Griseofulvin, microcrystalline - Generic Drug Details

What are the generic drug sources for griseofulvin, microcrystalline and what is the scope of freedom to operate?

Griseofulvin, microcrystalline is the generic ingredient in two branded drugs marketed by Wyeth Ayerst, Johnson And Johnson, J And J, and Valeant Luxembourg, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for griseofulvin, microcrystalline

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	96
DailyMed Link:	griseofulvin, microcrystalline at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for griseofulvin, microcrystalline

D01AA	Antibiotics
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

D01BA	Antifungals for systemic use
D01B	ANTIFUNGALS FOR SYSTEMIC USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for griseofulvin, microcrystalline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Luxembourg	GRIFULVIN V	griseofulvin, microcrystalline	TABLET;ORAL	062279-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Ayerst	GRISACTIN	griseofulvin, microcrystalline	CAPSULE;ORAL	050051-001	Approved Prior to Jan 1, 1982		DISCN	No	No
J And J	GRIFULVIN V	griseofulvin, microcrystalline	TABLET;ORAL	060618-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Johnson And Johnson	GRIFULVIN V	griseofulvin, microcrystalline	SUSPENSION;ORAL	050448-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
J And J	GRIFULVIN V	griseofulvin, microcrystalline	TABLET;ORAL	060618-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Griseofulvin Microcrystalline Market Dynamics, Financial Trajectory, and Patent Outlook

Last updated: September 5, 2026

Griseofulvin microcrystalline is a mature, low-revenue generic antifungal with no meaningful U.S. patent exclusivity. Its commercial position depends on low-cost manufacturing, product availability, pediatric dermatology demand, and the clinical trade-off between griseofulvin and newer oral antifungals such as terbinafine. Public sources do not disclose product-level revenue for griseofulvin microcrystalline, but the market profile indicates a stable-to-declining long-term revenue trajectory with periodic supply and pricing volatility.

What is griseofulvin microcrystalline and how is it used?

Griseofulvin microcrystalline, also called griseofulvin microsize, is an oral antifungal drug used against dermatophyte infections. It is available primarily as tablets and oral suspension. The drug is used for infections including tinea capitis, tinea corporis, tinea cruris, tinea pedis, and tinea unguium when systemic treatment is appropriate [1].

The microcrystalline formulation has smaller particles than conventional griseofulvin and improved dissolution characteristics. Absorption increases when the product is taken with a fatty meal. The formulation remains less soluble and less rapidly absorbed than ultramicrosize griseofulvin products, which use a separate particle-size technology [1].

Attribute	Griseofulvin microcrystalline
Active ingredient	Griseofulvin
Drug class	Oral antifungal
Dosage forms	Tablets, oral suspension
Common strengths	125 mg and 250 mg tablets; product-specific liquid concentrations
Primary indications	Dermatophyte infections
FDA status	Approved small-molecule prescription drug
U.S. patent position	No material active Orange Book patent protection identified
Regulatory exclusivity	No current new-drug exclusivity
Biosimilar exposure	None; griseofulvin is a small molecule
Commercial category	Mature generic and legacy branded product

How large is the griseofulvin microcrystalline market?

The U.S. market is a niche segment within oral antifungals. Product-level revenue is not separately reported by public companies or the FDA, and available market-research estimates generally aggregate griseofulvin with broader antifungal categories.

Demand is concentrated in several use cases:

• Pediatric tinea capitis, particularly when caused by Microsporum species.
• Dermatophyte infections where griseofulvin remains clinically suitable.
• Patients for whom terbinafine is less appropriate because of drug interactions, liver-risk considerations, organism sensitivity, or physician preference.
• Liquid formulations for children who cannot swallow tablets.

The product has a narrower commercial base than terbinafine. In many adult dermatophyte infections, physicians favor terbinafine because it can provide shorter treatment courses and has strong activity against Trichophyton species. Griseofulvin retains relevance in pediatric scalp ringworm and selected Microsporum infections, where treatment duration and organism susceptibility can favor griseofulvin [2].

What drives demand for griseofulvin?

The main demand drivers are epidemiological rather than innovation-based:

1. Incidence of tinea capitis and other dermatophyte infections.
2. Pediatric prescribing patterns.
3. Regional prevalence of Microsporum and Trichophyton species.
4. Availability of low-cost generic tablets and liquid products.
5. Insurance formulary placement and pharmacy substitution.
6. Prescriber response to resistance and treatment failure with alternative antifungals.

Demand is relatively price inelastic at the patient level but highly price sensitive at the payer and pharmacy level. Because multiple systemic antifungal alternatives exist, sustained price increases can shift prescribing toward terbinafine or itraconazole.

What is the financial trajectory for griseofulvin microcrystalline?

The financial trajectory is best characterized as mature, low-growth, and vulnerable to volume erosion. No public company reports a separately identifiable revenue line for griseofulvin microcrystalline. Brand-level sales, generic unit volumes, average selling prices, and manufacturer margins are generally confidential.

Financial factor	Expected effect
Generic competition	Reduces average selling price
Limited clinical innovation	Restricts premium pricing
Pediatric liquid demand	Supports a specialized, higher-value niche
Terbinafine substitution	Pressures volume
Few active manufacturers	Can increase shortage and pricing risk
Low manufacturing complexity	Limits long-term margin expansion
Hospital and retail purchasing	Increases price competition
Product discontinuations	May create temporary price spikes

The product’s revenue base likely follows a long-run declining or flat pattern rather than a growth trajectory. Volume can remain durable because griseofulvin is clinically established and inexpensive, but unit economics are constrained by generic substitution and the absence of patent protection.

A financially attractive opportunity is more likely to arise from supply consolidation, product restoration, or a differentiated liquid formulation than from broad market expansion. A manufacturer that maintains reliable supply during competitor exits can capture share without introducing a new mechanism of action.

When does griseofulvin microcrystalline lose exclusivity?

Griseofulvin microcrystalline lost meaningful U.S. exclusivity decades ago. The product is a legacy small molecule first commercialized in the mid-20th century. Its original active-ingredient and early formulation protections are no longer relevant to current market access.

The FDA’s Orange Book is the principal U.S. source for listed patents and regulatory exclusivity associated with approved drug products. Current griseofulvin microcrystalline products do not have the type of active patent estate associated with recently approved branded medicines [3].

Exclusivity category	Current position
New chemical entity exclusivity	Expired decades ago
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current material protection
New formulation exclusivity	No broadly recognized active protection for standard microsize tablets
Orange Book patent barrier	No material active barrier identified
Generic substitution	Established

What patents protect griseofulvin microcrystalline?

No material live patent protection appears to protect the core griseofulvin microcrystalline product in the United States. The relevant historical protections covered the active compound, formulations, particle-size approaches, and methods of treating fungal infections. Those rights have expired.

The commercial distinction between microcrystalline and ultramicrosize griseofulvin is primarily a product-development and manufacturing distinction, not a current patent moat. A manufacturer may still hold process, packaging, or private formulation know-how, but those rights would not generally block generic entry into standard microcrystalline tablets.

Are formulation patents a significant barrier?

Formulation patents are not a significant barrier for standard griseofulvin microcrystalline products. Potential areas of technical differentiation include:

• Particle-size distribution.
• Wetting and dissolution characteristics.
• Suspension stability.
• Taste masking.
• Excipient selection.
• Tablet disintegration.
• Packaging for liquid formulations.
• Fat-dependent absorption performance.

These attributes can affect product quality and physician or pharmacy preference. They are unlikely to support durable exclusivity unless a company develops a genuinely differentiated delivery system and obtains enforceable patent claims with meaningful remaining term.

What is the FDA regulatory status of griseofulvin microcrystalline?

Griseofulvin microcrystalline is an FDA-approved prescription drug. Generic versions can be approved through an abbreviated new drug application if they demonstrate pharmaceutical equivalence and bioequivalence to the relevant reference product [4].

FDA approval does not guarantee continuous commercial availability. Generic manufacturers can discontinue products, reduce production, or exit the market without creating a new regulatory event. This is important for griseofulvin because the market is old, low-margin, and dependent on a limited number of commercial suppliers.

What dosage forms are commercially important?

Tablets are the core dosage form. Oral suspension is strategically important because pediatric tinea capitis is a major use case and young patients may have difficulty swallowing tablets.

The liquid segment can have stronger pricing than standard tablets because it requires additional controls for:

• Suspension uniformity.
• Redispersibility.
• Palatability.
• Stability after opening.
• Dosing accuracy.
• Packaging and measuring devices.

These requirements create modest manufacturing and quality barriers but do not create the level of protection associated with a patented drug-delivery system.

Are there Paragraph IV challenges to griseofulvin microcrystalline?

Paragraph IV litigation is not a material current market issue for standard griseofulvin microcrystalline products. Paragraph IV challenges are most commercially important when a generic applicant seeks to enter before expiration of listed patents covering a branded product. Because the core griseofulvin microcrystalline market is already genericized and lacks a meaningful active Orange Book patent barrier, a major new Paragraph IV event is unlikely to determine market structure.

Potential disputes would more likely involve:

• Bioequivalence.
• Product quality.
• Labeling.
• Manufacturing controls.
• Trademark or trade-dress rights.
• Distribution and supply agreements.

What patent litigation affects griseofulvin microcrystalline?

No material active U.S. patent litigation is associated with the standard griseofulvin microcrystalline market in the principal FDA patent and approval records reviewed. Historical disputes involving griseofulvin do not create present exclusivity for ordinary microsize tablets or suspension products.

Litigation risk is therefore lower than for newer branded antifungals. The more realistic legal risks concern product liability, manufacturing deviations, regulatory enforcement, and commercial-contract disputes.

Which companies compete with griseofulvin microcrystalline?

Competition exists at three levels.

Direct griseofulvin competition

Direct competitors include generic manufacturers of griseofulvin microsize tablets and oral suspensions, as well as branded or legacy branded products such as Gris-PEG, although Gris-PEG is an ultramicrosize product rather than a microcrystalline equivalent [5].

The number of active suppliers can change as manufacturers discontinue low-volume products. This can produce temporary market concentration even when no patent protection exists.

Therapeutic competition

The principal alternatives are:

Drug	Competitive position
Terbinafine	Often preferred for many Trichophyton infections and shorter courses
Itraconazole	Used in selected dermatophyte infections and resistant cases
Fluconazole	Used selectively, depending on infection and local practice
Ketoconazole	Limited systemic use because of safety concerns
Topical antifungals	Relevant for superficial infections but inadequate for many scalp or nail infections

Terbinafine is the strongest commercial substitute. Its clinical advantages in selected infections reduce the addressable volume for griseofulvin, even though griseofulvin remains useful in pediatric scalp disease and certain organism profiles.

How strong is the patent estate for griseofulvin microcrystalline?

The patent estate is weak from an exclusivity perspective but adequate from a technical-manufacturing perspective.

Patent-estate factor	Assessment
Core compound protection	Expired
Standard microsize tablet protection	Expired or not commercially blocking
Standard oral suspension protection	No material current barrier identified
Method-of-use protection	Expired for legacy indications
Manufacturing know-how	May remain proprietary but generally nonblocking
Ability to prevent generic entry	Very low
Ability to support premium pricing	Very low

A company evaluating acquisition or licensing should value griseofulvin microcrystalline as a supply-chain and product-management asset, not as a patent asset.

What generic launch scenarios exist?

Three market scenarios are commercially realistic.

Stable multi-supplier market

Several manufacturers continue to supply tablets and suspension. Prices remain low, and revenue declines gradually with therapeutic substitution. This is the baseline scenario.

Supplier-exit consolidation

One or more manufacturers discontinue the product. Remaining suppliers gain volume and may obtain temporary pricing leverage. Revenue can rise for continuing suppliers even while total market demand remains flat or declines.

Formulation-led repositioning

A company launches a more convenient pediatric suspension, improved taste profile, or differentiated packaging. The product may gain share in children, but pricing power would depend on formulary access and whether the product receives meaningful regulatory or patent protection.

What manufacturing and intellectual-property barriers exist?

Manufacturing barriers are moderate for liquid products and low to moderate for tablets. The active ingredient is established, but production requires control of particle size, content uniformity, dissolution, and stability.

Key operational risks include:

• Active pharmaceutical ingredient supply concentration.
• Particle-size variation affecting dissolution.
• Suspension settling and dose nonuniformity.
• Low batch economics.
• Limited contract-manufacturing capacity.
• Product discontinuation by low-margin suppliers.
• FDA observations or manufacturing remediation.

The main competitive barrier is reliable supply, not intellectual property. A manufacturer with validated processes, established FDA compliance, and dependable distribution can compete effectively despite the absence of patent protection.

Does griseofulvin microcrystalline have biosimilar risk?

No. Griseofulvin is a conventional small-molecule drug. Biosimilar regulation applies to biological products, not to griseofulvin tablets or oral suspension. Competitive entry occurs through generic-drug pathways rather than abbreviated biologics applications.

What is the Orange Book status of griseofulvin microcrystalline?

The Orange Book does not provide a meaningful current patent barrier for standard griseofulvin microcrystalline products. The product category is best understood as an established generic market with approved reference products and generic equivalents, rather than as a branded product protected by listed patents [3].

The practical implications are:

• No patent-based delay to ordinary generic entry.
• No meaningful 30-month-stay litigation exposure tied to a live core patent.
• Limited value from patent due diligence.
• Greater importance of product-specific FDA approval status and commercial availability.

How does griseofulvin microcrystalline compare with terbinafine?

Factor	Griseofulvin microcrystalline	Terbinafine
Market maturity	Very mature	Mature generic
Typical treatment duration	Often longer	Often shorter
Pediatric scalp use	Strong historical role	Effective for many Trichophyton infections
Microsporum activity	Often clinically useful	May be less reliable
Patent leverage	None material	None material for standard generic tablets
Pricing power	Very low	Low
Liquid opportunity	Important	Less central
Commercial growth	Flat to declining	Stronger demand base

Griseofulvin is more exposed to clinical substitution than to patent expiry. The main competitive question is whether prescribers view the product as the preferred treatment for the infecting organism and patient population.

What licensing deals affect griseofulvin microcrystalline?

No major current licensing transaction is central to the U.S. griseofulvin microcrystalline market. The product is generally supplied through generic manufacturing, distribution, and private-label arrangements rather than high-value innovation partnerships.

Potential transaction value would arise from:

• Acquisition of an approved product portfolio.
• Transfer of an ANDA.
• Supply agreements.
• Access to an established pediatric liquid product.
• Manufacturing capacity or API sourcing.
• Distribution rights in underserved geographic markets.

A licensing deal based solely on griseofulvin patent rights would have limited economic rationale because the core patent estate is expired.

What geographic markets offer the strongest opportunity?

The most defensible commercial opportunities are in markets where:

• Tinea capitis incidence is high.
• Pediatric oral antifungal treatment is common.
• Generic supply is inconsistent.
• Local manufacturing is limited.
• Physicians continue to use griseofulvin for Microsporum infections.
• Oral suspension availability is poor.

The United States remains a low-value but regulated market. Emerging markets may offer higher volume, but pricing, reimbursement, local registration, tender competition, and counterfeit risk can offset that opportunity. Geographic expansion is more likely to produce volume growth than margin expansion.

Key Takeaways

• Griseofulvin microcrystalline is a mature generic oral antifungal with no meaningful current U.S. patent exclusivity.
• Public sources do not disclose standalone product revenue, but the financial trajectory is likely flat to declining.
• Pediatric tinea capitis and oral suspension demand provide the strongest commercial support.
• Terbinafine is the principal therapeutic competitor and limits long-term volume growth.
• Paragraph IV litigation and Orange Book patent risk are not material for standard microcrystalline products.
• Supply reliability, FDA compliance, liquid formulation quality, and distribution are more important than patent ownership.
• The best commercial opportunity is a low-cost, reliable supplier or a differentiated pediatric suspension, not a patent-led premium product.
• Biosimilar risk does not apply because griseofulvin is a small molecule.
• Geographic expansion may increase unit volume, but generic pricing and tender pressure will constrain profitability.

Frequently Asked Questions

Is griseofulvin microcrystalline still profitable?

It can be profitable for efficient manufacturers with reliable supply, but the product is unlikely to support high margins because of generic competition and limited pricing power.

Is griseofulvin microcrystalline being discontinued?

Discontinuation can occur at the manufacturer level, especially for low-volume products. Product availability should be assessed by specific dosage form, strength, manufacturer, and market.

Does griseofulvin microcrystalline have a generic equivalent?

Yes. Griseofulvin microcrystalline has long been available through generic prescription products, including tablets and oral suspension in relevant markets.

Which griseofulvin product has stronger commercial value, microsize or ultramicrosize?

Commercial value depends on supply, formulation, and clinical positioning. Ultramicrosize products may offer dosing and absorption advantages, while microcrystalline products benefit from established generic manufacturing and lower-cost positioning.

Can a new griseofulvin formulation obtain patent protection?

A new formulation may qualify for patent protection if it has novel, nonobvious, and adequately supported technical features. Standard particle-size, tablet, and suspension approaches are unlikely to create strong blocking protection without meaningful differentiation.

References

1. U.S. Food and Drug Administration. (n.d.). Griseofulvin microsize prescribing information. FDA Drugs@FDA database.

2. American Academy of Dermatology Association. (n.d.). Diagnosis and treatment of tinea capitis. https://www.aad.org

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov

4. U.S. Food and Drug Administration. (2024). Abbreviated new drug application (ANDA) process. https://www.fda.gov

5. U.S. Food and Drug Administration. (n.d.). Gris-PEG prescribing information. FDA Drugs@FDA database.