Share This Page
GRISEOFULVIN,ULTRAMICROSIZE Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Griseofulvin,ultramicrosize, and when can generic versions of Griseofulvin,ultramicrosize launch?
Griseofulvin,ultramicrosize is a drug marketed by Sigmapharm Labs Llc and is included in one NDA.
The generic ingredient in GRISEOFULVIN,ULTRAMICROSIZE 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,ultramicrosize
A generic version of GRISEOFULVIN,ULTRAMICROSIZE was approved as griseofulvin, ultramicrosize by MOUNTAIN on January 9th, 2014.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for GRISEOFULVIN,ULTRAMICROSIZE?
- What are the global sales for GRISEOFULVIN,ULTRAMICROSIZE?
- What is Average Wholesale Price for GRISEOFULVIN,ULTRAMICROSIZE?
Summary for GRISEOFULVIN,ULTRAMICROSIZE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Drug Prices: | Drug price information for GRISEOFULVIN,ULTRAMICROSIZE |
| DailyMed Link: | GRISEOFULVIN,ULTRAMICROSIZE at DailyMed |
Pharmacology for GRISEOFULVIN,ULTRAMICROSIZE
| Drug Class | Tubulin Inhibiting Agent |
| Physiological Effect | Decreased Mitosis Microtubule Inhibition |
US Patents and Regulatory Information for GRISEOFULVIN,ULTRAMICROSIZE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sigmapharm Labs Llc | GRISEOFULVIN,ULTRAMICROSIZE | griseofulvin, ultramicrosize | TABLET;ORAL | 202545-001 | Oct 22, 2012 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sigmapharm Labs Llc | GRISEOFULVIN,ULTRAMICROSIZE | griseofulvin, ultramicrosize | TABLET;ORAL | 202545-002 | Oct 22, 2012 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Griseofulvin, Ultramicrosize Market Dynamics and Financial Trajectory: Pricing, Demand, Competition, and IP-Driven Supply Risks
Executive summary: Griseofulvin, Ultramicrosize (oral antifungal; branded originator and generic-class product) is a mature, low-to-mid value chronic-demand portfolio with limited incremental innovation. Market outcomes are driven by (1) patent and exclusivity status of branded formulations in the US, (2) generic substitution economics and contracted wholesaler pricing, (3) supply continuity and manufacturing approvals across strengths, and (4) prescription share shifts due to newer antifungals and tighter formularies. Financial trajectory typically tracks overall dermatophyte treatment volumes rather than large stadium-indication expansion. Long-run risk centers on manufacturing scale-through, API sourcing constraints, and intermittent supply disruptions that can lift realized prices temporarily.
How big is the griseofulvin, Ultramicrosize market and what drives revenue?
Quick answer: The revenue pool is sized by the number of prescriptions for dermatophyte infections treated with systemic griseofulvin and by realized net price after rebates, chargebacks, and wholesaler discounts. Demand is structurally steadier than acute-care antifungals, but it is not growing fast because prescribers often shift to terbinafine or azoles when clinically appropriate.
Key demand drivers
- Indication mix: Dermatophytosis, including tinea corporis/cruris/capitis, and onychomycosis subsegments where systemic therapy is used.
- Prescriber practice patterns: Primary-care, dermatology, and pediatric prescribing influences volume because griseofulvin is used in children for certain scenarios.
- Guideline behavior: When guidelines favor terbinafine or itraconazole for specific organisms and sites, griseofulvin gains share mainly when dosing tolerability, organism susceptibility, contraindications, or formulary constraints support it.
- Formulary and payer levers: Tier placement, prior authorization rules, and step therapy alter switching, especially in commercial plans.
What moves quarterly sales
- Net price vs volume: Ultramicrosize products can command pricing differentials vs older griseofulvin presentations, but generic competition compresses net pricing over time.
- Distribution continuity: Any manufacturing interruption can shift pharmacy purchasing behavior, creating short-term price and volume rebounds.
- Seasonality: Dermatophyte presentations fluctuate modestly by season and school/pool exposure patterns, usually with smaller impacts than systemic antifungals for acute infections.
Is Griseofulvin Ultramicrosize a growing market or a declining one?
Quick answer: The market is mature and typically flat to declining in real terms, with occasional price spikes from supply constraints. Growth, when it appears, usually comes from temporary substitution away from competitors or from episodic shortages rather than sustained demand expansion.
Why the base case is flat
- Therapeutic class substitution: Terbinafine and azole systemic agents compete for the same dermatophyte indications.
- Generic erosion: In most markets, a griseofulvin branded “ultramicrosize” line is eventually faced by multiple generics with similar or acceptable bioequivalence profiles, reducing pricing power.
- Low switching friction to generics: Since the active ingredient is off-patent in many jurisdictions, pharmacies often view griseofulvin as a “fill-and-fill” product.
What can create growth pockets
- Supply gaps in competing drugs: If terbinafine/itraconazole availability is strained, griseofulvin can pick up incremental scripts.
- Payer-driven forced usage: When a plan’s formulary excludes a competitor, net volume can move quickly.
- Localized regulatory or quality events: Manufacturing quality events in the class can temporarily redirect purchasing.
What is the pricing trajectory for griseofulvin, Ultramicrosize?
Quick answer: Expect declining headline prices over time as generic entrants expand, with net price stabilization only when supply constraints or payer-specific contracting limit substitution.
Price path shaped by contract mechanics
- Wholesale acquisition vs net price: A “list price” can rise while net remains constrained by rebates and competitive discounts.
- Contracting with PBMs and wholesalers: Large channel intermediaries can set pass-through economics that compress revenue per prescription.
- Ingredient and packaging cost pass-through: Griseofulvin API and excipient costs influence gross-to-net.
Featured market behavior
- Post-shortage rebounds: When products re-enter stable supply, realizations typically drop unless contracts reset upward.
- Strength and formulation effects: Ultramicrosize presentations can maintain higher relative pricing than older griseofulvin formats, but competitive generics often narrow the differential.
Which companies sell griseofulvin, Ultramicrosize and how does competition work?
Quick answer: The competitive set typically includes branded originator suppliers plus multiple generic manufacturers across strengths. Competition is largely price-and-availability driven.
Commercial competition map (US-style)
- Originator branded ultramicrosize products: Compete on brand familiarity and channel relationships until generics dominate.
- Generic equivalents: Compete on unit price, supply reliability, and ability to meet demand during shortages.
Where market share is won
- Availability metrics: Pharmacy fill rate and patient access.
- Net pricing: Rebates and buying group discounts.
- Package size and strength assortment: Matching common dosing regimens reduces switching.
When does griseofulvin, Ultramicrosize lose exclusivity and what happens after launch of generics?
Quick answer: The branded ultramicrosize product’s exclusivity has typically already lapsed in most major markets given the long history of griseofulvin. The practical “exclusivity cliff” in financial terms is the period around generic entry, when pricing collapses and revenue shifts to whichever label remains best positioned on net price and supply.
Typical exclusivity-to-pricing sequence
- Branded period: Higher net price, limited generic pressure.
- Generic erosion: Multiple ANDA launches compress net price quickly.
- Consolidation: Residual market share concentrates with manufacturers able to sustain compliant supply.
- Long tail: Revenue stabilizes at a low per-unit level with intermittent price volatility due to manufacturing constraints.
Paragraph IV and Hatch-Waxman effects
- For mature actives like griseofulvin, the primary financial inflection usually occurs at generic launch rather than single Paragraph IV events, unless a branded formulation has later intellectual property.
What patents protect Ultramicrosize griseofulvin and how strong is the patent estate?
Quick answer: The patent estate for griseofulvin ultramicrosize, to the extent still relevant, generally narrows to formulation, particle size, process, and specific dosing or method claims. In financial terms, remaining patents mostly affect “label-specific” versions rather than the underlying active ingredient once broad composition and earlier formulations expire.
Patent estate categories that matter to commercialization
- Formulation patents: Particle size distributions and formulation components that affect dissolution and absorption.
- Manufacturing/process patents: Milling, micronization controls, spray-drying or granulation steps tied to ultramicrosize performance.
- Method-of-use patents: Dosing regimens or patient subpopulations, less common for mature actives.
- Polymorph/crystal form (if claimed): Less common for griseofulvin but can appear for long-lived formulation IP.
How patent strength shows up in the market
- Sustained brand premium: If formulation patents remain, branded products can retain a net pricing advantage.
- Narrow generic carve-outs: If generics can launch only for certain strengths or packaging, the market can stay split longer.
What generic entry risks exist for griseofulvin, Ultramicrosize?
Quick answer: The key risks are not only legal, but operational: inability to replicate particle size characteristics, inconsistent dissolution profiles, and manufacturing quality constraints that can delay or limit supply.
Operational risk channels
- Micronization control: Ultramicrosize depends on tight particle size distribution.
- Bioequivalence variability: Generic acceptance depends on demonstrating comparable exposure.
- Regulatory inspection outcomes: Manufacturing sites can face delays that interrupt supply.
Financial risk channels
- Inventory write-downs: Manufacturers may face demand swings if supply is interrupted or if competitors undercut price.
- Margin compression: As more units qualify, average selling price declines unless manufacturing cost structures are favorable.
What is the FDA regulatory status of griseofulvin, Ultramicrosize and what does that imply for sales?
Quick answer: For mature molecules like griseofulvin, FDA status typically translates into a well-established ANDA/generic ecosystem. The financial implication is less about regulatory novelty and more about the pace of generic approvals, label additions (strengths), and product continuity.
Regulatory mechanics that influence volume
- ANDA shelf availability: The number of approved equivalents supports low switching costs.
- Label expansions: Additional strengths or dosage form updates can increase total addressable prescriptions.
- Safety communications: Mature oral antifungals can still face labeling updates that affect prescribing and adherence.
Orange Book impact in practice
- Exclusivity listings: Any remaining “listed drug” exclusivity or patents can delay certain generic filings or narrow label scope.
- Generic substitution rules: Once multiple therapeutically equivalent products exist, substitution behavior shifts to contracts and pharmacy stocking.
How does Griseofulvin Ultramicrosize compare with terbinafine and azoles on market dynamics?
Quick answer: Terbinafine and systemic azoles compete for systemic dermatophyte treatment. Griseofulvin’s market position is often residual and payer-dependent, with share sensitive to guideline preference and formulary placement.
Competitive comparison drivers
- Prescriber preference: Terbinafine frequently wins for many onychomycosis patterns, while griseofulvin may be selected in pediatric contexts or specific contraindication scenarios.
- Dosing schedule and duration: Treatment course length and adherence influence realized outcomes and patient drop-off rates.
- Safety/tolerability: Liver monitoring requirements and adverse event profiles can affect prescribing decisions.
Commercial impact
- When terbinafine/azole coverage is broad, griseofulvin faces steady volume pressure.
- When access to competitors is constrained by formulary edits or supply, griseofulvin can gain short-term scripts.
What litigation or settlements affect griseofulvin Ultramicrosize availability and price?
Quick answer: For mature molecules, litigation impacts are usually episodic and tied to formulation-specific patents. The financial signature is delayed generic launch or “partial entry” that can preserve a temporary brand premium.
Litigation pathways that matter
- Hatch-Waxman ANDA patent disputes: Can delay approvals and create settlement-based “authorized generic” arrangements.
- Formulation patent disputes: If ultramicrosize-specific claims are asserted, generic entry can be restricted to non-infringing particle-size distributions.
What to look for in financial tracking
- Launch timing: Date of generic availability in pharmacies is often the real KPI.
- Price behavior: Rapid ASP drops coincide with new generic entries.
- Market concentration shifts: After litigation, one or two compliant suppliers can dominate.
How do supply constraints and manufacturing capacity change the financial trajectory?
Quick answer: Supply disruptions create short-term price lift and volume shifts, but they can also force treatment delays and reduce total demand capture during the disruption window.
Supply risk economics
- Shortage premium: Limited channel inventory increases net price temporarily.
- Backorder effect: Prescribers may switch to alternatives during backorders.
- Manufacturing remediation costs: Quality holds can increase costs and reduce throughput, pressuring margins.
Long-run effects
- A single supplier gaining reliability can take share, depressing returns for less reliable competitors.
- If multiple suppliers exit due to quality or compliance failures, market pricing can stabilize at a higher level than in a fully competitive state.
What are the revenue and margin implications for branded holders vs generic manufacturers?
Quick answer: Branded ultramicrosize holders typically see declining margins as generics expand, with residual profit tied to brand premium and contract positioning. Generic manufacturers monetize through volume and manufacturing efficiency, with margins highly sensitive to raw material cost, utilization rates, and price compression.
Branded-holder financial pattern
- Higher ASP early, compressing after generic entry.
- Margin support declines as rebates and competitive discounts rise.
Generic financial pattern
- Unit revenue declines with additional entrants.
- Margin stabilizes if manufacturing yield and compliance performance reduce cost of goods sold and rework risk.
Key takeaways
- Mature demand with competitive price pressure: Griseofulvin, Ultramicrosize is largely a stable dermatophyte treatment market, with financial trajectory driven by generic substitution.
- Net pricing is the main swing factor: Realized revenue moves with wholesaler contracting, rebates, and supply continuity.
- IP matters mainly for formulation-specific versions: Remaining patents, if any, are most likely to affect ultramicrosize-specific particle size and manufacturing/process claims rather than the active itself.
- Operational supply risk can temporarily lift financial outcomes: Price rebounds can occur during supply constraints, but prescriber switching to alternatives can cap recovery.
- Competition is rule-based, not innovation-led: Terbinafine and azoles create persistent share pressure through guidelines and payer coverage.
FAQs
1) Does ultramicrosize griseofulvin have different market pricing than older griseofulvin products?
Yes. Particle-size-driven bioavailability claims can sustain a relative premium versus older presentations, but generic entry usually narrows the differential over time.
2) How fast do griseofulvin revenues typically decline after generic launches?
In mature oral products, price compression often accelerates within the first 6 to 12 months after multiple ANDA equivalents become widely stocked.
3) Are there specific strengths or package sizes that drive most griseofulvin, Ultramicrosize sales?
Sales concentrate in strengths that align with common dosing regimens and in package sizes that reduce pharmacy dispensing friction.
4) Can supply shortages move market share away from griseofulvin even when it is stocked later?
Yes. During shortages, prescribers often switch to alternatives; when supply normalizes, some switched patients do not return immediately.
5) Is the financial trajectory more sensitive to volume or price for griseofulvin, Ultramicrosize?
Price. Real demand is relatively stable, but net revenue per unit is more sensitive to competition and contract economics.
References
No sources were provided in the prompt, and no drug-specific Orange Book, litigation, or market financial data can be cited without external documents.
More… ↓
