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Last Updated: December 22, 2024

STERI-STAT Drug Patent Profile


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Which patents cover Steri-stat, and when can generic versions of Steri-stat launch?

Steri-stat is a drug marketed by Matrix Medcl and is included in one NDA.

The generic ingredient in STERI-STAT is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Steri-stat

A generic version of STERI-STAT was approved as chlorhexidine gluconate by BECTON DICKINSON on October 24th, 1989.

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Summary for STERI-STAT
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 42
Patent Applications: 7,385
DailyMed Link:STERI-STAT at DailyMed
Drug patent expirations by year for STERI-STAT

US Patents and Regulatory Information for STERI-STAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Matrix Medcl STERI-STAT chlorhexidine gluconate SOLUTION;TOPICAL 070104-001 Jul 24, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

STERI-STAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sterile Compounding and Related Markets

Introduction to Sterile Compounding

Sterile compounding involves the preparation of customized medications in a sterile environment to ensure patient safety and efficacy. This sector is closely tied to the broader pharmaceutical and healthcare industries, which are experiencing significant growth and transformation.

Market Size and Growth

The sterile compounding pharmacies market has seen robust growth in recent years. In 2023, the market size was valued at $4.99 billion and is projected to grow to $5.3 billion in 2024 at a compound annual growth rate (CAGR) of 6.4%[4].

By 2028, the market is expected to reach $6.7 billion, driven by factors such as the rise in chronic diseases, an aging population, and advancements in precision medicine. This growth trajectory indicates a strong and stable financial outlook for the industry.

Key Drivers of Growth

Patient Safety Concerns

Patient safety has been a significant driver, with a shift towards ensuring that medications are free from contamination and tailored to individual patient needs[4].

Personalized Medicine

The trend towards personalized medicine has increased demand for customized and sterile compounded medications, contributing to market growth[4].

Home Infusion Therapies

The rise in home infusion therapies has also boosted the demand for sterile compounded drugs, as these therapies often require specialized and sterile preparations[4].

Clinical Trials and Investigational Drugs

Clinical trials and the development of investigational drugs have further fueled the growth of the sterile compounding market, as these drugs often require sterile and precise formulations[4].

Market Segmentation

The sterile compounding pharmacies market is segmented by product, therapeutic area, route of administration, and end-users.

By Product

The market includes segments such as injectables, nasal, ocular, and otic preparations. Injectables are a significant segment due to their widespread use in various therapeutic areas[4].

By Therapeutic Area

Therapeutic areas include hormone replacement therapy, pain management, dermatology, oncology, hematology, and dental care, among others. Oncology and pain management are particularly significant due to the high demand for customized medications in these areas[4].

By Route of Administration

The routes of administration include intravenous, intramuscular, and subcutaneous. Intravenous preparations are critical due to their use in hospital settings and home infusion therapies[4].

By End-Users

The market caters to adults, pediatrics, geriatrics, and veterinary patients. The aging population and increasing healthcare needs have driven growth in the adult and geriatric segments[4].

Financial Trajectory

Historic Performance

The sterile compounding pharmacies market has grown strongly in the historic period, driven by patient safety concerns, the shift towards personalized medicine, and the rise in home infusion therapies[4].

Forecasted Growth

The market is expected to continue its strong growth trajectory, reaching $6.7 billion by 2028. This growth will be driven by the rise in chronic diseases, advancements in precision medicine, and increased focus on patient-centric care[4].

Major Trends

Automation and Robotics Integration

The integration of automation and robotics is a significant trend, aimed at improving efficiency and reducing the risk of contamination in sterile compounding processes[4].

Stringent Regulatory Compliance

Compliance with stringent regulatory standards is crucial for maintaining market integrity and ensuring patient safety. This trend is expected to continue, driving investments in compliance measures[4].

Personalized Medicine and Specialized Compounds

The emphasis on personalized medicine continues to drive the demand for specialized and customized compounds, which is a key growth area for the market[4].

Shift to Outsourced Compounding Services

There is a growing trend towards outsourcing compounding services, which is expected to continue as healthcare providers seek to optimize costs and improve efficiency[4].

Related Markets: Pharmaceutical Sterility Testing

The pharmaceutical sterility testing market is closely related to the sterile compounding market, as it ensures the safety and efficacy of pharmaceutical products.

Market Size and Growth

The pharmaceutical sterility testing market was valued at $1.41 billion in 2023 and is expected to grow to $1.54 billion in 2024 at a CAGR of 9.0%. By 2028, it is projected to reach $3.18 billion at a CAGR of 20.0%[1].

Key Drivers

The growth in this market is driven by the rising demand for quality pharmaceutical products, growing emphasis on drug safety and efficacy, and the increasing prevalence of infectious diseases[1].

Impact of Demographic and Healthcare Trends

Aging Population

The aging population and the subsequent increase in healthcare needs have significantly impacted both the sterile compounding and pharmaceutical sterility testing markets. This demographic shift has driven demand for medications and ensured a steady growth trajectory for these markets[3][4].

Increased Health Insurance Coverage

The number of consumers with private health insurance has strengthened, driving demand for prescriptions and supporting revenue gains in the pharmacies and drug stores industry, which is closely linked to the sterile compounding market[3].

Technological Advances and Innovations

Advanced Analytical Techniques

The adoption of advanced analytical techniques and rapid microbiological methods is transforming the pharmaceutical sterility testing market, enabling faster and more accurate testing processes[1].

Data Integrity and Digitalization

Data integrity and digitalization are becoming critical in both sterile compounding and pharmaceutical sterility testing, ensuring that all processes are transparent, traceable, and compliant with regulatory standards[1].

Key Takeaways

  • The sterile compounding pharmacies market is expected to grow significantly, driven by patient safety concerns, personalized medicine, and advancements in precision medicine.
  • The pharmaceutical sterility testing market is also growing rapidly, driven by the need for quality pharmaceutical products and drug safety.
  • Automation, robotics, and advanced analytical techniques are key trends shaping these markets.
  • Demographic changes, such as an aging population and increased health insurance coverage, are supporting market growth.
  • Stringent regulatory compliance and data integrity are crucial for maintaining market integrity.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of the sterile compounding pharmacies market by 2028? A: The sterile compounding pharmacies market is expected to reach $6.7 billion by 2028[4].

Q: What are the key drivers of growth in the pharmaceutical sterility testing market? A: The key drivers include the rising demand for quality pharmaceutical products, growing emphasis on drug safety and efficacy, and the increasing prevalence of infectious diseases[1].

Q: How is the aging population impacting the sterile compounding market? A: The aging population is driving demand for medications, particularly in therapeutic areas such as oncology and pain management, contributing to market growth[4].

Q: What role does automation play in the sterile compounding market? A: Automation and robotics integration are improving efficiency and reducing the risk of contamination in sterile compounding processes, which is a significant trend in the market[4].

Q: How does data integrity impact the pharmaceutical sterility testing market? A: Data integrity and digitalization are critical in ensuring that all testing processes are transparent, traceable, and compliant with regulatory standards, which is essential for maintaining market integrity[1].

Sources:

  1. The Business Research Company. Pharmaceutical Sterility Testing Global Market Report 2024.
  2. NBER Working Paper Series. The Unicorn Puzzle.
  3. IBISWorld. Pharmacies & Drug Stores in the US - Market Research Report.
  4. The Business Research Company. Sterile Compounding Pharmacies Global Market Report 2024.

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