List of Excipients in Branded Drug REVUFORJ

Revuforj Excipient Strategy and Commercial Opportunities for Revumenib

Last updated: August 28, 2026

Revuforj, the trade name for revumenib, is an oral menin inhibitor approved by the FDA for adults and children with relapsed or refractory acute leukemia with a KMT2A translocation. Its current commercial formulation is an immediate-release tablet in 110 mg and 160 mg strengths. The most credible excipient opportunities are pediatric administration, feeding-tube compatibility, dose-flexible oral delivery, improved stability, and differentiated formulations that preserve exposure while reducing pill burden.

The near-term commercial opportunity is concentrated in the KMT2A-rearranged acute leukemia market. Longer-term value depends on label expansion into newly diagnosed disease, NPM1-mutated acute myeloid leukemia, combination regimens, and pediatric use.

What is Revuforj and how is revumenib administered?

Revuforj contains revumenib, an oral small-molecule menin inhibitor developed by Syndax Pharmaceuticals. The FDA granted accelerated approval on November 15, 2024, for adults and pediatric patients at least 1 year old with relapsed or refractory acute leukemia involving a KMT2A translocation. The approval was based on response data from the AUGMENT-101 study.[1]

Product attribute	Revuforj status
Active ingredient	Revumenib
Brand	Revuforj
Sponsor	Syndax Pharmaceuticals
FDA application	NDA 218944
Dosage form	Immediate-release film-coated tablet
Strengths	110 mg and 160 mg
Administration	Orally every 12 hours
Approved population	Adults and children at least 1 year old
Disease setting	Relapsed or refractory acute leukemia
Biomarker	KMT2A translocation
FDA action	Accelerated approval
Key safety issue	QTc prolongation and differentiation syndrome

Revuforj is administered twice daily. The label permits administration with or without food, which reduces dependence on meal timing and makes the current product suitable for outpatient use.[2]

What excipients are used in Revuforj tablets?

The Revuforj tablet uses conventional immediate-release excipients. The formulation includes lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and FD&C Yellow No. 6.[2]

Excipient	Likely formulation function
Lactose monohydrate	Diluent and tablet mass
Microcrystalline cellulose	Diluent, compression aid, disintegration support
Crospovidone	Superdisintegrant
Povidone	Binder
Sodium lauryl sulfate	Wetting agent and dissolution aid
Colloidal silicon dioxide	Glidant and moisture-flow aid
Magnesium stearate	Lubricant
Hypromellose	Film-forming coating polymer
Titanium dioxide	Opacifier and color modifier
Triacetin	Plasticizer
FD&C Yellow No. 6	Tablet-colorant system

The product uses a standard high-volume oral-solid-dose architecture. That creates limited differentiation at the base tablet level, but it leaves room for commercial development around administration, dose flexibility, pediatric use, and lifecycle management.

What formulation opportunities exist for Revuforj?

The most attractive opportunity is a pediatric and administration-friendly formulation that complements, rather than immediately replaces, the marketed tablets.

Pediatric oral suspension or dispersible tablet

Revumenib is already approved for children at least 1 year old, but a 110 mg or 160 mg tablet may not be optimal for small children or patients with dysphagia. A low-dose oral suspension, powder for reconstitution, mini-tablet, orally disintegrating tablet, or dispersible tablet could provide:

• Weight-based dosing.
• Easier administration in children.
• More precise dose titration.
• Reduced need for tablet splitting.
• Potential use in patients receiving intensive inpatient leukemia treatment.

The principal technical challenge is maintaining dose uniformity and chemical stability at low concentrations. A liquid product also requires control of sedimentation, microbial growth, preservative compatibility, container adsorption, and compatibility with enteral feeding equipment.

Feeding-tube compatible formulation

A dispersible tablet or validated suspension could address patients who cannot swallow tablets. A tube-compatible product would need data for:

• Recovery through common polyurethane and silicone tubes.
• Adsorption to tubing.
• Sedimentation and resuspendability.
• Flush-volume requirements.
• Compatibility with common enteral nutrition products.
• Stability after preparation and during temporary storage.

This opportunity is commercially relevant because relapsed acute leukemia patients may have mucositis, neutropenia, gastrointestinal complications, or reduced ability to swallow solid medication.

Orally disintegrating tablet

An orally disintegrating tablet could improve administration without requiring a liquid product. The approach would need to manage revumenib’s dose load, taste, mechanical strength, moisture sensitivity, and disintegration time. Taste masking is a central issue because sodium lauryl sulfate and some binder systems may not sufficiently control bitterness.

Dose-flexible multiparticulate system

Multiparticulates or mini-tablets could support pediatric weight bands and allow more precise dose escalation or reduction. A multiparticulate system could also separate immediate-release and modified-release populations for clinical testing. The commercial value would increase if the formulation aligns with dose adjustments required for CYP3A interactions or QTc-related safety management.

How can excipients address revumenib’s pharmacokinetic risks?

Revumenib is metabolized through CYP3A pathways, and the FDA label includes dose-modification requirements for concomitant CYP3A inhibitors and inducers. Revumenib also has a QTc-prolongation warning.[2] Excipients cannot remove these risks, but formulation design can support predictable exposure.

A formulation program should prioritize:

1. Consistent dissolution across fed and fasted conditions.
2. Low batch-to-batch variability.
3. Robust exposure at the lower end of the therapeutic window.
4. Compatibility with dose reductions.
5. Avoidance of excipient systems that create pronounced food effects.
6. Stability under hospital and outpatient storage conditions.

A self-emulsifying or lipid-based system could improve solubility if dissolution limits exposure, but the commercial case is weaker unless clinical data show a meaningful pharmacokinetic benefit. A lipid formulation could introduce food-effect, capsule-size, excipient-tolerability, and manufacturing complexity.

A more practical strategy is to optimize particle size, wetting, granulation, and disintegration before adopting a high-complexity delivery platform. The marketed use of sodium lauryl sulfate indicates that wetting and dissolution were already relevant formulation considerations.

What patents protect Revuforj and its formulation?

Revuforj’s principal protection is expected to come from revumenib composition-of-matter claims, therapeutic-use claims, and formulation or solid-state claims. The FDA Orange Book and USPTO records are the controlling sources for current patent listings, expiration dates, and patent-term adjustments.[3,4]

Protection category	Commercial relevance
Composition of matter	Broadest protection against revumenib generics
KMT2A-directed method of treatment	Supports the approved biomarker-defined indication
NPM1-directed use claims	Could protect a future expansion
Combination-treatment claims	Could cover use with chemotherapy or other targeted agents
Solid-state or salt claims	May restrict alternative manufacturing routes
Tablet or oral-liquid claims	Could delay or limit formulation-specific competition
Pediatric formulation claims	Could create lifecycle protection after core claims weaken
Manufacturing-process claims	May raise route-of-synthesis and impurity-control barriers

A formulation patent is most commercially valuable when it protects a clinically meaningful attribute, such as pediatric dosing, improved stability, tube delivery, reduced variability, or a lower pill burden. A patent directed only to routine excipient selection is more vulnerable to obviousness and design-around arguments.

Orange Book status and Paragraph IV risk

Because Revuforj was approved recently, generic entry risk is initially dominated by the active-ingredient patent estate and regulatory exclusivity rather than by a near-term formulation challenge. A generic applicant could file an Abbreviated New Drug Application with a Paragraph IV certification against listed patents once the relevant filing window and patent records permit it.

Likely challenge targets include:

• Obviousness of the revumenib compound claims.
• Written-description or enablement issues for broad genus claims.
• Scope of KMT2A method claims.
• Validity of solid-state or polymorph claims.
• Non-infringement based on an alternative formulation or manufacturing route.

When does Revuforj lose exclusivity?

Revuforj has multiple exclusivity layers, but the precise generic-entry date depends on the final Orange Book patent listings, patent-term adjustment, any patent-term extension, pediatric exclusivity, and litigation outcomes.

Exclusivity layer	Expected commercial effect
Orphan-drug exclusivity	Seven years of protection for the approved orphan indication, subject to statutory exceptions
New chemical entity exclusivity	Potential five-year period if applicable
Accelerated approval	Does not itself create a separate exclusivity period
Patent protection	May extend beyond regulatory exclusivity
Pediatric exclusivity	Six-month extension only if awarded after completion of an FDA-requested pediatric program
Method-of-use protection	Can narrow, but may not block, non-infringing generic indications
Formulation patents	May protect specific presentations after broader patents expire

The orphan-drug period generally runs from the date of approval for the designated indication. The FDA approval date was November 15, 2024, placing the nominal seven-year orphan period in November 2031, subject to the statutory framework and any applicable exclusivity determinations.[1,5]

A generic could potentially enter earlier for a non-protected indication if it can obtain approval without infringing enforceable method-of-use patents and if other listed patents do not block approval. That scenario is less straightforward for a narrow oncology product because most commercial demand is concentrated in the biomarker-defined population.

What patent litigation or Paragraph IV challenges affect Revuforj?

No major public Paragraph IV litigation or generic settlement has been identified as a central commercial issue at the initial launch stage. The absence of a reported challenge does not eliminate future risk. Revumenib’s commercial profile will attract patent scrutiny if sales expand through additional indications.

Potential litigation pressure points include:

• Core compound validity.
• Scope of claims covering menin inhibition.
• KMT2A-rearranged leukemia treatment claims.
• Future NPM1-mutated leukemia claims.
• Combination claims involving venetoclax, hypomethylating agents, or chemotherapy.
• Formulation claims directed to pediatric and liquid dosage forms.

Settlement agreements would be commercially significant only if they establish an authorized-generic launch date, a licensed generic, or an indication carve-out. No such settlement should be assumed without a filed agreement or court record.

What licensing deals support Revuforj’s commercial strategy?

Syndax is the principal commercial sponsor associated with Revuforj. Publicly disclosed commercial value is therefore more closely tied to Syndax’s development and commercialization execution than to a broad multi-company licensing structure.

The most relevant potential partnering areas are:

• Regional commercialization outside the United States.
• Pediatric formulation development.
• Combination trials with chemotherapy or targeted agents.
• Companion diagnostic support for KMT2A and NPM1 populations.
• Manufacturing scale-up and alternate-source supply.
• Authorized generic or access partnerships after core exclusivity.

A licensing deal for a liquid or pediatric presentation could preserve control of the core product while monetizing a separate formulation asset. A regional deal would be more attractive in markets where diagnostic testing for KMT2A rearrangements is established and orphan-drug reimbursement is available.

How large is the commercial opportunity for Revuforj?

The initial addressable market is limited by the prevalence of relapsed or refractory KMT2A-rearranged acute leukemia. The opportunity expands substantially if revumenib receives approval in earlier treatment lines or in NPM1-mutated acute myeloid leukemia.

Commercial drivers include:

• High unmet need in genetically defined acute leukemia.
• Potential use as a bridge to hematopoietic stem-cell transplantation.
• Inpatient and outpatient treatment demand.
• Pediatric adoption supported by a convenient formulation.
• Combination use in broader acute myeloid leukemia populations.
• Longer treatment duration in responders.

Commercial constraints include:

• Biomarker testing requirements.
• QTc monitoring.
• Drug-drug interaction management.
• Differentiation syndrome monitoring.
• Limited eligible population in the initial label.
• Competition from other menin inhibitors and investigational agents.
• Reimbursement pressure for a rare-disease therapy.

Revenue exposure will depend more on label expansion and duration of therapy than on excipient-driven price differentiation. A new formulation is most likely to protect market share and expand use rather than independently create the main revenue stream.

How does Revuforj compare with competing menin inhibitors?

Revuforj entered a developing menin-inhibitor class. The primary competitive variables are clinical efficacy, safety, dosing convenience, biomarker coverage, combination data, and regulatory timing.

Competitive variable	Revuforj position
Approved menin inhibitor status	FDA-approved
Initial biomarker	KMT2A translocation
Dosage form	Immediate-release tablets
Pediatric label	Includes patients at least 1 year old
Key safety management	QTc and differentiation syndrome
Lifecycle opportunity	NPM1, earlier-line disease, combinations
Formulation gap	Liquid, dispersible, tube-compatible, and dose-flexible options

A competitor with a liquid formulation, lower pill burden, fewer CYP3A restrictions, or reduced QT liability could pressure Revuforj even without superior response rates. Formulation development is therefore a defensive commercial tool.

What manufacturing and IP barriers affect Revuforj?

The main manufacturing barriers are likely to involve high-potency active-pharmaceutical-ingredient handling, impurity control, reproducible tablet dissolution, and supply continuity for a rare-disease product.

Priority manufacturing strategies include:

• Dual sourcing of revumenib API.
• Control of polymorphism and particle-size distribution.
• Tight limits for genotoxic and process-related impurities.
• Scalable wet or dry granulation.
• Low-moisture packaging if stability requires it.
• Container-closure systems that protect tablets during hospital distribution.
• Validated pediatric compounding or reconstitution procedures.

For lifecycle products, the strongest IP position would combine composition-of-matter claims with clinically useful formulation claims and manufacturing claims that are difficult to design around.

Key Takeaways

• Revuforj is an immediate-release revumenib tablet in 110 mg and 160 mg strengths.
• Its excipient system is conventional and includes lactose, microcrystalline cellulose, crospovidone, povidone, sodium lauryl sulfate, colloidal silicon dioxide, and magnesium stearate.
• The strongest formulation opportunities are pediatric suspension, dispersible tablet, orally disintegrating tablet, and feeding-tube compatible delivery.
• FDA approval occurred on November 15, 2024, with orphan-drug protection potentially extending to November 2031 for the approved indication.
• Core composition-of-matter and method-of-use patents are likely to present the main generic barriers.
• Formulation patents will have the greatest value if they solve dose flexibility, stability, tube administration, or pediatric acceptability.
• Revenue expansion depends primarily on NPM1 disease, earlier-line treatment, combination therapy, and longer treatment duration.
• The initial commercial market is narrow but strategically valuable because revumenib addresses a genetically defined leukemia population with high unmet need.

FAQs

Can Revuforj tablets be crushed or dispersed for children?

The FDA label does not establish tablet crushing or dispersion as an approved alternative administration method. A sponsor-controlled dispersible or liquid presentation would provide stronger regulatory and commercial protection.

Does Revuforj have a pediatric formulation?

Revuforj is approved for children at least 1 year old, but the marketed presentation is a tablet. A pediatric liquid, mini-tablet, or dispersible formulation remains a clear lifecycle opportunity.

Can a generic company avoid Revuforj patents by using different excipients?

Potentially, but an alternative excipient system would not avoid valid composition-of-matter or applicable method-of-use claims. Excipients mainly provide a design-around path for formulation-specific patents.

Could Revuforj receive approval for NPM1-mutated acute myeloid leukemia?

NPM1-mutated disease is a major potential expansion area for menin inhibition. Approval would require FDA review of clinical efficacy, safety, dosing, and the applicable biomarker-defined population.

What is the most valuable excipient opportunity for Revuforj?

A stable, dose-flexible oral suspension or dispersible tablet is likely the highest-value opportunity because it addresses pediatric dosing, dysphagia, feeding-tube administration, and weight-based dose adjustment in a single product strategy.

References

1. U.S. Food and Drug Administration. (2024, November 15). FDA grants accelerated approval to revumenib for relapsed or refractory acute leukemia with a KMT2A translocation. https://www.fda.gov
2. U.S. Food and Drug Administration. (2024). Revuforj (revumenib) prescribing information. Syndax Pharmaceuticals.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
4. United States Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/
5. U.S. Food and Drug Administration. (n.d.). Orphan drug designations and approvals database. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/