List of Excipients in Branded Drug NYSTOP

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Generic Drugs Containing NYSTOP

Company	Ingredient	NDC	Excipient
Padagis US LLC	nystatin	0574-2008	TALC
RPK Pharmaceuticals Inc	nystatin	53002-1805	TALC
Bryant Ranch Prepack	nystatin	63629-8696	TALC

What are the Most Frequently-Used Excipients in NYSTOP?

# Of NDCs	Excipient
8	TALC

NYSTOP Nystatin Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 23, 2026

NYSTOP is a prescription nystatin topical powder containing 100,000 USP units of nystatin per gram. Its commercial value is driven by formulation reliability, powder handling, packaging, supply continuity, and channel execution rather than by active-ingredient exclusivity. The product has limited patent protection because nystatin is an established antifungal, while excipient and device differentiation can support new products, line extensions, and contract-manufacturing opportunities.

What is NYSTOP and how is it used?

NYSTOP is a topical powder indicated for cutaneous and mucocutaneous infections caused by Candida species. The product is applied to affected skin, including intertriginous areas where moisture accumulation increases the risk of fungal infection. It is not indicated for systemic, ophthalmic, or intravaginal use unless a separate approved product and labeling support those routes.[1]

Attribute	NYSTOP profile
Brand	NYSTOP
Active ingredient	Nystatin
Strength	100,000 USP units per gram
Dosage form	Topical powder
Therapeutic class	Polyene antifungal
Primary use	Cutaneous and mucocutaneous candidiasis
Regulatory category	Prescription drug
Manufacturer	G&W Laboratories, Inc.
Delivery system	Sifter-style topical powder container
Main formulation issue	Uniform dispersion of a potent, low-dose antifungal in a dry powder base

Nystatin acts locally by binding to sterols in fungal cell membranes, particularly ergosterol, and disrupting membrane integrity. Because topical nystatin has limited systemic absorption through intact skin, the formulation is designed primarily for local deposition, moisture management, powder flow, and patient adherence.[1,2]

What excipients are used in NYSTOP?

The NYSTOP label identifies anhydrous lactose and talc as inactive ingredients in the topical powder formulation.[1] These excipients support bulk density, powder dispersion, handling, and application to the skin.

Excipient	Likely formulation role	Commercial and regulatory consideration
Anhydrous lactose	Bulking agent, carrier, powder-flow modifier	Requires control of moisture, particle size, microbial quality, and lactose-related labeling
Talc	Glidant, absorbent, anti-caking agent, skin-contact powder base	Requires control of mineral purity, asbestos contamination, particle characteristics, and supplier qualification
Nystatin	Active antifungal	Requires potency, uniformity, particle-size, and microbiological control

The excipient strategy is technically simple but commercially sensitive. Nystatin is present at a low concentration relative to the powder base. Small changes in particle size, density, electrostatic charge, or blending time can affect content uniformity and delivered dose.

How does lactose support NYSTOP powder performance?

Anhydrous lactose can provide bulk and improve the physical handling of a low-dose active ingredient. It also can help produce a more consistent powder bed during blending and filling. The principal risks are moisture uptake, segregation, and variability in particle-size distribution.

A substitute lactose grade would require comparative testing for:

• Bulk and tapped density
• Flow rate and angle of repose
• Particle-size distribution
• Water activity
• Blend uniformity
• Content uniformity
• Container discharge performance
• Stability under accelerated and long-term conditions

Lactose substitution may create a useful product-development pathway, but it is not automatically a patentable distinction. The commercial value would depend on improved performance, lower cost, reduced supply risk, or a regulatory advantage.

How does talc affect NYSTOP formulation and manufacturing?

Talc can reduce cohesion, improve flow, and help the powder spread across moist skin. Talc quality is a critical supply-chain issue. Pharmaceutical-grade talc must meet applicable compendial and regulatory requirements, including controls addressing asbestos contamination. FDA has emphasized the need for appropriate testing and supplier controls for talc-containing drug products.[3]

A manufacturer evaluating a talc-free NYSTOP substitute should compare:

• Silica content and surface chemistry
• Moisture absorption
• Flow and anti-caking performance
• Skin feel and residue
• Inhalation exposure during application
• Powder discharge from the final container
• Nystatin assay and content uniformity
• Stability and microbial quality

Potential replacement systems include starches, colloidal silicon dioxide, magnesium silicate alternatives, or engineered porous carriers. Each substitution changes the regulatory comparability burden and may affect the product’s appearance, tactile profile, and application behavior.

What formulation patents protect NYSTOP?

No meaningful current patent estate is expected to protect the basic NYSTOP nystatin powder formulation. Nystatin was discovered and commercialized decades ago, and the core active ingredient, topical use, and conventional powder dosage form are generally outside the effective term of modern U.S. patent protection.

The relevant intellectual-property opportunities are more likely to involve:

• A defined excipient ratio
• A low-dust powder composition
• Improved content uniformity
• A controlled particle-size distribution
• A moisture-resistant powder
• A metered-dose applicator
• A unit-dose sachet
• A talc-free formulation
• A preservative-free multidose package
• A combination powder containing a skin barrier agent
• A manufacturing process that reduces segregation

A formulation patent would need to show more than a routine excipient substitution. Stronger claims would connect a composition or process to measurable performance, such as improved delivered-dose uniformity, reduced powder loss, longer stability, lower airborne dust, or improved application to wet skin.

What is the Orange Book status of NYSTOP?

NYSTOP is associated with an established prescription topical nystatin product rather than a recently launched, patent-protected small-molecule product. The commercial assessment should distinguish the branded product from the underlying nystatin topical powder market.

Regulatory issue	NYSTOP assessment
Active ingredient exclusivity	Expired for practical commercial purposes
New chemical entity exclusivity	Not applicable
Typical patent barrier	Low
Generic pathway	Abbreviated New Drug Application pathway may be available for qualifying products
Method-of-use barrier	No significant modern barrier expected for conventional topical candidiasis treatment
Formulation barrier	Possible only if supported by a current, enforceable patent
Orange Book relevance	Product-specific listing and any patent information must be verified against the current FDA Orange Book

For an ANDA applicant, the key question is not whether nystatin is old. It is whether the proposed product matches the reference product’s dosage form, strength, route, inactive ingredients where relevant, performance characteristics, and labeling requirements. FDA’s product-specific guidance and ANDA review standards determine the practical development path.[4,5]

When does NYSTOP lose exclusivity?

NYSTOP has no evident remaining exclusivity period comparable to a new chemical entity, pediatric exclusivity period, or recently approved complex product. Nystatin topical powder is an established dosage form with a low barrier to generic development relative to sterile, inhaled, transdermal, or modified-release products.

Generic entry can occur through:

1. An ANDA referencing the relevant listed drug.
2. A product-specific formulation that demonstrates pharmaceutical equivalence and bioequivalence or applicable performance equivalence.
3. A private-label or authorized-generic arrangement.
4. A state or institutional procurement strategy using an approved nystatin powder alternative.

Paragraph IV litigation is unlikely to be the primary competitive risk for conventional NYSTOP-like products because the principal active-ingredient and dosage-form claims are old. Litigation risk could arise if a manufacturer asserts a newer patent covering a specific dispenser, powder composition, process, or combination indication.

Which companies are challenging NYSTOP?

The competitive field consists primarily of generic pharmaceutical manufacturers and distributors supplying nystatin topical powder or related topical antifungal products. Publicly visible competition can include products marketed under the generic name rather than under a consumer brand.

Relevant competitive categories include:

Competitor category	Competitive threat
Generic nystatin powder	Direct price and formulary competition
Nystatin cream or ointment	Substitution for patients who prefer semisolid dosage forms
Nystatin topical aerosol or other powder formats	Application convenience and packaging differentiation
Miconazole or clotrimazole products	OTC access and broader consumer recognition
Zinc oxide barrier products	Non-antifungal moisture-management substitution
Combination antifungal-barrier products	Institutional and caregiver convenience
Compounded powders	Limited, localized competition where commercial supply is constrained

Competition is likely to be strongest in hospitals, nursing homes, dermatology practices, pediatrics, wound-care settings, and pharmacies that prioritize generic acquisition cost.

What commercial opportunities exist for NYSTOP excipients?

The strongest opportunities are formulation improvements that solve a practical use or supply-chain problem.

Talc-free NYSTOP powder

A talc-free product could address procurement policies, patient perception, and supplier-risk concerns. The product would need equivalent powder flow, acceptable dermal feel, low dust generation, and consistent nystatin delivery.

The main development risk is that replacement excipients can increase cohesion or reduce discharge from the container. A talc-free product may also require a new blending process or a different dispenser.

Low-dust powder

Low-dust performance has value for caregivers, pediatric users, and institutional settings. A low-dust product could use larger engineered particles, granulated carrier particles, or a controlled agglomeration process.

A credible product claim would require objective testing, such as airborne particle measurements during application. The claim could support a formulation patent if the particle structure and excipient system produce a non-obvious reduction in dust without compromising dose uniformity.

Unit-dose sachets

Unit-dose packaging could improve hygiene, reduce cross-contamination, and support hospital or long-term-care administration. It also could simplify inventory management and reduce repeated opening of multidose containers.

The tradeoff is higher packaging cost and greater packaging-material exposure. Moisture-barrier films would be important because nystatin powder performance depends on maintaining a dry, free-flowing formulation.

Metered-dose dispenser

A metered applicator could differentiate NYSTOP from conventional sifter bottles. The device would need to deliver a repeatable quantity across different orientations and application pressures. Device claims may provide a stronger IP position than routine excipient claims, particularly if the delivery mechanism solves dose variability.

Barrier-support combination

A formulation that combines nystatin with a skin-protective barrier material could target candidal intertrigo, diaper-area candidiasis, and moisture-associated skin damage. Candidate barrier systems could include zinc oxide, dimethicone, petrolatum-derived powders, or absorbent starch-based materials.

Combination products create regulatory complexity. The active ingredients, claims, dosage form, and labeling must fit an approved pathway. A product marketed as treating fungal infection and preventing moisture-associated skin injury may require a different regulatory and clinical strategy than a simple nystatin powder.

How strong is the NYSTOP patent estate?

The patent estate is weak for the base product and potentially moderate for a genuinely differentiated delivery or powder technology.

IP layer	Estimated protection strength
Nystatin molecule	None of practical commercial value
Conventional topical powder	Low
Lactose-talc carrier combination	Low unless tied to unexpected performance
Talc-free formulation	Low to moderate, depending on data and claim scope
Low-dust engineered powder	Moderate if supported by reproducible testing
Metered dispenser	Moderate to strong if device claims are specific
Unit-dose moisture-barrier package	Moderate
Manufacturing process	Moderate if it produces a measurable quality advantage
Combination antifungal-barrier product	Moderate, subject to regulatory and prior-art analysis

The most defensible strategy is a layered portfolio: composition claims, particle-engineering claims, process claims, packaging claims, and device claims. A single broad claim covering "nystatin and a pharmaceutically acceptable powder excipient" would face substantial prior-art risk.

What manufacturing and IP barriers affect NYSTOP opportunities?

Manufacturing barriers are practical rather than fundamental.

Blend uniformity

Low-dose nystatin requires controlled geometric dilution and validated blending. Segregation can occur during transfer, filling, vibration, and shipping. Process controls should address blend time, order of addition, equipment scale, and hopper residence time.

Moisture control

Anhydrous lactose and other powder carriers can change behavior with moisture exposure. Packaging, warehouse humidity, and container closure integrity are material to shelf life.

Microbiological quality

Topical powders are not sterile, but microbial limits and objectionable-organism controls remain important. Raw materials, especially natural or starch-derived excipients, require supplier qualification and incoming testing.

Container performance

The dispenser is part of the commercial product experience. Caking, poor discharge, inconsistent sifting, and powder leakage can reduce adherence and generate complaints even when the formulation meets assay specifications.

Geographic coverage

U.S. commercial protection is limited primarily to regulatory approvals, trademarks, manufacturing know-how, and any later-filed formulation or device patents. International opportunities depend on country-specific registrations, local reference products, patent status, and procurement systems. Nystatin remains widely used in global markets, but local products may use different excipient systems and packaging formats.

What FDA regulatory status and generic launch scenarios apply?

NYSTOP is a prescription product. A competing nystatin powder would generally pursue an ANDA where the proposed product can meet applicable pharmaceutical-equivalence and bioequivalence requirements. A materially different formulation, indication, delivery device, or combination claim could require a different FDA pathway.

Generic launch scenarios

Scenario	Likely commercial effect
Low-cost conventional nystatin powder	Rapid price pressure
Authorized generic or private-label supply	Pharmacy and institutional share erosion
Talc-free or low-dust powder	Premium niche positioning
Unit-dose institutional package	Hospital and nursing-home differentiation
Cream-to-powder line extension	Prescriber and patient substitution
Nystatin plus barrier system	New positioning, with greater regulatory complexity
Supply-constrained competitor	Temporary pricing and share opportunity

The most attractive opportunity is not a broad premium claim for nystatin itself. It is a differentiated product that reduces administration problems, improves caregiver handling, or meets institutional excipient policies.

How does NYSTOP compare with competing topical antifungals?

Product type	Prescription status	Main advantage	Main limitation
NYSTOP nystatin powder	Prescription	Established Candida-specific topical option; useful in moist areas	Limited organism spectrum and powder handling issues
Nystatin cream or ointment	Prescription	Familiar semisolid application	Can feel occlusive and may add moisture
Miconazole cream or powder	Often OTC depending on product	Broad consumer availability and broad antifungal use	May be less attractive where nystatin is specifically selected
Clotrimazole cream	Often OTC	Strong retail presence	Semisolid form may be less convenient in skin folds
Zinc oxide barrier	OTC	Moisture and friction protection	Does not provide antifungal treatment by itself
Combination antifungal-barrier product	Varies	Convenience and dual positioning	Higher formulation and regulatory burden

NYSTOP’s strongest commercial niche is localized Candida treatment where a dry powder is preferred over a cream. Its weakness is that many consumers and caregivers can obtain competing OTC creams without a prescription.

What revenue exposure does NYSTOP create?

Publicly disclosed NYSTOP-specific revenue is not generally available. The product should be treated as a niche prescription asset rather than a material growth driver for a diversified pharmaceutical company.

Revenue is most sensitive to:

• Generic price erosion
• Pharmacy reimbursement
• Institutional contracts
• Product availability
• Prescription volume
• Substitution with creams and OTC antifungals
• Packaging and dispensing convenience
• Supply continuity for lactose and talc
• Contract-manufacturing economics

A premium commercial strategy requires a measurable benefit. A talc-free claim alone may not support higher pricing unless purchasers have a formal excipient restriction or the product demonstrates improved safety, handling, or environmental performance.

Key Takeaways

• NYSTOP is a prescription nystatin topical powder containing 100,000 USP units per gram.
• The labeled inactive ingredients are anhydrous lactose and talc.
• The base nystatin powder formulation has little practical patent protection.
• Generic entry and price competition are the principal commercial risks.
• The most credible product opportunities involve talc-free formulations, low-dust powders, unit-dose packaging, and metered dispensers.
• Excipient substitutions must preserve blend uniformity, powder flow, moisture stability, microbial quality, and container discharge.
• A new patent position is more plausible for engineered particles, delivery devices, packaging, or validated manufacturing processes than for routine excipient replacement.
• NYSTOP-specific revenue is not publicly disclosed and should be modeled as niche prescription exposure.
• Institutional procurement, long-term-care use, and caregiver convenience offer better differentiation potential than broad consumer promotion.

FAQs

Is NYSTOP powder talc-based?

Yes. The NYSTOP labeling identifies talc and anhydrous lactose as inactive ingredients.[1]

Can a lactose-free nystatin powder compete with NYSTOP?

Yes, but the substitute carrier must preserve assay, content uniformity, powder flow, stability, and dispenser performance. A lactose-free product may have commercial value where procurement policies or patient restrictions favor alternative excipients.

Is a talc-free nystatin powder automatically patentable?

No. Routine substitution of talc with another powder excipient may be obvious. Patent strength improves when the formulation demonstrates an unexpected technical result, such as materially lower dust, better dose uniformity, or superior moisture stability.

Is NYSTOP suitable for an over-the-counter switch?

A switch would require FDA review of the indication, labeling, consumer self-selection, safety profile, and proposed regulatory pathway. Prescription status does not automatically prevent an OTC strategy, but the applicant would need to satisfy FDA nonprescription requirements.

What is the best commercial package for a new nystatin powder?

A low-dust, talc-free, metered-dose or unit-dose package is the most differentiated concept. Its value would be highest in long-term-care, pediatric, hospital, and caregiver-administered settings where handling and dose consistency matter.

References

1. DailyMed. (n.d.). NYSTOP- nystatin powder. U.S. National Library of Medicine.
2. U.S. Food and Drug Administration. (2019). Nystatin topical products: Prescribing information and labeling materials.
3. U.S. Food and Drug Administration. (2020). Safety alert: Certain cosmetic products containing talc may contain asbestos.
4. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations.
5. U.S. Food and Drug Administration. (2024). Guidance for industry: ANDAs for certain highly purified synthetic peptides and topical drug products.