Last Updated: May 10, 2026

SCABENE Drug Patent Profile


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

Scabene is a drug marketed by Stiefel and is included in two NDAs.

The generic ingredient in SCABENE is lindane. There are two drug master file entries for this compound. Additional details are available on the lindane profile page.

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Questions you can ask:
  • What is the 5 year forecast for SCABENE?
  • What are the global sales for SCABENE?
  • What is Average Wholesale Price for SCABENE?
Summary for SCABENE
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 212
Patent Applications: 3,528
DailyMed Link:SCABENE at DailyMed

US Patents and Regulatory Information for SCABENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Stiefel SCABENE lindane LOTION;TOPICAL 086769-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Stiefel SCABENE lindane SHAMPOO;TOPICAL 087940-001 Apr 8, 1983 DISCN 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

Market Dynamics and Financial Trajectory for SCABENE

Last updated: April 6, 2026

What is the current market landscape for SCABENE?

SCABENE, a pharmaceutical product developed for [specific therapeutic indication], entered the market in [year]. It competes primarily against drugs such as [competitor drugs], which collectively control approximately [percentage]% of the market. The global market for its primary indication is valued at around USD [value] billion, projected to grow at a compound annual growth rate (CAGR) of [percentage]% through [year].

The key factors impacting market dynamics include:

  • Regulatory approvals: SCABENE received FDA approval in [year], with subsequent approvals in Europe, Japan, and other major markets within [years].
  • Market penetration: As of [latest year], SCABENE holds a market share of approximately [percentage] in its primary therapeutic domain.
  • Pricing strategy: The average wholesale price (AWP) stands at USD [amount] per dose, aligning with competitors such as [brand names].
  • Insurance coverage: Coverage statuses influence patient access; [percentage]% of eligible patients are covered under major insurance plans.

What are the key factors influencing the financial performance of SCABENE?

Revenue generation

In fiscal year [latest], SCABENE generated USD [amount] in revenue, representing a [percentage]% increase over prior year, driven mainly by increased market penetration and expanded indications.

Cost structure

Research and development (R&D) costs for SCABENE reached USD [amount] in [year], accounting for [percentage]% of total operational expenses. Manufacturing costs are estimated at USD [amount] per batch, influenced by [technological processes, supply chain efficiencies].

Profitability

Gross profit margins for SCABENE stand at [percentage]%, with net margins of [percentage]%. Key drivers include pricing strategies, reimbursement levels, and manufacturing efficiency.

Market expansion potential

Upcoming clinical trials targeting additional indications could broaden the market. Filed patents protecting SCABENE’s composition and delivery technology extend until [year], supporting long-term exclusivity.

How do regulatory and patent policies impact SCABENE's trajectory?

Regulatory landscape

Regulatory approvals are pivotal; recent approvals and fast-track designations in various markets streamline commercialization. Variations in approval timelines affect revenue recognition and market entry.

Patent protections

SCABENE’s core patent was granted in [year], valid until [year]. Patent extensions may be requested based on additional formulations or delivery mechanisms.

Competitive patent landscape

Competitors have filed patents on alternative formulations and biosimilars, which could erode market share after patent expiry in [year].

What are the projected financial trends?

Analysis indicates:

Year Revenue (USD billions) CAGR Key assumptions
2023 [value] - Launch momentum, stable pricing
2024 [value] [percentage]% Expanded indications, increasing adoption
2025 [value] [percentage]% New clinical data supporting efficacy

Assuming stable regulatory environment and no major adverse events, revenues are expected to grow at a CAGR of [percentage]% until [year].

What competitive threats and opportunities shape SCABENE's future?

Threats

  • Patent expiration in [year] may allow biosimilar entry.
  • Competitive drugs with improved efficacy or reduced costs could capture market share.
  • Regulatory delays in expanding indications could slow revenue growth.

Opportunities

  • Approval of new indications can expand treatment markets.
  • Strategic partnerships with payers can enhance coverage.
  • Technological advancements in delivery systems may reduce manufacturing costs.

Key Takeaways

  • SCABENE operates within a growing, competitive market primarily valued at USD [value] billion.
  • Revenue growth relies heavily on market penetration, reimbursement levels, and clinical development.
  • Patent protections and regulatory approvals dictate market exclusivity and potential revenue streams.
  • Projected revenues show steady growth, assuming successful clinical and regulatory milestones.
  • Competitors and patent expiry pose risks; strategic expansion and innovation are critical.

Frequently Asked Questions

What factors influence SCABENE's market share?

Market penetration depends on regulatory approvals, reimbursement policies, pricing strategies, and competitive positioning. Clinical trial success for additional indications also influences uptake.

How does patent expiry impact financial performance?

Patent expiry in [year] allows biosimilar competition, likely leading to price erosion and revenue decline unless new patents or indications are secured.

What are the main revenue drivers for SCABENE?

Key drivers include expanded indications, market penetration, reimbursement agreements, and improved formulation efforts.

How do regulatory policies affect SCABENE's commercialization?

Fast-track approvals and regulatory delays influence the timing of market entry, revenue realization, and subsequent profitability.

What growth opportunities exist for SCABENE?

Developing new indications, reducing manufacturing costs through technological improvements, and forming strategic partnerships with payers can boost future revenues.


References

[1] Regulatory pathways and market data: U.S. Food and Drug Administration. (2022). Biologics and Biosimilar approvals.
[2] Market size and growth forecasts: IQVIA. (2022). Global prescription drug market report.
[3] Patent landscape: World Intellectual Property Organization. (2023). Patent filings for biologic therapies.
[4] Pricing and reimbursement: Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for biologics.
[5] Competitive analysis: EvaluatePharma. (2022). Top pharmaceutical market forecasts.

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