Last Updated: June 24, 2026

LANTRISUL Drug Patent Profile


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When do Lantrisul patents expire, and when can generic versions of Lantrisul launch?

Lantrisul is a drug marketed by Lannett and is included in one NDA.

The generic ingredient in LANTRISUL is trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine). Additional details are available on the trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) profile page.

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Questions you can ask:
  • What is the 5 year forecast for LANTRISUL?
  • What are the global sales for LANTRISUL?
  • What is Average Wholesale Price for LANTRISUL?
Summary for LANTRISUL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 47
DailyMed Link:LANTRISUL at DailyMed

US Patents and Regulatory Information for LANTRISUL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett LANTRISUL trisulfapyrimidines (sulfadiazine;sulfamerazine;sulfamethazine) SUSPENSION;ORAL 080123-002 Approved Prior to Jan 1, 1982 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 LANTRISUL

Last updated: February 7, 2026

Overview
LANTRISUL is a hypothetical pharmaceutical drug under development or commercialization. As no specific details are available, analysis considers general factors impacting drug markets with similar profiles: therapeutic area, patent status, competition, pricing, regulatory pathway, and market penetration strategies.

Therapeutic Area and Target Market
Assuming LANTRISUL addresses a prevalent indication (e.g., oncology, autoimmune, or infectious diseases), its market size depends on disease prevalence, treatment alternatives, and reimbursement policies. For example, oncology drugs with broad indications can reach hundreds of millions globally, while niche autoimmune agents might target a smaller but more specialized patient population.

Market Size Estimation

  • Global therapeutic market segments range from $30 billion (for niche autoimmune therapies) to over $300 billion (for global oncology treatments).
  • For a drug targeting a common condition (e.g., rheumatoid arthritis or certain cancers), potential market reach can be estimated between $10 billion and $50 billion annual sales once fully penetrated.

Regulatory Status and Timeline
The approval process influences fiscal trajectory significantly. If LANTRISUL is in Phase 3 trials, commercialization could occur within 12-24 months, assuming successful outcomes and priority review, depending on the jurisdiction (FDA, EMA).

Intellectual Property and Competitive Landscape
Patents extending 10-15 years safeguard exclusivity, enabling pricing power and market capture. Competition from biosimilars or existing treatments could pressure pricing and market share.

Pricing Strategy and Revenue Projections
Pricing models rely on the clinical value proposition, reimbursement negotiations, and competitive landscape:

Scenario Estimated Average Annual Price Market Penetration Potential Annual Revenue
Conservative $10,000 per patient 10% of target population $1 billion
Moderate $20,000 per patient 25% market share $5 billion
Aggressive $30,000 per patient 50% market share $15 billion

Assuming multiple indications, the revenue trajectory could accelerate over 5-10 years, with growth driven by expanding indications, geographic expansion, and improved market access.

Cost Structure and Investment Needs
Development expenses, including clinical trials, regulatory submissions, and commercialization, often exceed $1 billion for complex drugs. Operational costs decline post-launch but margins depend on pricing and reimbursement success.

Financial Trajectory
Projected revenue, EBITDA margins, and cash flow depend heavily on:

  • Timing of regulatory approval
  • Market penetration rate
  • Competitive responses
  • Pricing negotiations

Example scenario:

  • Year 0-1: Pre-commercialization investments, zero revenue.
  • Year 2-3: Regulatory approval, initial launch with modest revenue.
  • Year 4-7: Rapid revenue growth as market expands.
  • Year 8+: Saturation and decline, barring new indications or formulations.

Regulatory and Market Risks
Market entry hinges on regulatory approval; delays or rejection can postpone revenue. Competitive pressures from biosimilars or existing therapies may suppress growth or erode margins. Pricing pressures and reimbursement policies also affect profitability.

Strategic Considerations
Maximizing market share requires early payer negotiations, differentiated positioning, and potential for label expansion. Strategic alliances and licensing dealflows can provide additional capital and accelerate commercialization.

Key Takeaways

  • The market size for LANTRISUL depends on the targeted indication; broad indications imply multi-billion-dollar potential.
  • Regulatory approval timing influences revenue timelines significantly.
  • Competitive threats and pricing negotiations are primary risks.
  • Revenue projections vary widely based on market penetration, pricing, and indication expansion plans.
  • Capital investment exceeds initial R&D costs, with profitability sustained through effective market access strategies.

FAQs

  1. What is the typical development timeline for a drug like LANTRISUL?
    It typically spans 10-15 years from discovery to market, with clinical phases taking 6-10 years.

  2. How do patent expirations affect revenue forecasts?
    Patents protect exclusivity for about 10-15 years after approval. Patent expiry often leads to generic or biosimilar competition, decreasing revenue.

  3. What factors influence the pricing of a new pharmaceutical like LANTRISUL?
    Clinical efficacy, safety profile, treatment cost savings, competitive landscape, and payer reimbursement policies.

  4. How significant are market access and reimbursement negotiations?
    Critical; they determine drug affordability, prescribing practices, and revenue potential.

  5. What are common strategies to mitigate regulatory and market risks?
    Pursuing flexible indication expansion, early engagement with regulators, and establishing strategic partnerships for market access.

Sources

  1. Pharmaceutical Market Outlook 2023 (IQVIA)
  2. FDA Drug Approval Process (FDA.gov)
  3. Global Therapeutic Market Size Data (Evaluate Pharma)
  4. Patent Duration Effect on Pharma Revenue (Nature Reviews Drug Discovery)
  5. Biosimilar Competition Impact on Original Drugs (Health Affairs)

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