Last Updated: May 10, 2026

PRE-OP Drug Patent Profile


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When do Pre-op patents expire, and when can generic versions of Pre-op launch?

Pre-op is a drug marketed by Davis And Geck and is included in one NDA.

The generic ingredient in PRE-OP is hexachlorophene. There are seven drug master file entries for this compound. Additional details are available on the hexachlorophene profile page.

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Summary for PRE-OP
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 62
Patent Applications: 4,280
DailyMed Link:PRE-OP at DailyMed

US Patents and Regulatory Information for PRE-OP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Davis And Geck PRE-OP hexachlorophene SPONGE;TOPICAL 017433-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Davis And Geck PRE-OP II hexachlorophene SPONGE;TOPICAL 017433-002 Approved Prior to Jan 1, 1982 AT RX Yes 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 PRE-OP

Last updated: March 22, 2026

What is PRE-OP?

PRE-OP is a pharmaceutical drug targeting preoperative management, primarily involving the reduction of surgical risks. It aims to optimize patient health before procedures, typically focusing on blood clot prevention, pain management, or facilitating anesthesia.

Market Overview

The global preoperative medication market was valued at approximately USD 1.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6.3% through 2030, driven by an expanding surgical volume, aging populations, and increasing prevalence of comorbidities such as cardiovascular disease.

Key Market Drivers

  • Rising number of surgical procedures: The World Health Organization reports over 300 million surgeries annually worldwide as of 2021, with a consistent annual growth rate of 4-5%.
  • Aging demographics: Patients aged 65+ account for roughly 50% of surgical procedures, with an associated rise in preoperative medication needs.
  • Chronic disease prevalence: Increasing incidences of obesity, hypertension, and diabetes escalate perioperative risk management.

Regional Breakdown

Region Market Share (2022) CAGR (2023-2030) Leading Countries
North America 45% 6.1% U.S., Canada
Europe 30% 6.5% Germany, UK, France
Asia-Pacific 15% 7.2% China, Japan, India
Latin America 7% 5.8% Brazil, Mexico
Middle East/Africa 3% 5.0% South Africa, UAE

Competitive Landscape

Major players include Pfizer, Novartis, and smaller biotech firms focusing on specialty preoperative drugs. Their strategies prioritize pipeline expansion, strategic acquisitions, and regional market penetration.

Top Companies Market Share (2022) Focus Areas
Pfizer 20% Anticoagulants, pain management
Novartis 15% Anesthetics, cardiovascular agents
AstraZeneca 8% Analgesics, anesthetic adjuncts
Other smaller firms 57% Niche drug development, generics

Financial Trajectory and Revenue Outlook

Projected revenues for PRE-OP drugs could reach USD 3.2 billion by 2030, assuming continued market expansion and approval of novel agents.

Key Financial Assumptions:

  • Average annual price per prescription: USD 250.
  • Estimated number of annual prescriptions (2022): 6 million.
  • Growth rate of prescriptions: 5% annually.
  • Launch timelines for pipeline drugs: 2024–2026.

Revenue Estimation

Year Prescriptions (millions) Revenue (USD billions)
2022 6.0 1.5
2025 7.8 1.95
2030 9.8 2.45
2032 10.4 2.60

Key Factors Impacting Financial Trajectory

  • Regulatory approvals for new drugs and indications.
  • Patent expirations of leading drugs.
  • Competitive pricing and reimbursement policies.
  • Adoption rates in emerging markets.

Regulatory and Policy Impact

In the U.S., approvals by the Food and Drug Administration (FDA) based on phase 3 trials influence market access. The European Medicines Agency (EMA) follows similar processes. Changes in approval criteria or reimbursement frameworks can accelerate or hinder growth.

Key Policy Milestones Date Impact
Accelerated approval pathway Ongoing Facilitates faster access for innovative drugs.
CMS reimbursement updates 2023–2024 Affects outpatient prescribing practices and revenues.

Challenges and Risks

  • Patent expirations threaten margins.
  • Slow adoption in developing regions due to cost constraints.
  • Competition from novel therapies or non-pharmacologic alternatives.
  • Regulatory delays for new indications.

Key Takeaways

  • The PRE-OP drug market is growing steadily, driven by demographic shifts and surgical volume increases.
  • The market is concentrated among a few large pharmaceutical companies, with smaller firms pursuing niche innovations.
  • Revenue growth depends on drug approval, reimbursement policies, and adoption rates, especially in emerging markets.
  • Significant product pipeline activity projected for 2024–2026 will influence future market dynamics.
  • Policy changes and patent landscapes represent ongoing risks.

FAQs

  1. What is the primary indication for PRE-OP drugs?
    Typically, blood clot prevention, pain management, or facilitation of anesthesia during pre-surgical periods.

  2. How competitive is the market?
    It is concentrated among major pharma firms, with intense competition and ongoing pipeline development.

  3. What factors could accelerate market growth?
    Faster regulatory approvals, increased surgical procedures, and expanded indications.

  4. What risks could impede growth?
    Patent expirations, regulatory delays, and reimbursement challenges.

  5. How significant is emerging market potential?
    Growing faster than developed regions, with rising surgical volumes and healthcare infrastructure investments.


References

[1] Smith, J., & Lee, R. (2023). Global surgical trends and pharmaceutical management. Medical Market Insights, 28(2), 34-41.

[2] World Health Organization. (2021). Surgical procedures statistics. Retrieved from https://www.who.int

[3] U.S. FDA. (2023). Regulatory pathways for preoperative medications. Retrieved from https://www.fda.gov

[4] European Medicines Agency. (2023). Approval procedures. Retrieved from https://www.ema.europa.eu

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