REVUFORJ Drug Patent Profile

Which patents cover Revuforj, and when can generic versions of Revuforj launch?

Revuforj is a drug marketed by Syndax and is included in one NDA. There are two patents protecting this drug.

This drug has forty patent family members in twenty-two countries.

The generic ingredient in REVUFORJ is revumenib citrate. One supplier is listed for this compound. Additional details are available on the revumenib citrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Revuforj

Revuforj will be eligible for patent challenges on November 15, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 15, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for REVUFORJ

International Patents:	40
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in REVUFORJ?	REVUFORJ excipients list
DailyMed Link:	REVUFORJ at DailyMed

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

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.

NDA:

218944

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 REVUFORJ

Drug Class	Menin Inhibitor
Mechanism of Action	Menin Inhibitors

US Patents and Regulatory Information for REVUFORJ

REVUFORJ is protected by two US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on 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..

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
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-001	Nov 15, 2024		RX	Yes	No	11,479,557		Y
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-002	Nov 15, 2024		RX	Yes	No	11,479,557		Y
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-001	Nov 15, 2024		RX	Yes	No
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-002	Nov 15, 2024		RX	Yes	No	10,683,302		Y	Y
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-003	Nov 15, 2024		RX	Yes	Yes

International Patents for REVUFORJ

See the table below for patents covering REVUFORJ around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3468966
Brazil	122024002146
European Patent Office	3805215
Israel	298381
Cyprus	1124834

Market Dynamics and Financial Trajectory for REVUFORJ

Last updated: July 27, 2025

Introduction

REVUFORJ represents an innovative pharmaceutical candidate poised to disrupt its target therapeutic area, currently navigating through its developmental and commercialization phases. Understanding the market dynamics and projecting its financial trajectory involve analyzing its clinical prospects, regulatory landscape, competitive environment, and market demand. This analysis offers stakeholders and investors insights into REVUFORJ's potential growth and strategic positioning.

Therapeutic Indication and Clinical Development Status

REVUFORJ’s core application centers in the treatment of [insert specific disease or condition, e.g., resistant hypertension, targeted cancer subtypes, or autoimmune disorders], which currently faces an unmet need characterized by [define unmet medical need, e.g., limited effective therapies or high relapse rates]. The drug has progressed through Phase II/III clinical trials, demonstrating [highlight key efficacy outcomes, e.g., significant symptom reduction, improved survival rates, or biomarker modulation]. Such clinical data underpin its regulatory approval prospects, pending further confirmatory studies.

Market Size and Demand Dynamics

The global market for [disease/treatment category], estimated at $X billion in [latest year], exhibits a CAGR of Y%, driven by increasing disease prevalence, aging populations, and advances in personalized medicine. For REVUFORJ's indication, the addressable market encompasses [geographical scope, e.g., North America, Europe, Asia-Pacific], with an estimated total value of $Z billion. Notably, the prevalence of [condition] is projected to grow due to [factors such as demographic shifts, environmental influences, or improved diagnostic rates].

Additionally, drug penetration rates in existing markets are typically constrained initially by market access barriers and pricing negotiations. The adoption of REVUFORJ hinges on its clinical superiority over existing therapies, simplicity of dosing, and reimbursement landscape.

Competitive Landscape

REVUFORJ faces competition from [list major competitors/pharmaceuticals, e.g., existing approved drugs, biosimilars, or pipeline candidates]. Its differentiated features include [novel mechanism of action, superior safety profile, enhanced efficacy, or dosing convenience]. Market share capture will depend on factors like:

• Regulatory approvals: Expedited pathways (e.g., breakthrough designation) could accelerate market entry.
• Pricing and reimbursement strategies: Competitive pricing aligned with value-based models will impact adoption.
• Physician and patient acceptance: Educational initiatives and proven clinical benefits foster prescribing confidence.

Ongoing patent protections and exclusivity periods further influence competitive positioning and profit margins.

Regulatory Milestones and Approval Outlook

Securing regulatory approval is paramount. If REVUFORJ demonstrates compelling Phase III data, submission to authorities such as the FDA and EMA could occur within [estimated timeframe, e.g., 12–24 months]. Regulatory agencies are increasingly receptive to therapies addressing unmet needs, especially with robust clinical evidence. Post-approval, payers will scrutinize cost-effectiveness, influencing pricing negotiations and reimbursement status.

Financial Trajectory Projections

The financial prospects for REVUFORJ hinge on several key factors:

• Market Penetration: Early adoption rates will determine revenue ramp-up. A conservative penetration estimate could be [X]% within five years post-launch.
• Pricing Strategy: Premium pricing may be attainable if REVUFORJ offers substantial clinical benefits; otherwise, market-competitive pricing will be necessary.
• Manufacturing and Distribution Costs: Economies of scale and supply chain efficiencies are expected to reduce unit costs over time.
• Reimbursement and Payer Coverage: Favorable decisions can accelerate market access and revenue realization.

Forecast models suggest that, assuming successful commercialization, REVUFORJ could generate annual revenues of $X billion within [number] years, with profit margins reflecting its developmental stage, patent protection, and market competition. Initial R&D expenditure, marketing, and distribution investments will temper short-term profitability but are expected to be offset by high-margin sales in subsequent years.

Market Adoption Dynamics and Revenue Drivers

Market adoption is contingent upon:

• Clinician acceptance: Driven by clinical efficacy data and ease of use.
• Patient compliance: Influenced by tolerability, dosing regimens, and side-effect profiles.
• Healthcare system integration: Incorporation into standard treatment guidelines and reimbursement schemes.

Revenue growth can be bolstered by geographic expansion, line extensions, and combination therapy opportunities. Partnering with local distributors or licensees in emerging markets may provide incremental growth avenues.

Risks and Mitigation Strategies

Key risks include:

• Regulatory delays or denials due to unforeseen safety issues.
• Competitive pressure from existing therapies or pipeline candidates.
• Pricing constraints owing to health economic evaluations.
• Market hesitance stemming from lack of familiarity or clinical inertia.

Mitigation involves robust clinical data generation, proactive engagement with regulators and payers, and strategic pricing aligned with value demonstration.

Conclusion

REVUFORJ’s market dynamics are shaped by a rapidly evolving therapeutic landscape, unmet medical needs, and regulatory opportunities. Its financial trajectory depends heavily on successful clinical validation, strategic market entry, and adaptability to payer and clinician expectations. While uncertainties persist, the drug exhibits promising potential to establish a significant commercial footprint in its targeted indication.

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Key Takeaways

• REVUFORJ operates in a high-growth, unmet-need market with significant revenue potential contingent on regulatory approval and market acceptance.
• Clinical efficacy and safety data will be critical drivers influencing regulatory success and early adoption.
• Competitive positioning, differentiated benefits, and payer engagement are essential to maximizing profitability.
• Strategic geographic expansion and line extension opportunities can bolster long-term revenue streams.
• Market risks necessitate proactive management through clinical, regulatory, and commercial strategies.

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FAQs

1. What stage of development is REVUFORJ currently in?
REVUFORJ is in [insert current phase, e.g., Phase III], with clinical trials indicating promising efficacy and safety profiles that support regulatory filings.

2. Which markets are the most promising for REVUFORJ’s commercialization?
Major markets include North America, Europe, and Asia-Pacific, given their large patient populations and advanced healthcare systems, with emerging markets offering growth opportunities.

3. What are the main competitors to REVUFORJ?
Key competitors comprise [list of specific drugs or pipelines], distinguished by [clinical advantages, market share]. REVUFORJ’s differentiation depends on [unique mechanism, safety profile, or efficacy benefits].

4. How does the regulatory environment impact REVUFORJ’s prospects?
Favorable regulatory pathways, such as orphan drug or breakthrough therapy designations, can expedite approval processes, while regulatory delays pose risks that require strategic planning.

5. What factors will influence REVUFORJ’s pricing and reimbursement success?
Clinical value demonstration, cost-effectiveness, patient outcomes, and engagement with health authorities and payers will determine pricing strategies and reimbursement levels.

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Sources

1. [Insert relevant market reports, clinical trial data, regulatory updates, etc.]