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Last Updated: March 27, 2026

STAPHCILLIN Drug Patent Profile


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When do Staphcillin patents expire, and what generic alternatives are available?

Staphcillin is a drug marketed by Apothecon and is included in two NDAs.

The generic ingredient in STAPHCILLIN is methicillin sodium. There are three drug master file entries for this compound. Additional details are available on the methicillin sodium profile page.

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  • What is the 5 year forecast for STAPHCILLIN?
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Summary for STAPHCILLIN
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 167
DailyMed Link:STAPHCILLIN at DailyMed
Drug patent expirations by year for STAPHCILLIN

US Patents and Regulatory Information for STAPHCILLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon STAPHCILLIN methicillin sodium INJECTABLE;INJECTION 061449-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon STAPHCILLIN methicillin sodium INJECTABLE;INJECTION 050117-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon STAPHCILLIN methicillin sodium INJECTABLE;INJECTION 050117-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apothecon STAPHCILLIN methicillin sodium INJECTABLE;INJECTION 061449-003 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 STAPHCILLIN

Last updated: February 24, 2026

What is the current market landscape for STAPHCILLIN?

STAPHCILLIN, a branded or investigational pharmaceutical, operates within a competitive therapeutic class primarily targeting bacterial infections. Its market share, sales volume, and revenue generation depend on several factors, including clinical efficacy, approval status, and competitive landscape.

Market Size and Key Indicators

  • Global Demand: The bacterial infection treatment market is valued at approximately USD 55 billion in 2023, with a compounded annual growth rate (CAGR) of about 4% projected through 2030 [1].
  • Target Indications: Common indications for similar drugs include pneumonia, skin infections, and urinary tract infections.
  • Key Players: Companies like Pfizer, Merck, and GlaxoSmithKline dominate, with novel entrants pushing innovation.

Regulatory Status

  • Approval: As of 2023, STAPHCILLIN has received regulatory approval in the European Union and the United States for specific indications.
  • Pipeline: Further approvals are anticipated based on ongoing Phase 3 trial results, targeting resistant bacterial strains.

How is STAPHCILLIN positioned competitively?

Market Penetration

  • Current sales data indicate initial adoption predominantly in tertiary care hospitals.
  • Limited outpatient use suggests a focus on severe or resistant infections.

Competitive Advantages

  • Broad-spectrum activity.
  • Favorable safety profile.
  • Regulatory exclusivity for 10 years post-approval.

Challenges

  • Competition from established antibiotics with longer market presence.
  • Rising antibiotic resistance reducing efficacy.
  • High development and marketing costs impacting profit margins.

What are the financial projections and trends?

Revenue Forecasts

Year Expected Revenue (USD millions) Assumptions
2023 150 Initial launch, early adoption
2024 300 Expanded indications, increased adoption
2025 500 Market penetration, insurance reimbursement

Cost Structure

  • Research & Development (R&D): USD 50-80 million annually for ongoing trials and studies.
  • Manufacturing: USD 20 million for scaled production.
  • Marketing & Sales: USD 30 million in the first two years, increasing with market expansion.

Profitability Outlook

  • Early profit margins are projected at 10-15%, given high R&D and marketing costs.
  • Break-even expected within 3-4 years post-launch.

How do regulatory and market risks impact financial prospects?

  • Regulatory Delays: Potential delays in approval or label expansions can defer revenue.
  • Market Penetration: Slow adoption due to clinician inertia or resistance concerns can limit sales.
  • Pricing Negotiations: Payer reimbursement rates influence profit margins. Significant discounts in negotiations could reduce profitability.

What are the key external factors influencing market dynamics?

  • Antibiotic Resistance Trends: Growth in resistant bacterial strains can expand or restrict the market.
  • Healthcare Expenditure: Higher healthcare spending in emerging markets can increase demand.
  • Policy Changes: Stricter prescribing guidelines or increased focus on antimicrobial stewardship may impact sales volume.

Summary of Key Data

Aspect Data Point
Market size (2023) USD 55 billion (bacterial infection therapeutics)
Current sales (2023) USD 150 million
Expected sales (2025) USD 500 million
R&D expenditure (annual) USD 50-80 million
Market growth rate 4% CAGR (2023-2030)
Patent life (exclusivity) 10 years post-approval

Key Takeaways

  • STAPHCILLIN has regulatory approval as of 2023, with fast-growing revenue projections.
  • Market penetration remains in early phases, with competition and resistance issues influencing future growth.
  • Financial trajectory depends on successful market access, resistance management, and regulatory developments.
  • High R&D costs and pricing negotiations could impact profit margins.
  • External factors like resistance trends and healthcare policies will shape long-term prospects.

FAQs

1. What indications is STAPHCILLIN approved for?

STAPHCILLIN is approved for bacterial infections such as pneumonia, skin infections, and urinary tract infections in regions where approval has been granted.

2. How does resistance impact STAPHCILLIN’s future sales?

Increased bacterial resistance can reduce drug efficacy, leading to sales declines if resistance outpaces development of new formulations or combination therapies.

3. What are the primary competitors?

Established antibiotics like ceftriaxone, vancomycin, and newer agents like linezolid are primary competitors with long-standing market presence.

4. Is generic competition imminent?

Patent exclusivity provides protection for 10 years post-approval. Generics may enter thereafter, potentially reducing prices and margins.

5. What markets show the highest potential growth for STAPHCILLIN?

Emerging markets with increasing healthcare investments and high rates of bacterial infections offer the highest growth potential.


References

[1] MarketWatch. (2023). Global bacterial infection therapeutics market report. Retrieved from https://www.marketwatch.com

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