FULVICIN P/G Drug Patent Profile

Which patents cover Fulvicin P/g, and when can generic versions of Fulvicin P/g launch?

Fulvicin P/g is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in FULVICIN P/G is griseofulvin, ultramicrosize. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the griseofulvin, ultramicrosize profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fulvicin P/g

A generic version of FULVICIN P/G was approved as griseofulvin, ultramicrosize by MOUNTAIN on January 9^th, 2014.

Summary for FULVICIN P/G

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	76
Patent Applications:	4,486
DailyMed Link:	FULVICIN P/G at DailyMed

Pharmacology for FULVICIN P/G

Drug Class	Tubulin Inhibiting Agent
Physiological Effect	Decreased Mitosis Microtubule Inhibition

US Patents and Regulatory Information for FULVICIN P/G

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Chartwell Rx	FULVICIN P/G 330	griseofulvin, ultramicrosize	TABLET;ORAL	061996-004	Apr 6, 1982		RX	No	No
Chartwell Rx	FULVICIN P/G	griseofulvin, ultramicrosize	TABLET;ORAL	061996-002	Approved Prior to Jan 1, 1982	AB	RX	No	No

Fulvicin P/G Market Dynamics, Patent Status, FDA History, and Financial Trajectory

Last updated: August 18, 2026

Fulvicin P/G was an older oral formulation of griseofulvin, an antifungal used mainly for dermatophyte infections of the skin, hair, and nails. Its commercial trajectory is defined by generic substitution, low pricing, limited clinical differentiation, and eventual loss of branded-market relevance. The product is no longer a meaningful branded pharmaceutical asset, and no current standalone revenue disclosure is publicly available.

The key commercial facts are:

• Active ingredient: griseofulvin, microsize formulation.
• Historical brand: Fulvicin P/G.
• Therapeutic category: systemic antifungal.
• Primary indications: tinea infections, including tinea capitis, tinea corporis, tinea cruris, tinea pedis, and tinea unguium.
• Market position: legacy product replaced by generic griseofulvin microsize.
• Patent position: original product and composition protection are long expired.
• FDA position: historical approval; current commercial availability depends on generic manufacturers and wholesalers rather than the Fulvicin P/G brand.
• Financial profile: no separately reported current revenue; likely negligible branded revenue after generic erosion and product discontinuation.

What is Fulvicin P/G and how does it compare with other griseofulvin products?

Fulvicin P/G is associated with griseofulvin microsize, an oral antifungal derived from Penicillium species. Griseofulvin works by disrupting fungal mitosis and concentrates in newly formed keratin, making it useful against dermatophytes rather than Candida or most systemic molds.

The "P/G" designation historically distinguished the product from other griseofulvin formulations, particularly ultramicrosize products such as Fulvicin U/F and Gris-PEG. Microsize and ultramicrosize formulations differ in particle size, absorption characteristics, and typical dose requirements.

Product or formulation	Active ingredient	Commercial role	Typical market outcome
Fulvicin P/G	Griseofulvin microsize	Historical branded product	Superseded by generic microsize products
Fulvicin U/F	Griseofulvin ultramicrosize	Historical branded formulation	Lost relevance after generic competition
Gris-PEG	Griseofulvin ultramicrosize	Legacy branded product	Limited or discontinued branded significance
Generic griseofulvin microsize	Griseofulvin microsize	Current low-cost substitute	Principal source of supply where used
Generic griseofulvin ultramicrosize	Griseofulvin ultramicrosize	Alternative oral formulation	Smaller market than common generic microsize products

The market has also shifted toward terbinafine, itraconazole, fluconazole, and topical antifungals. These alternatives reduced demand for griseofulvin in several indications, although griseofulvin remains clinically relevant for some pediatric dermatophyte infections, particularly tinea capitis.

What is the FDA regulatory status of Fulvicin P/G?

Fulvicin P/G was an FDA-approved prescription drug product, but it is not a current growth product in the U.S. pharmaceutical market. FDA product databases distinguish between approval history and active commercial marketing. A product can remain in regulatory records after the brand is no longer actively marketed.

The regulatory trajectory is consistent with an old small-molecule product:

1. Original approval occurred decades ago.
2. Multiple generic griseofulvin products entered after regulatory and patent barriers expired.
3. The branded product lost market share through substitution and formulary pressure.
4. Commercial availability of the brand declined or ceased.
5. Generic manufacturers became the relevant suppliers.

FDA records do not indicate that the product’s market decline resulted from a safety withdrawal. The primary drivers were commercial obsolescence, generic competition, and therapeutic substitution.

What indications were associated with Fulvicin P/G?

The historical labeling for griseofulvin microsize covered dermatophyte infections involving:

• Scalp and hair
• Skin
• Groin
• Feet
• Nails

Treatment duration was often longer than for newer oral antifungals. This increased the commercial disadvantage of griseofulvin in markets where clinicians could choose shorter-course alternatives.

Griseofulvin remains subject to important prescribing limitations. It is not effective against infections caused by bacteria, Candida species, or most non-dermatophyte molds. The labeling also includes warnings relating to hepatic disease, lupus-like syndromes, photosensitivity, and drug interactions, including effects on hormonal contraception and warfarin therapy. [1]

What patents protected Fulvicin P/G?

The principal intellectual-property protection for Fulvicin P/G has expired. There is no commercially meaningful current patent exclusivity associated with the legacy brand.

IP category	Historical position	Current position
Griseofulvin active ingredient	Old, long-established molecule	Public-domain active ingredient
Microsize formulation	Historical formulation differentiation	Expired or commercially ineffective protection
Oral dosage form	Covered by old product and formulation rights	No practical exclusivity
Method-of-use rights	Historical dermatophyte-treatment uses	No meaningful current branded barrier
Manufacturing technology	Mature chemical and pharmaceutical process	Limited barrier to generic production
Brand trademark	Historical brand identifier	Does not block generic substitution

The original griseofulvin molecule was introduced well before the modern Hatch-Waxman patent system. Any patent rights that could have protected the active ingredient or original formulation expired many years ago. No current patent estate appears to support a premium branded market for Fulvicin P/G.

Are there current Orange Book patents for Fulvicin P/G?

No current Orange Book patent position is commercially material for Fulvicin P/G. The Orange Book can retain historical product information even when a product is no longer actively marketed. Patent listings, when present in historical records, do not create current exclusivity after expiration.

The relevant commercial conclusion is that a new generic manufacturer would not face a branded patent barrier based on the historical Fulvicin P/G product. Entry would instead depend on FDA approval, manufacturing economics, supply reliability, and demand.

When did Fulvicin P/G lose exclusivity?

Fulvicin P/G lost practical exclusivity decades ago. Its loss of exclusivity was not a single recent event comparable to the patent cliff for a modern blockbuster. Griseofulvin was an established generic compound before the current pharmaceutical patent-monitoring framework became commercially important for most products.

The product’s exclusivity erosion followed this sequence:

• Active-ingredient protection expired long ago.
• Formulation differentiation became insufficient to sustain brand pricing.
• Generic griseofulvin products entered the market.
• Pharmacies and payers substituted lower-cost versions.
• Branded distribution declined.
• Therapeutic alternatives further reduced demand.

The precise date on which the Fulvicin P/G brand ceased meaningful marketing is less important than the market structure: the brand has no current exclusivity period and no viable path to restore a premium position without a new formulation, new indication, or new delivery technology.

How strong is the patent estate for Fulvicin P/G?

The patent estate is effectively weak for current commercial purposes.

Composition-of-matter protection

There is no current composition-of-matter exclusivity. Griseofulvin is an old active pharmaceutical ingredient and is available through generic channels.

Formulation protection

The microsize formulation historically offered an absorption and dosing distinction from ultramicrosize formulations. That distinction supported product differentiation when the brand was new. It does not provide current market protection because the formulation concept is old and generic manufacturers can produce comparable products.

Method-of-use protection

The uses associated with Fulvicin P/G are conventional antifungal indications. They do not provide a commercially defensible method-of-use franchise today.

Manufacturing and know-how protection

Griseofulvin manufacturing is mature. Process know-how, particle-size control, tablet compression, dissolution, and stability remain relevant to FDA approval and product quality, but they are not substantial barriers to an established generic manufacturer.

Which companies are challenging or competing with Fulvicin P/G?

Fulvicin P/G is not currently positioned as an active branded product facing a conventional Paragraph IV challenge. The competitive field consists primarily of generic manufacturers and alternative antifungal products.

Generic competitors

Generic griseofulvin products have historically been supplied by multiple manufacturers, including companies operating through direct manufacturing, contract manufacturing, or authorized-generic channels. Supplier participation can change over time because the product has a small market and relatively modest commercial value.

The main competitive variables are:

• Product availability
• Wholesale acquisition cost
• Pharmacy reimbursement
• Pediatric demand
• Distributor inventory
• Tablet strength and dosage form
• Ability to maintain FDA-compliant supply

Therapeutic competitors

Griseofulvin competes with:

• Terbinafine
• Itraconazole
• Fluconazole
• Ketoconazole, in limited historical contexts
• Topical azole antifungals
• Topical allylamines
• Ciclopirox and related topical therapies

Terbinafine is particularly important for several nail and skin infections. Griseofulvin retains a more specialized role in some scalp infections and pediatric treatment settings.

What is the Paragraph IV challenge risk for Fulvicin P/G?

There is no significant current Paragraph IV risk to the Fulvicin P/G brand because no active branded patent barrier appears to support a protected market.

Paragraph IV litigation is relevant when a generic applicant certifies that a listed patent is invalid, unenforceable, or not infringed. For a legacy griseofulvin product with expired protection and no material current Orange Book patent estate, the commercial issue is not a new Paragraph IV entry event. Generic competition has already occurred.

A manufacturer seeking approval for a griseofulvin microsize product would be more likely to pursue an ordinary abbreviated new drug application pathway against expired or absent patent protection than to trigger strategically significant litigation.

What is the market size and revenue trajectory for Fulvicin P/G?

No public company currently reports standalone Fulvicin P/G revenue. The product is not a separately disclosed asset in the filings of a major pharmaceutical company, and historical sales data are not generally available through public financial statements.

The revenue trajectory can be characterized as follows:

Period	Revenue profile	Primary driver
Early commercial period	Branded prescription revenue	Limited systemic antifungal competition
Generic-entry period	Rapid decline in branded sales	Pharmacy substitution and price competition
Mature generic period	Low unit prices and fragmented supply	Commodity-like economics
Current period	No material branded revenue disclosed	Generic availability and therapeutic substitution

For a product of this age, revenue exposure is concentrated in the generic market rather than in the Fulvicin P/G brand. A generic supplier may generate modest product revenue, but the market is unlikely to support blockbuster economics.

What factors determine current griseofulvin revenue?

Current revenue is shaped by:

1. Pediatric dermatology demand, especially tinea capitis.
2. Prescriber preference relative to terbinafine and azole therapies.
3. Generic manufacturer participation.
4. Shortages or discontinuations affecting competing products.
5. Reimbursement policies.
6. Availability of specific tablet strengths and oral suspensions.
7. Regional differences in dermatophyte prevalence.

Supply disruptions can temporarily raise prices in small generic markets, but such events do not create durable brand value for Fulvicin P/G.

What manufacturing and supply barriers affect the product?

Manufacturing barriers are operational rather than patent-based. Griseofulvin products must meet requirements for identity, assay, dissolution, content uniformity, stability, and particle-size control. Microsize performance can affect absorption and clinical equivalence.

The most important barriers are:

• FDA-compliant manufacturing capacity
• Consistent particle-size distribution
• Validated dissolution performance
• Reliable active-ingredient sourcing
• Economically viable batch sizes
• Continued distributor and pharmacy demand

These requirements can cause temporary supply constraints, but they do not establish durable exclusivity. The product’s low price can also discourage manufacturers from maintaining capacity when production costs rise.

How does Fulvicin P/G compare with newer antifungal products?

Criterion	Fulvicin P/G / griseofulvin microsize	Terbinafine	Itraconazole
Brand status	Legacy or discontinued brand	Generic and branded history	Generic and branded history
Patent position	Expired	Core patents expired	Core patents expired
Main use	Dermatophyte infections, including pediatric scalp disease	Skin and nail dermatophytes	Broad fungal indications
Treatment duration	Often relatively long	Often shorter for some infections	Variable
Current price environment	Generic, low price	Generic, low price	Generic, low price
Differentiation	Pediatric and clinical familiarity	Efficacy and shorter courses in selected uses	Broader spectrum
Commercial outlook	Stable niche demand, limited growth	Larger competitive market	Larger therapeutic footprint

Griseofulvin’s remaining value is clinical rather than commercial. It can remain useful in specific patient populations even when the branded product has no meaningful financial trajectory.

What litigation and settlement agreements affect Fulvicin P/G?

No major current patent litigation or settlement agreement is commercially associated with Fulvicin P/G. The product’s patent profile is too old to support the type of litigation commonly seen for recently launched medicines.

The relevant legal risks are more likely to involve:

• FDA manufacturing compliance
• Product-quality enforcement
• Supply obligations
• Labeling accuracy
• Generic drug litigation unrelated to the historical brand
• Contract disputes involving distribution or supply

A modern branded-generic settlement framework is unlikely to be relevant to Fulvicin P/G because the core market exclusivity period has already ended.

What are the generic launch scenarios for Fulvicin P/G?

The most likely commercial scenarios are:

Continued low-volume generic supply

Generic griseofulvin remains available through one or more manufacturers, with limited pricing power and intermittent supply variability.

Further supplier exits

If demand declines or manufacturing costs increase, manufacturers may discontinue products or reduce production. This could create temporary shortages without restoring Fulvicin P/G brand value.

Stable pediatric niche

Persistent use in tinea capitis and other pediatric dermatophyte infections could support a small but durable generic market.

New formulation redevelopment

A company could seek commercial differentiation through an improved suspension, pediatric dosage form, adherence technology, or combination product. Such a strategy would require new clinical, regulatory, and commercial investment. It would not revive the historical Fulvicin P/G exclusivity position automatically.

Key Takeaways

• Fulvicin P/G is a legacy griseofulvin microsize brand with no material current branded-market position.
• Its original patents and formulation protections expired long ago.
• No meaningful current Orange Book patent barrier or Paragraph IV litigation risk is associated with the product.
• Generic griseofulvin and therapeutic alternatives have driven the financial decline.
• No standalone current revenue is publicly disclosed for Fulvicin P/G.
• The remaining market is a low-price generic niche, supported primarily by selected dermatophyte indications and pediatric demand.
• Current commercial risks relate to supply continuity, manufacturing economics, and therapeutic substitution rather than patent expiry.
• The product has residual clinical utility but limited investment value as a legacy branded asset.

FAQs

Is Fulvicin P/G still available in the United States?

The historical brand is not a material current U.S. commercial product. Griseofulvin microsize may remain available through generic products, subject to manufacturer and distributor supply.

Is Fulvicin P/G the same as Gris-PEG?

No. Both are griseofulvin products, but Fulvicin P/G is associated with the microsize formulation, while Gris-PEG is associated with an ultramicrosize formulation.

Does Fulvicin P/G have pediatric market value?

Yes, griseofulvin retains clinical relevance in some pediatric dermatophyte infections, especially tinea capitis. That clinical niche does not translate into meaningful branded exclusivity.

Can a company obtain new patents on griseofulvin microsize?

A company cannot reclaim expired active-ingredient protection. It could seek patents for a genuinely new formulation, delivery system, manufacturing process, or combination, but patentability and enforceability would depend on technical novelty and non-obviousness.

Would a griseofulvin shortage increase the value of Fulvicin P/G?

A shortage could increase short-term prices for available generic supply. It would not, by itself, restore the historical Fulvicin P/G brand or create durable patent protection.

References

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

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.

3. U.S. National Library of Medicine. (n.d.). Griseofulvin: Drug label information. DailyMed.

4. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. FDA.

5. World Health Organization. (2023). WHO guidelines for the treatment of skin and nail fungal infections. World Health Organization.