Revumenib citrate - Generic Drug Details

What are the generic drug sources for revumenib citrate and what is the scope of freedom to operate?

Revumenib citrate is the generic ingredient in one branded drug marketed by Syndax and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Revumenib citrate has forty-one patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for revumenib citrate

International Patents:	41
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	revumenib citrate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for revumenib citrate

Constraining patent/regulatory exclusivity:

TREATMENT OF RELAPSED OR REFRACTORY MIXED-PHENOTYPE ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER.

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.

Pharmacology for revumenib citrate

Drug Class	Menin Inhibitor
Mechanism of Action	Menin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for revumenib citrate

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

US Patents and Regulatory Information for revumenib citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-002	Nov 15, 2024		RX	Yes	No			Y	Y
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-002	Nov 15, 2024		RX	Yes	No
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-002	Nov 15, 2024		RX	Yes	No
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-001	Nov 15, 2024		RX	Yes	No			Y	Y
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-003	Nov 15, 2024		RX	Yes	Yes
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-003	Nov 15, 2024		RX	Yes	Yes			Y	Y

International Patents for revumenib citrate

Country	Patent Number	Title	Estimated Expiration
Poland	3468966
Mexico	2023002982	INHIBIDORES DE LA INTERACCION DE MENINA-LEUCEMIA DE LINAJE MIXTO. (INHIBITORS OF THE MENIN-MLL INTERACTION.)
European Patent Office	3805215
South Africa	201900150	INHIBITORS OF THE MENIN-MLL INTERACTION
Australia	2024202700
Mexico	2023002982	INHIBIDORES DE LA INTERACCION DE MENINA-LEUCEMIA DE LINAJE MIXTO. (INHIBITORS OF THE MENIN-MLL INTERACTION.)

Market Dynamics and Financial Trajectory for Revumenib Citrate

Last updated: February 20, 2026

What is the current development status of Revumenib citrate?

Revumenib citrate is an oral selective inhibitor targeting menin-MLL interaction, primarily developed for acute myeloid leukemia (AML) with KMT2A rearrangements or NPM1 mutations. It is in late-stage clinical trials with pivotal data expected within 12 to 24 months. The drug has received Breakthrough Therapy Designation from the FDA, indicating a high unmet need and potential expedited review [1].

How does Revumenib citrate position within the AML treatment landscape?

AML treatments include chemotherapy, targeted therapies, and stem cell transplantation. The market for AML drugs was valued at approximately USD 1.9 billion in 2021 and projected to grow at 7% CAGR through 2027 [2].

Key competitors include:

• Venetoclax + Azacitidine: Approved for newly diagnosed AML in elderly or unfit patients.
• MIDOSTAURIN: An emerging menin inhibitor under phase 1/2 trials.
• SNDX-5613: Another menin inhibitor in late-stage trials.

Revumenib’s unique mechanism targeting menin-MLL interactions positions it as a potential second-generation targeted therapy, especially for genetically defined subpopulations resistant to current treatments.

What are the potential revenue trajectories?

Forecasts depend heavily on clinical outcomes, regulatory approvals, and competitive positioning:

Year	Estimated Market Penetration	Potential Sales (USD millions)
2024	Data readouts; limited launches	0 (early-stage)
2025	Regulatory filing; initial approvals	150–300
2026	Broader adoption; increased usage	500–800
2027	Expanded indications; second-line therapy	1,200–2,000

If Revumenib gains FDA approval by 2025 for relapsed/refractory AML with high unmet need, peak sales could reach USD 2 billion, contingent on market uptake, pricing, and reimbursement policies.

How do pricing and reimbursement impact financial outlook?

Pricing estimates for menin inhibitors are speculative but likely to be in the USD 10,000–30,000/month range per patient. The actual price depends on:

• Regulatory approval scope
• Competitive landscape
• Payer negotiations
• Indication-specific value propositions

Reimbursement success hinges on demonstrating significant clinical benefits over existing therapies, especially in resistant cases.

What regulatory and market access factors influence future performance?

Achieving accelerated approval with Phase 2 data accelerates market entry but entails post-marketing commitments. Reimbursement discussions with CMS and private payers will influence adoption rates.

Regulatory success is influenced by collaboration with FDA and EMA, especially to validate surrogate endpoints like minimal residual disease (MRD) negativity or durable remission rates.

How will competitive pressures and pipeline developments shape the market?

Multiple pipeline candidates challenge Revumenib’s market share:

• SNDX-5613 (Deciphera): In phase 3 trials.
• BX-795 (BEAM Therapeutics): Genetic-specific drugs.
• Other menin inhibitors: Several in early-phase studies.

Market dominance relies on clinical efficacy, safety profile, and regulatory timing. Delays or failures in clinical programs could shift market dynamics considerably.

What are the key investment considerations?

• Clinical hold or trial setbacks could depress valuation.
• Regulatory approval could trigger substantial stock appreciation.
• Partnerships and licensing agreements with big pharma might secure significant funding or distribution channels.
• Market adoption depends on physicians’ acceptance in the AML community.

Key Takeaways

• Revumenib citrate is in late-stage development with potential for rapid market entry upon regulatory approval.
• The total addressable market revolves around AML, with specific focus on genetically defined subtypes.
• Sharp growth projections hinge on clinical trial success, regulatory timing, and market access.
• Pricing strategies and reimbursement negotiations will significantly influence revenue potential.
• Competitive pipeline candidates present ongoing risks and opportunities within select niches.

FAQs

1. When is Revumenib citrate expected to receive FDA approval?
Approval timelines depend on pivotal trial outcomes; data readouts are anticipated within 12–24 months, with potential NDA submission shortly thereafter.

2. Which AML patient population will Revumenib target first?
Initially targeting relapsed/refractory AML with KMT2A rearrangements or NPM1 mutations, representing approximately 10–15% of AML cases.

3. What are the main safety concerns associated with menin inhibitors like Revumenib?
Early-phase data indicate manageable toxicity, primarily hematologic. Long-term safety data remain pending from ongoing trials.

4. How does Revumenib compare to existing AML therapies?
It offers a targeted mechanism for genetically defined AML subsets, which current therapies do not specifically address, potentially leading to higher response rates in resistant disease.

5. What licensing opportunities exist for Revumenib citrate?
Strategic partnerships with big pharma could expand global reach, accelerate clinical development in additional indications, and enhance commercialization capabilities.

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References

[1] U.S. Food and Drug Administration. (2022). Breakthrough Therapy Designation. Retrieved from https://www.fda.gov
[2] MarketWatch. (2022). AML Treatment Market Size and Forecast. Retrieved from https://www.marketwatch.com