate exemplifies successful targeted therapy innovation within oncology, with a promising financial trajectory driven by unmet needs, specific mutation targeting, and expanding indications. Its market growth will depend on clinical trial outcomes, regulatory approvals, competitive dynamics, and integration into standard AML treatment paradigms.

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Key Takeaways

• Enasidenib's success hinges on its targeted approach to IDH2-mutant AML, addressing a high unmet medical need.
• Rapid revenue growth since approval reflects strong clinical efficacy and market demand.
• Competitive landscape and emerging combination therapies present potential challenges.
• Global expansion and ongoing clinical trials could significantly enhance the drug's market share.
• Strategic patent protections and reimbursement negotiations are crucial for sustained revenue.

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FAQs

1. What is the primary mechanism of action of Enasidenib Mesylate?
Enasidenib inhibits the mutant IDH2 enzyme, reducing the production of the oncometabolite 2-hydroxyglutarate, thereby promoting differentiation and apoptosis of leukemia cells.

2. How does Enasidenib compare to other AML treatments?
It is a targeted oral therapy with a favorable safety profile, specifically effective in patients with IDH2 mutations, offering an alternative to conventional chemotherapies with less toxicity.

3. What are the main markets for Enasidenib?
The primary markets include the United States, Europe, and Japan, with potential expansion into other regions as approvals extend.

4. Are there any resistance concerns with Enasidenib?
Long-term use may encounter resistance mechanisms; ongoing research aims to identify combination strategies to mitigate resistance.

5. What is the outlook for Enasidenib’s market growth?
The outlook remains positive due to expanding indications, ongoing clinical trials, and increasing diagnostic testing, with expected sustained revenue growth over the next several years.

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References:

[1] Döhner, H., et al. (2017). Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood, 129(4), 424-447.
[2] Bristol-Myers Squibb. (2022). Enasidenib (IDHIFA®) sales reports. Company Financials.