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Last Updated: December 23, 2024

GLOFIL-125 Drug Patent Profile


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Which patents cover Glofil-125, and when can generic versions of Glofil-125 launch?

Glofil-125 is a drug marketed by Isotex and is included in one NDA.

The generic ingredient in GLOFIL-125 is iothalamate sodium i-125. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iothalamate sodium i-125 profile page.

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Summary for GLOFIL-125
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 6
Clinical Trials: 1
Patent Applications: 4
What excipients (inactive ingredients) are in GLOFIL-125?GLOFIL-125 excipients list
DailyMed Link:GLOFIL-125 at DailyMed
Drug patent expirations by year for GLOFIL-125
Recent Clinical Trials for GLOFIL-125

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado, DenverPhase 4

See all GLOFIL-125 clinical trials

Pharmacology for GLOFIL-125

US Patents and Regulatory Information for GLOFIL-125

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Isotex GLOFIL-125 iothalamate sodium i-125 INJECTABLE;INJECTION 017279-001 Approved Prior to Jan 1, 1982 RX 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

GLOFIL-125 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GLOFIL-125

Introduction

GLOFIL-125, or Sodium Iothalamate I-125 Injection, is a diagnostic agent used to evaluate glomerular filtration in patients with renal disease. To understand its market dynamics and financial trajectory, it is essential to delve into various aspects including its clinical use, market competition, and the financial performance of the companies involved in its production and distribution.

Clinical Use and Indications

GLOFIL-125 is indicated for the evaluation of glomerular filtration, which is crucial in diagnosing and monitoring renal disease. The compound is cleared by glomerular filtration without tubular secretion or reabsorption, making it an effective tool for assessing renal function[4].

Market Competition

The market for diagnostic agents like GLOFIL-125 is relatively niche but competitive. Companies operating in this space often focus on acquiring and marketing products that have specific clinical uses and can benefit from targeted sales and marketing efforts. For instance, Mallinckrodt Pharmaceuticals, which has been involved in the acquisition and marketing of various pharmaceutical products, including diagnostic agents, has a strategy to focus on high-prescribing specialty physicians to drive sales[1].

Target Market and Sales Strategy

The target market for GLOFIL-125 includes nephrologists and other healthcare professionals involved in the diagnosis and management of renal diseases. Effective sales strategies involve promoting the product to these high-prescribing specialty physicians through a nationwide sales and marketing organization. This approach is similar to how other specialty pharmaceutical companies, like Questcor Pharmaceuticals, have targeted their marketing efforts towards specific medical specialties to increase product sales[2].

Financial Performance

The financial performance of GLOFIL-125 is tied to the overall financial health of the company that markets and distributes it. For example, if we look at the financial reports of Questcor Pharmaceuticals, which was another company operating in the specialty pharmaceutical space, we see that net product sales can fluctuate based on various factors such as changes in demand, pricing strategies, and competition. In the case of Questcor, net product sales decreased in the first quarter of 2003 due to factors like advance buying by wholesalers and a decrease in demand for certain products[2].

Revenue and Sales Trends

  • Revenue Fluctuations: The revenue generated by GLOFIL-125 can fluctuate based on market demand and competition. For instance, if there is a decrease in the incidence of renal diseases or if alternative diagnostic agents become more popular, sales of GLOFIL-125 could decline.
  • Pricing Strategies: Companies may implement price increases to offset potential decreases in demand. For example, Questcor implemented a 13% price increase for Ethamolin to counteract declining demand[2].

Cost Structure and Profitability

  • Manufacturing and Distribution Costs: The cost of manufacturing and distributing GLOFIL-125 can impact its profitability. Changes in manufacturing arrangements, such as the transfer from one manufacturer to another, can result in higher unit costs and decreased gross margins[1].
  • Research and Development: Companies involved in the production of diagnostic agents like GLOFIL-125 typically have minimal spending on research and development, focusing instead on marketing and sales efforts to drive revenue growth[1].

Market Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of pharmaceutical products. Changes in regulations or reimbursement policies can affect the demand and profitability of diagnostic agents like GLOFIL-125.

Consumer and Healthcare Trends

The consumerization of healthcare, particularly in areas like obesity treatment, highlights a broader trend where patients are increasingly taking a more active role in their healthcare decisions. While this trend is more pronounced in therapeutic areas like obesity, it underscores the importance of patient-centric marketing strategies for all pharmaceutical products, including diagnostic agents[3].

Financial Projections and Future Outlook

Market Growth Potential

The market for diagnostic agents is expected to grow as the prevalence of renal diseases increases. Effective marketing and sales strategies, along with strategic acquisitions and licensing agreements, can position companies to capitalize on this growth.

Challenges and Mitigation Strategies

  • Competition: The presence of alternative diagnostic agents poses a competitive challenge. Companies must continuously evaluate and improve their products to maintain market share.
  • Regulatory Changes: Adapting to changes in regulatory and reimbursement policies is crucial for maintaining profitability.

Key Takeaways

  • Targeted Marketing: Effective sales strategies involve targeting high-prescribing specialty physicians.
  • Financial Fluctuations: Revenue and profitability can fluctuate based on demand, competition, and manufacturing costs.
  • Regulatory and Market Trends: Companies must be adept at navigating regulatory changes and consumer trends to maintain market position.
  • Cost Management: Managing manufacturing and distribution costs is critical for maintaining profitability.

FAQs

What is GLOFIL-125 used for?

GLOFIL-125 is used for the evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.

How does the market competition affect GLOFIL-125 sales?

Market competition from other diagnostic agents can impact sales, but targeted marketing efforts towards high-prescribing specialty physicians can help maintain market share.

What are the key financial challenges for companies marketing GLOFIL-125?

Key financial challenges include managing manufacturing and distribution costs, adapting to changes in demand and competition, and navigating regulatory and reimbursement policies.

How does the regulatory environment impact GLOFIL-125?

Changes in regulations or reimbursement policies can significantly affect the demand and profitability of GLOFIL-125.

What is the future outlook for GLOFIL-125 in the market?

The future outlook is positive due to the growing need for diagnostic agents in renal disease management, but companies must remain adaptable to market and regulatory changes.

Cited Sources

  1. Mallinckrodt Pharmaceuticals Investor Relations - "Untitled" [PDF]
  2. Questcor Pharmaceuticals, Inc. - "Questcor Pharmaceuticals, Inc. - Investor Relations" [PDF]
  3. Stifel - "Obesity Market Review - July 8, 2024" [PDF]
  4. Drugs.com - "Glofil-125: Package Insert / Prescribing Information"

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