List of Excipients in Branded Drug HUMATIN

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Generic Drugs Containing HUMATIN

Company	Ingredient	NDC	Excipient
Woodward Pharma Services LLC	paromomycin sulfate	69784-510	D&C RED NO. 28
Woodward Pharma Services LLC	paromomycin sulfate	69784-510	D&C YELLOW NO. 10
Woodward Pharma Services LLC	paromomycin sulfate	69784-510	FD&C BLUE NO. 1

What are the Most Frequently-Used Excipients in HUMATIN?

# Of NDCs	Excipient
2	D&C RED NO. 28
2	D&C YELLOW NO. 10
2	FD&C BLUE NO. 1

Humatin Excipient Strategy and Commercial Opportunities for Paromomycin Sulfate

Last updated: September 24, 2026

Humatin is an oral paromomycin sulfate product used primarily for intestinal amebiasis. Its commercial value comes from a differentiated pharmacokinetic profile: paromomycin has limited gastrointestinal absorption, allowing high local intestinal exposure while reducing systemic aminoglycoside exposure compared with injectable agents.[1] The current capsule format has a simple excipient platform, but the product has opportunities in pediatric delivery, tropical-disease access, hospital supply continuity, and reformulated oral products.

The strongest near-term strategy is an immediate-release oral powder for suspension or sprinkle formulation that preserves local intestinal activity, improves administration for children and patients unable to swallow capsules, and remains compatible with an abbreviated FDA regulatory pathway. A low-complexity capsule generic is commercially feasible, but price competition and limited U.S. market size constrain returns.

What is Humatin and how does paromomycin sulfate work?

Humatin contains paromomycin sulfate, an aminoglycoside antibiotic administered orally for intestinal amebiasis caused by Entamoeba histolytica.[1] The labeled adult dose is generally 25 to 35 mg/kg/day, divided into three doses, for five to 10 days, subject to the prescribing information and clinical circumstances.[1]

Paromomycin is poorly absorbed from the gastrointestinal tract. Its principal therapeutic effect in intestinal amebiasis is therefore local intestinal activity rather than systemic exposure.[1] The same property creates a relatively clear excipient and dosage-form objective: excipients should support rapid release, dispersion, palatability, and dose accuracy without materially increasing absorption.

What are the main pharmaceutical characteristics?

Attribute	Commercial implication
Active ingredient	Paromomycin sulfate
Dosage form	Immediate-release oral capsule
Strength	250 mg capsule
Primary U.S. use	Intestinal amebiasis
Absorption	Limited gastrointestinal absorption
Main formulation target	Rapid local intestinal release
Core patient segments	Adults, pediatric patients, patients with dysphagia
Key formulation risks	Taste, powder handling, dose flexibility, moisture control
Main regulatory routes	ANDA for equivalent capsule; 505(b)(2) for a materially different dosage form

The product is not a conventional systemic oral antibiotic. A formulation that substantially changes dissolution, intestinal residence time, permeability, or microbiome exposure could create regulatory and clinical questions.

What excipients are used in Humatin capsules?

The Humatin capsule formulation uses a conventional hard-capsule excipient system. The FDA labeling identifies inactive ingredients including corn starch, magnesium stearate, and talc.[1] The capsule shell may contain colorants and other shell components that vary by manufacturing configuration and supplier.

Excipient function	Humatin capsule approach	Strategic assessment
Diluent or bulking support	Corn starch	Familiar, low-cost, compatible with immediate-release powder blends
Lubrication	Magnesium stearate	Effective at low levels; over-lubrication could slow wetting or dissolution
Glidant or processing aid	Talc	Supports powder handling; requires control of particle quality and supplier qualification
Shell	Hard gelatin capsule system	Established commercial format; less suitable for pediatric administration
Release profile	Immediate release	Appropriate for local intestinal activity

The existing excipient profile is commercially conservative. It avoids complex polymers, modified-release systems, and novel absorption enhancers. That is valuable for an ANDA-oriented strategy because the formulation can remain close to the reference product.

What excipient issues are most important for paromomycin sulfate?

Moisture and sulfate-salt stability

Paromomycin sulfate is supplied as a salt with a high molecular weight and strong ionic character. Moisture management should be assessed during blending, encapsulation, packaging, and storage. Water activity, hygroscopicity, capsule-shell moisture exchange, and dissolution after aging should be included in development work.

A high-barrier blister or bottle with a validated desiccant strategy may improve shelf life, particularly in tropical and high-humidity markets. Packaging selection is likely to have greater commercial value than adding a complex excipient system.

Blend uniformity and dose accuracy

The labeled capsule contains 250 mg of active ingredient, but pediatric dosing is weight-based. A powder with poor flow or segregation could create dose variability. Particle-size distribution, bulk density, electrostatic behavior, and blend uniformity should be controlled.

A formulation using pregelatinized starch, microcrystalline cellulose, or a comparable filler could improve manufacturing performance, but each substitution increases the need to demonstrate pharmaceutical equivalence to the reference product.

Lubrication and dissolution

Magnesium stearate is effective but can create wetting and dissolution problems when used at excessive concentration or with long blending times. Development should establish a narrow process window for lubricant level and blending duration. Comparative dissolution should be performed under multiple pH conditions because local intestinal release is central to the product’s therapeutic rationale.

Taste and mouthfeel

Paromomycin sulfate is likely to present a significant taste challenge if the capsule is opened or the active ingredient is dispersed in food or liquid. A pediatric product will need taste masking without creating an enteric or modified-release profile.

Potential approaches include:

• Polymer coating of paromomycin particles.
• Lipid or ion-exchange resin taste-masking systems.
• Multiparticulate granules administered in soft food.
• Flavored powder for suspension.
• A capsule-in-capsule or sprinkle configuration that limits oral contact.

Taste-masking excipients can materially affect dissolution and bioavailability. Any coated-particle system should be designed for rapid release after gastric or intestinal administration.

What formulations are protected by Humatin-related patents?

Humatin is an old drug product, and the principal commercial barriers are more likely to involve regulatory compliance, manufacturing know-how, supply reliability, and market access than broad composition-of-matter patent rights. Paromomycin itself is an established aminoglycoside antibiotic, so original compound patent protection is not a meaningful current barrier.

The FDA Orange Book should be reviewed for current patent listings and exclusivity associated with the relevant Humatin reference product.[2] For an established capsule product, the commercial diligence should focus on:

1. Current reference-listed drug status.
2. Active or expired patents listed for the capsule.
3. Approved generic applicants.
4. Product-specific labeling differences.
5. Whether the reference product is currently marketed.
6. Any discontinued-product or availability issues affecting ANDA selection.

A new pediatric suspension, sprinkle product, taste-masked granule, or stability-enhanced package could create patentable subject matter if the formulation provides a defined technical advantage. Potential claim categories include:

• Particle-size distributions.
• Coated paromomycin sulfate particles.
• Specific polymer or lipid coatings.
• Dry powder reconstitution systems.
• Preservative-free suspension systems.
• Moisture-protective packaging.
• Defined dissolution profiles.
• Combination of paromomycin with a taste-masking matrix.

A patent should not rely solely on the use of common excipients. The strongest claims would connect composition, process, performance, and clinical utility.

When does Humatin lose exclusivity?

Humatin’s original regulatory and patent exclusivity has long expired because paromomycin sulfate and the product have been marketed for decades. The relevant question is not the original loss of exclusivity but whether any current listed patents, regulatory exclusivity, or product-specific barriers remain for the reference-listed drug.

Exclusivity category	Current strategic relevance
Original compound patent	Expired
Original product patent	Expected to be expired for an old product
FDA new-drug exclusivity	Expired
Orphan-drug exclusivity	Not the principal barrier for intestinal amebiasis use
Pediatric exclusivity	No current commercial assumption should be made without an FDA record review
Current Orange Book patents	Must be checked against the active reference listing
Manufacturing know-how	Potentially relevant
Supply-chain barriers	Potentially material in a small market

The capsule market should therefore be assessed as a mature generic opportunity rather than an exclusivity-protected brand opportunity.

What is the Orange Book status of Humatin?

The FDA Orange Book is the controlling source for patent and exclusivity listings connected to approved reference products.[2] Humatin’s commercial assessment should distinguish between three conditions:

Active reference product

If Humatin remains the active reference-listed product, an applicant may pursue an ANDA referencing the capsule, subject to bioequivalence, quality, labeling, and manufacturing requirements.

Reference product with limited or uncertain marketing

If the brand is approved but has limited commercial availability, applicants may face sourcing, reference-standard, or market-availability issues. The FDA’s Drugs@FDA database, Orange Book, and product labeling should be reviewed together.[2,3]

Generic products already approved

Multiple approved generic capsule suppliers would reduce the attractiveness of a basic 250 mg capsule launch. Commercial differentiation would then depend on reliable supply, contract pricing, packaging, global tenders, or a differentiated pediatric dosage form.

Which companies are challenging Humatin with generic products?

A complete current list of ANDA holders and marketed suppliers requires a live FDA product and Orange Book review. The relevant competitive set includes manufacturers of paromomycin sulfate 250 mg capsules, contract manufacturers, and suppliers serving government or tropical-disease procurement channels.

The competitive assessment should rank companies by:

• FDA approval status.
• Current commercial availability.
• Annual manufacturing capacity.
• Drug shortage history.
• U.S. wholesaler coverage.
• Pediatric or non-U.S. dosage-form capability.
• Ability to supply low-income and humanitarian markets.
• API sourcing and sulfate-salt quality controls.

For a mature antibiotic with limited retail demand, supply continuity can be more important than brand recognition. A manufacturer that maintains dependable inventory may capture institutional accounts even without a novel formulation.

What Paragraph IV challenges and patent litigation affect Humatin?

No major current Paragraph IV litigation can be assumed solely from the age of Humatin. Paragraph IV risk depends on the active Orange Book listing at the time of ANDA filing. If no unexpired patents are listed, the principal filing issue would generally shift away from patent litigation and toward regulatory and commercial execution.

For a new formulation, litigation risk could arise from:

• Patents covering a reference product’s formulation.
• Patents covering a pediatric dosage form.
• Patents covering taste masking or multiparticulates.
• Patent claims directed to a particular method of treating amebiasis.
• Contract-manufacturing or supply agreements.

A formulation patent should be screened against earlier paromomycin, aminoglycoside, pediatric antibiotic, and oral suspension patents. Freedom-to-operate analysis should cover the United States, Europe, India, Brazil, and major public-procurement jurisdictions.

What excipient strategy offers the best commercial opportunity?

Option 1: Generic 250 mg immediate-release capsule

This is the lowest-risk route. The formulation can remain close to the reference product and use conventional excipients.

Commercial advantages include:

• Established dosage form.
• Straightforward patient instructions.
• Lower development cost.
• Potential ANDA pathway.
• Limited need for clinical differentiation.

Commercial disadvantages include:

• Small addressable market.
• Price competition.
• Limited pediatric utility.
• Low switching cost for institutional buyers.
• Potential dependence on one or two API suppliers.

Option 2: Pediatric oral powder for suspension

This is the strongest differentiated opportunity. A reconstitutable suspension could support weight-based dosing and improve access for children.

Key development requirements include:

• Taste masking.
• Uniform dose after shaking.
• Adequate in-use stability.
• Microbial control.
• Reconstitution instructions.
• Acceptable viscosity and pourability.
• Rapid release of paromomycin sulfate.
• Stability in hot and humid climates.

A preservative-free dry powder system may be attractive for global markets, although the packaging and reconstitution design must control microbial risk after water is added.

Option 3: Sprinkle granules or sachets

A sprinkle product could allow administration with soft food without requiring swallowing a capsule. This format may have better stability than a ready-to-use liquid and lower shipping weight than a bottle of suspension.

The formulation should prevent premature dissolution in the mouth while releasing promptly after ingestion. Sachet packaging could support unit dosing and reduce contamination during repeated use.

Option 4: Modified-release or enteric-coated product

This is a lower-priority strategy. Because paromomycin is intended to act in the intestinal tract and already has limited absorption, modified release may provide limited clinical value while increasing development complexity. An enteric system could be considered only if data show a meaningful benefit in local exposure, tolerability, or dosing convenience.

How strong is the commercial patent estate for Humatin?

The legacy patent estate is likely weak as a barrier to generic capsule entry because the active ingredient and product are old. The opportunity lies in building a new, narrow estate around delivery improvements.

Patent strategy	Expected strength
Paromomycin composition of matter	Low current value
Conventional 250 mg capsule	Low, unless a specific novel process is demonstrated
Pediatric taste-masked granules	Moderate to strong if technically distinct
Dry powder suspension	Moderate if stability and performance are superior
Moisture-protective packaging	Moderate, but design-around risk is high
New dosing regimen	Variable and vulnerable to validity challenges
Manufacturing process	Moderate if it solves impurity, uniformity, or stability problems

The strongest claim set would combine a defined composition with performance data, such as improved palatability, improved stability, controlled particle size, and equivalent or superior dissolution.

What generic launch risks exist for Humatin?

A generic capsule launch could face five primary risks:

1. Limited market size and slow inventory turnover.
2. API supply interruptions.
3. Difficulty obtaining dependable reference-product samples.
4. Reimbursement pressure and institutional tender pricing.
5. Low patient awareness and limited retail demand.

A pediatric product adds risks involving taste, dosing errors, preservative systems, and post-reconstitution stability. Those risks are manageable but should be addressed before selecting the commercial dosage form.

What manufacturing and IP barriers matter most?

The main manufacturing barriers are practical rather than fundamental:

• Consistent paromomycin sulfate particle properties.
• Uniform blending at commercial scale.
• Control of magnesium stearate lubrication.
• Capsule-fill weight variation.
• Moisture protection.
• Microbial quality for suspension products.
• Stable supply of pharmaceutical-grade API.
• Validated cleaning for antibiotic residues.

A manufacturer with established oral-solid-dose capacity could produce a capsule. A suspension or sprinkle product requires broader capabilities in particle engineering, coating, taste masking, packaging, and stability testing.

How does Humatin compare with competing anti-amebic products?

Product category	Primary site of action	Main commercial advantage	Main limitation
Paromomycin	Intestinal lumen	Poor systemic absorption; local activity	Capsule-based dosing and taste issues
Metronidazole	Systemic and tissue exposure	Broad availability and clinical familiarity	Systemic adverse effects and need for follow-on luminal therapy in some cases
Iodoquinol	Intestinal lumen	Established luminal therapy	Safety and tolerability considerations
Nitazoxanide	Intestinal and systemic exposure	Broad antiparasitic positioning	Different evidence and formulation profile
Diloxanide furoate	Intestinal lumen	Luminal amebicide use in some markets	Geographic availability varies

Paromomycin’s strongest differentiation is the combination of local intestinal activity and limited absorption. Its commercial weakness is dosage-form flexibility. An improved pediatric formulation could convert that weakness into a market advantage.

Key Takeaways

• Humatin contains paromomycin sulfate and is used mainly for intestinal amebiasis.
• The current capsule uses a conventional immediate-release excipient system based on corn starch, magnesium stearate, and talc.
• Original patent and regulatory exclusivity are no longer the main barriers to competition.
• A basic 250 mg capsule is the lowest-risk development route but likely has limited pricing power.
• A pediatric powder for suspension or sprinkle formulation offers the clearest commercial differentiation.
• Taste masking, moisture control, blend uniformity, and rapid intestinal release are the central formulation priorities.
• New patent value is more likely to arise from delivery technology, stability, packaging, or pediatric usability than from the active ingredient.
• FDA Orange Book and Drugs@FDA records should control the final assessment of current listings, ANDA competition, and regulatory status.[2,3]

FAQs

Is Humatin available as a liquid suspension?

Humatin is principally associated with the 250 mg oral capsule. A commercial paromomycin sulfate oral suspension would be a differentiated dosage form requiring formulation, stability, microbial-control, and regulatory development.

Can Humatin capsules be opened for children?

Opening capsules may be clinically considered when appropriate, but the contents may create taste and dose-uniformity problems. A purpose-built sprinkle or powder formulation would provide better control.

Is paromomycin sulfate absorbed into the bloodstream?

Paromomycin is poorly absorbed from the gastrointestinal tract. Absorption can increase when the intestinal mucosa is damaged, so the product label’s warnings and patient-selection considerations remain relevant.[1]

Does Humatin have biosimilar competition?

No. Humatin is a small-molecule antibiotic, not a biologic. The relevant competitors are generic drug products, not biosimilars.

Can a new Humatin formulation receive FDA exclusivity?

A new formulation may qualify for regulatory protection only if it meets the applicable statutory requirements. In practice, commercial protection would more commonly come from formulation patents, differentiated labeling, manufacturing know-how, or market access rather than from the legacy Humatin product.

References

1. U.S. Food and Drug Administration. (n.d.). Humatin (paromomycin sulfate) capsules prescribing information.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database.
4. World Health Organization. (2023). WHO guideline on the control and elimination of human schistosomiasis and soil-transmitted helminthiases. Geneva, Switzerland: World Health Organization.