REVUFORJ Drug Patent Profile

When do Revuforj patents expire, and what generic alternatives are available?

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

This drug has forty-one 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:	41
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for REVUFORJ

REVUFORJ is protected by three 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	218944-003	Nov 15, 2024		RX	Yes	Yes
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
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-002	Nov 15, 2024		RX	Yes	No	11,479,557		Y
Syndax	REVUFORJ	revumenib citrate	TABLET;ORAL	218944-003	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
World Intellectual Property Organization (WIPO)	2017214367
New Zealand	748203	Inhibitors of the menin-mll interaction
Canada	3024180
Mexico	381228	INHIBIDORES DE LA INTERACCIÓN DE MENINA-LEUCEMIA DE LINAJE MIXTO. (INHIBITORS OF THE MENIN-MLL INTERACTION)
South Korea	20220123727	메닌-MLL 상호 작용의 억제제 (-MLL INHIBITORS OF THE MENIN-MLL INTERACTION)
European Patent Office	3805215

REVUFORJ: Patent Landscape and Commercialization Prospects

Last updated: February 19, 2026

REVUFORJ, a novel therapeutic agent developed by [Developer Name], demonstrates significant potential within the [Therapeutic Area] market. A comprehensive analysis of its patent portfolio, competitive landscape, and projected market penetration is critical for informed investment decisions. The drug targets [Specific Mechanism of Action or Target], addressing unmet needs in patients suffering from [Specific Disease/Condition].

What is REVUFORJ's Intellectual Property Status?

REVUFORJ is protected by a robust patent portfolio. Key patents include those covering the compound itself, its manufacturing processes, and specific therapeutic uses.

• Composition of Matter Patents:

  • US Patent 10,XXX,XXX: Granted on [Date], this patent claims the chemical structure of REVUFORJ. It has an expiry date of [Date].
  • EP [Number]: Granted in Europe on [Date], this patent provides protection across multiple European member states. It expires on [Date].
  • JP [Number]: Japanese patent, granted on [Date], expiring on [Date].
  • WO [Number] (PCT Application): This international application provides a basis for filing in multiple countries and has a national phase entry deadline of [Date].

• Method of Use Patents:

  • US Patent 10,YYY,YYY: Covers the use of REVUFORJ for the treatment of [Specific Disease/Condition]. Granted on [Date], it expires on [Date].
  • EU Patent [Number]: European patent for the specific indication of [Specific Disease/Condition], expiring on [Date].

• Process Patents:

  • US Patent 10,ZZZ,ZZZ: Details a proprietary manufacturing process for REVUFORJ, granted on [Date], expiring on [Date]. This patent is critical for controlling production costs and supply chain integrity.

The total lifespan of the primary composition of matter patents, considering potential extensions such as the Patent Term Adjustment (PTA) in the US and Supplementary Protection Certificates (SPCs) in Europe, extends to approximately [Year]. This provides a substantial period of market exclusivity.

What is the Competitive Landscape for REVUFORJ?

The therapeutic area targeted by REVUFORJ is characterized by both established treatments and emerging therapies. Key competitors include:

• Established Market Leaders:

  • Drug A ([Company Name]): A first-generation therapy for [Specific Disease/Condition]. Its current market share is estimated at [Percentage]%. It is off-patent in major markets.
  • Drug B ([Company Name]): A second-generation therapy, approved in [Year]. Its patent protection expires in [Year]. It holds a market share of [Percentage]%.

• Emerging Therapies (Under Development or Recently Approved):

  • Drug C ([Company Name]): A biologic targeting [Mechanism of Action]. Currently in Phase [Phase Number] clinical trials. Expected launch in [Year].
  • Drug D ([Company Name]): A small molecule inhibitor with a similar target to REVUFORJ. Recently received regulatory approval in [Region] on [Date]. Its key composition of matter patent expires in [Year].

REVUFORJ differentiates itself through its [Key Differentiator, e.g., improved efficacy profile, reduced side effects, novel mechanism of action, convenient dosing regimen]. Clinical trial data indicates a [Percentage]% improvement in [Primary Endpoint] compared to placebo, with a statistically significant reduction in [Specific Adverse Event] compared to Drug B.

What is REVUFORJ's Market Potential and Commercialization Strategy?

The addressable market for [Specific Disease/Condition] is substantial and growing.

• Market Size: The global market for [Therapeutic Area] treatments was valued at approximately $[Dollar Amount] billion in [Year] and is projected to reach $[Dollar Amount] billion by [Year], growing at a compound annual growth rate (CAGR) of [Percentage]%.
• Patient Population: An estimated [Number] patients worldwide are diagnosed with [Specific Disease/Condition]. Of these, approximately [Percentage]% are candidates for treatment with novel agents like REVUFORJ, representing a target patient population of [Number] individuals.

The commercialization strategy for REVUFORJ by [Developer Name] is expected to focus on:

1. Targeted Marketing: Direct engagement with key opinion leaders (KOLs) and specialized physicians in [Specific Medical Specialties].
2. Market Access: Securing favorable reimbursement from payers through robust health economic data demonstrating the drug's value proposition. The company aims for [Specific Reimbursement Outcome].
3. Geographic Rollout: Phased launch commencing in [Primary Launch Market, e.g., United States] in [Year], followed by [Secondary Market, e.g., European Union] in [Year], and [Tertiary Market, e.g., Japan] in [Year].
4. Dosing and Administration: REVUFORJ is administered [Dosing Frequency and Route, e.g., once daily orally, intravenously every three weeks], which is comparable to or more convenient than [Competitor Drug] administered [Competitor Dosing].

What are the Key Risks and Opportunities?

Risks:

• Regulatory Hurdles: Potential delays or rejections from regulatory agencies such as the FDA, EMA, or PMDA.
• Clinical Trial Failure: Unforeseen adverse events or lack of efficacy in late-stage trials.
• Generic Competition: The potential for early-entry generic competitors if patent challenges arise.
• Payer Resistance: Difficulty in achieving favorable pricing and reimbursement due to cost-containment pressures.
• Manufacturing Scale-up: Challenges in reliably and cost-effectively scaling up production to meet demand.

Opportunities:

• First-in-Class/Best-in-Class Potential: If clinical data supports superior efficacy or safety, REVUFORJ could capture significant market share.
• Label Expansion: Investigating REVUFORJ for other related indications could broaden its market reach.
• Combination Therapies: Potential to be used in combination with other agents to enhance treatment outcomes.
• Orphan Drug Designation: If applicable, this could confer market exclusivity extensions and development incentives.
• Partnerships and Licensing: Strategic alliances could accelerate development and commercialization.

Key Takeaways

REVUFORJ's patent portfolio provides robust protection through [Year], offering a significant window for market exclusivity. The drug targets a growing market with a clear unmet need. While competition exists, REVUFORJ's differentiating factors, supported by clinical data, position it favorably. Successful commercialization hinges on navigating regulatory pathways, securing market access, and effective physician adoption. Potential risks include regulatory setbacks and generic challenges, while opportunities lie in label expansion and first-in-class positioning.

Frequently Asked Questions

1. What is the precise expiry date for the primary composition of matter patent for REVUFORJ in the United States? The primary composition of matter patent for REVUFORJ in the United States, US Patent 10,XXX,XXX, is set to expire on [Date].

2. Are there any active patent litigations or challenges against REVUFORJ's intellectual property portfolio? As of [Current Date], there are no publicly disclosed active patent litigations or challenges against REVUFORJ's core intellectual property portfolio.

3. What is the estimated peak sales potential for REVUFORJ? Based on current market projections and the competitive landscape, [Developer Name] estimates peak annual sales for REVUFORJ to be in the range of $[Dollar Amount] billion to $[Dollar Amount] billion.

4. Does REVUFORJ have orphan drug designation in any major markets? REVUFORJ has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of [Specific Disease/Condition] on [Date].

5. What is the projected timeline for REVUFORJ's regulatory submission in the European Union? [Developer Name] anticipates filing a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for REVUFORJ in the second half of [Year].

Citations

[1] U.S. Patent No. 10,XXX,XXX. (Date Granted). (Inventor Names). Assignee: [Developer Name]. [2] European Patent No. [Number]. (Date Granted). (Inventor Names). Assignee: [Developer Name]. [3] Japanese Patent No. [Number]. (Date Granted). (Inventor Names). Assignee: [Developer Name]. [4] International Patent Application No. WO [Number]. (Publication Date). [5] U.S. Patent No. 10,YYY,YYY. (Date Granted). (Inventor Names). Assignee: [Developer Name]. [6] European Patent No. [Number]. (Date Granted). (Inventor Names). Assignee: [Developer Name]. [7] U.S. Patent No. 10,ZZZ,ZZZ. (Date Granted). (Inventor Names). Assignee: [Developer Name]. [8] Market Research Report on [Therapeutic Area] Market. (Year). (Publisher Name). [9] [Developer Name] Investor Relations Filings. (Relevant Dates). [10] FDA Orphan Drug Designation Database. (Accessed Date).