GRISEOFULVIN Drug Patent Profile

Which patents cover Griseofulvin, and what generic alternatives are available?

Griseofulvin is a drug marketed by Actavis Mid Atlantic, Chartwell Rx, Cipla, Cosette Pharms Nc, Sandoz, Sigmapharm Labs Llc, and Mountain. and is included in nine NDAs.

The generic ingredient in GRISEOFULVIN 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 Griseofulvin

A generic version of GRISEOFULVIN was approved as griseofulvin, ultramicrosize by MOUNTAIN on January 9^th, 2014.

Summary for GRISEOFULVIN

US Patents:	0
Applicants:	7
NDAs:	9

US Patents and Regulatory Information for GRISEOFULVIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Mid Atlantic	GRISEOFULVIN	griseofulvin, microsize	SUSPENSION;ORAL	065394-001	Jul 6, 2007	AB	RX	No	Yes
Sigmapharm Labs Llc	GRISEOFULVIN	griseofulvin, microsize	TABLET;ORAL	202482-001	Oct 22, 2012	AB	RX	No	No
Cosette Pharms Nc	GRISEOFULVIN	griseofulvin, microsize	SUSPENSION;ORAL	065438-001	Oct 8, 2010	AB	RX	No	No
Sigmapharm Labs Llc	GRISEOFULVIN,ULTRAMICROSIZE	griseofulvin, ultramicrosize	TABLET;ORAL	202545-001	Oct 22, 2012	AB	RX	No	No

Griseofulvin Investment Scenario and Patent/Regulatory Fundamentals Analysis (US and Key Markets)

Last updated: July 13, 2026

Executive summary: Griseofulvin is an established, off-patent antifungal with narrow modern blockbuster dynamics and pricing risk tied to low-cost generic competition. The US market is driven by generic tablets and oral suspension with limited differentiation; the investment case is mostly about supply-chain resilience, controlled entry into fragmented generics distribution, and any niche IP positions (formulations, particle size, manufacturing) rather than brand-like exclusivity. Net present value hinges on whether a company can (1) secure durable market access, (2) avoid FDA/CMC bottlenecks and compendial stability failures, and (3) defend against rapid Paragraph IV-style erosion if any Orange Book-listed patents still exist for a specific labeled presentation.

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What is griseofulvin’s business model and who buys it?

Short answer: Griseofulvin is prescribed primarily for dermatophyte (tinea) infections, with demand that tracks outpatient dermatology and pediatric dosing patterns more than hospital/acute care volume.

Core utilization drivers

• Indication focus: superficial fungal infections (commonly tinea corporis/capitis/pedis and related dermatophyte infections).
• Patient mix: high pediatric share for tinea capitis where systemic therapy is standard.
• Treatment course dynamics: finite duration per episode, limiting recurring revenue versus chronic franchises.

Commercial endpoints investors track

• Prescription volume trends by dosage form (tablets vs suspension) and payer reimbursement.
• Competitive pricing and gross-to-net compression under generic substitution.
• Availability risk (manufacturing outages) that can temporarily lift local market share for in-stock SKUs.

Investment implication

• The best value capture typically comes from low-cost, reliable manufacturing and distribution strength rather than marketing or broad lifecycle extensions.

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How strong is the griseofulvin patent estate and what patents protect it?

Short answer: Griseofulvin is generally treated as off-patent in the US for core active ingredient and broad therapeutic use. Any remaining exclusivity is likely tied to specific formulation or process patents for particular dosage forms or particle characteristics.

How the patent estate usually breaks down

• Active ingredient composition claims: typically long expired.
• Method-of-treatment claims: often expired due to long history and older clinical use.
• Formulation and manufacturing patents: can survive longer, but they are narrower and tied to a specific product line (for example, micronized particle size strategies, excipient systems, or manufacturing process controls).

Practical IP posture for investors

• Treat “griseofulvin patent estate” risk as presentation-specific:
  • Tablets and suspension can have different remaining IP footprints.
  • Even if an Orange Book listing exists, many generics can design around by changing particle size distribution, dosage form, or manufacturing method.

What to diligence

• Orange Book listings for each specific NDC you plan to compete with.
• Whether any unexpired patents remain for the particular dosage form you would supply.
• Whether patents are formulation/process-based where design-around is feasible.

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When does griseofulvin lose exclusivity in the US, and when can generics enter?

Short answer: If no active Orange Book patents remain for a listed product, entry can occur without Paragraph IV. If patents exist for a particular NDC, generic entry timing depends on the expiration date of those listed patents and any granted exclusivity blocks.

Exclusivity mechanics to model

• Patent expiration: drives the end of listed-patent exclusivity.
• 180-day exclusivity (Paragraph IV winner): can delay competitive erosion after a successful challenge.
• Exclusivity blocks tied to supplements: can delay non-patent-protected changes if they fall under exclusivity categories.

Investment implication

• A realistic generic launch model assumes fast follow-on entry after the first 180-day period unless the market is constrained by manufacturing capacity, stability requirements, or supply outages.

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What is the Orange Book status of griseofulvin formulations (tablets vs oral suspension)?

Short answer: Griseofulvin products in the US are predominantly generic and typically have limited current patent listings; any remaining Orange Book listings are usually concentrated around specific formulation/manufacturing patents.

What investors should map

• Each major labeled presentation:
  • Oral tablets (various strengths).
  • Oral suspension (various strengths).
• Each NDC’s Orange Book listings:
  • Patent number, expiration date, and patent category (composition vs method vs formulation).
  • Whether a patent is expired but still listed, which can mislead screens if not parsed carefully.

Risk

• “Orange Book noise” is common in older products. Investors should focus on active unexpired patents relevant to the specific dosage form and strength that drives revenue.

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What formulations are protected by patents for griseofulvin, and how can competitors design around?

Short answer: Remaining protected positions, when they exist, tend to be formulation and manufacturing method claims that can be bypassed with alternative particle size targets or different excipient/manufacturing approaches.

Design-around levers

• Micronization/particle size distribution targets (if patented).
• Solubilization and excipient systems affecting dissolution profile.
• Manufacturing method steps affecting crystal habit or reprocessing outcomes.

CMC bottlenecks

• Bioavailability can be sensitive to particle size and suspension characteristics.
• Suspension stability and uniformity (assay and content uniformity) are recurring operational risk points.

Investment implication

• The durability of any “IP moat” is usually weak unless the formulation is hard to reproduce without violating claimed ranges or without triggering bioequivalence failures.

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What generic entry risks exist for griseofulvin, including Paragraph IV challenges?

Short answer: Entry risk is mostly competitive and supply-chain driven rather than IP-driven because the category is widely genericized.

Where Paragraph IV can still matter

• If any Orange Book-listed patents remain for a specific NDC (often formulation or manufacturing), a Paragraph IV certification could be required to launch under AB-rated labeling.
• If any “first challenger” wins 180-day exclusivity, the market impact is time-phased but typically short-lived.

Investor risk checklist

• Certification strategy feasibility (validity and non-infringement positions).
• Likelihood of settlement terms that delay launch.
• Whether the target NDC has limited manufacturing routes that can act as de facto barriers even when legal barriers are weak.

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How does griseofulvin compare with newer antifungals from a competitive IP and pricing perspective?

Short answer: Griseofulvin competes with other systemic antifungals used for dermatophyte infections, but it is usually priced and positioned as an older, generic systemic option rather than a differentiated therapy.

Comparison dimensions that affect investment

• Payer preference and formulary placement: generics win on cost.
• Clinical positioning: newer agents (where used) can reduce dosing burden, but practice patterns still rely on older options in many settings.
• Adherence and safety profile tradeoffs: can influence clinician choice but usually not enough to overpower generic pricing once cost is decisive.

Investment implication

• Price compression is the dominant competitive variable; IP rarely offsets it in a mature generic antifungal.

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What patent litigation affects griseofulvin, and is there ongoing enforcement risk?

Short answer: In mature generic categories, litigation is sporadic and tends to be tied to specific NDCs with remaining Orange Book listings or to formulation/process updates. For griseofulvin specifically, the litigation footprint is typically not a sustaining risk driver unless a company is targeting a narrow, still-protected product presentation.

Litigation diligence focus

• Active cases involving griseofulvin NDCs you plan to supply.
• Whether settlements impose “carve-out” territories or agreed launch dates.
• Whether the defendant settled and then enforced against follow-on generics.

Investment implication

• The key litigation metric is not existence but whether any case imposes enforceable delays on the exact NDCs tied to your revenue forecast.

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What FDA regulatory status applies to griseofulvin, and what pathway matters for investors?

Short answer: US griseofulvin access is generally via Abbreviated New Drug Application (ANDA) routes, with pathway complexity mainly driven by bioequivalence and CMC adequacy for the specific dosage form.

Regulatory elements investors track

• Bioequivalence study feasibility by dosage form.
• Bioequivalence risk for suspensions due to particle size and dissolution behavior.
• Labeling constraints tied to dermatophyte indication and dosing schedules.

Operational risk

• FDA inspection outcomes for manufacturing facilities.
• Stability and quality performance for liquid forms.
• Regional recalls that can temporarily lift competitors while damaging your brandless supply continuity.

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What dosing forms and manufacturing risks are most material for griseofulvin revenue?

Short answer: Tablets and oral suspension have different CMC and stability risk profiles; the suspension is typically the higher operational burden.

Tablet manufacturing risks

• Content uniformity at low dose levels.
• Powder blending and milling consistency that impacts dissolution.

Suspension manufacturing risks

• Uniformity over shelf life (re-suspendability and settling control).
• Assay stability and degradation pathways.
• Viscosity and rheology affecting dosing accuracy.

Investment implication

• A plant with strong aseptic/sterile capabilities is not needed, but disciplined solid-state and suspension-formulation controls are.

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How many patents cover griseofulvin and what is the geographic coverage?

Short answer: Patent coverage is typically fragmented and weakly predictive of entry barriers because major patents are expired; geographic coverage is mostly relevant only for any remaining formulation/process IP.

Investment mapping approach

• Focus on jurisdictions that matter for your revenue:
  • US (Orange Book and ANDA).
  • EU (national/EP positions for formulation, if any).
  • UK (post-Brexit reliance on national registrations and EU lineage).
• Use NDC-level granularity for US; otherwise you risk mixing expired ingredient IP with potentially unexpired formulation claims.

Commercial implication

• Geographic expansion usually depends more on regulatory and manufacturing approvals than on patent enforcement once ingredient IP has lapsed.

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Which companies typically supply griseofulvin and how does that shape margins?

Short answer: The supply chain is generic-heavy, so margin structure is dictated by competition, procurement contracting, and availability rather than by brand differentiation.

What determines your likely margin range

• Bids in wholesaler and group purchasing organization (GPO) channels.
• Contract lengths and inventory turns.
• Supply continuity costs (quality systems, recall buffers, and rework rates).

Investment implication

• Entry is not the main problem; sustaining shelf placement after initial launches is.

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Investment scenario modeling: base case, downside, and upside

Short answer: Investment returns track (1) stable manufacturing uptime, (2) ability to avoid recall/quality events, and (3) competitive price dynamics after entry.

Base case (most likely)

• Market continues as low-margin generic category.
• Revenue ramps with standard launch timing.
• Price erosion is gradual but constant as additional suppliers compete.

Downside

• Suspension CMC/stability issues drive delay or post-market action.
• Quality event or manufacturing outage causes lost supply during peak tinea capitis season.
• Faster-than-expected price compression from larger competitors.

Upside

• You secure contracts that prevent immediate substitution and lock in volume.
• Competitors suffer supply constraints, allowing temporary market share gains.
• You defend a formulation niche with credible CMC performance and label acceptance.

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Key takeaways for investors

1. Griseofulvin is a mature, genericized antifungal where patents rarely create long runway; investment value comes from manufacturing reliability, supply continuity, and contract strategy.
2. Any remaining IP is likely presentation-specific (tablets vs suspension) and formulation/process-focused; Orange Book diligence at the NDC level is decisive.
3. Regulatory path complexity is manageable but suspension CMC risk is material; stability and uniformity drive execution success.
4. Competitive pricing is the dominant driver of margins; upside typically comes from competitor supply failures or procurement-driven lockups.
5. Litigation risk is not usually a primary variable unless an investor targets an NDC with unexpired Orange Book patents or an active enforcement event.

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FAQs

1. What is the most important regulatory risk for launching a generic griseofulvin oral suspension?
Stability and content uniformity over shelf life plus consistent suspension performance that supports bioequivalence and label acceptability.

2. Are composition-of-matter patents relevant to griseofulvin generic entry today?
Usually not for the active ingredient itself; the practical focus is on any unexpired formulation or manufacturing patents listed for specific NDCs.

3. Does 180-day exclusivity meaningfully impact griseofulvin pricing?
It can affect near-term pricing and volume for the first entrant in a specific NDC competition set, but erosion typically returns as follow-on generics launch.

4. Which griseofulvin dosage form is harder to manufacture competitively?
The oral suspension, due to suspension uniformity, settling control, and stability requirements.

5. What is the main driver of market share in low-price griseofulvin categories?
Wholesale/GPO contracting plus continuous availability; prescription switching is fast once supply and reimbursement are in place.

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References

No sources were provided in the prompt, and no cited materials can be listed without external document inputs.