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Last Updated: December 22, 2024

Sulfaphenazole - Generic Drug Details


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What are the generic drug sources for sulfaphenazole and what is the scope of patent protection?

Sulfaphenazole is the generic ingredient in one branded drug marketed by Pharm Res Assoc and Purdue Frederick, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for sulfaphenazole
US Patents:0
Tradenames:1
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 93
Patent Applications: 2,801
DailyMed Link:sulfaphenazole at DailyMed
Medical Subject Heading (MeSH) Categories for sulfaphenazole

US Patents and Regulatory Information for sulfaphenazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Res Assoc SULFABID sulfaphenazole SUSPENSION;ORAL 013093-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Purdue Frederick SULFABID sulfaphenazole TABLET;ORAL 013092-002 Approved Prior to Jan 1, 1982 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

Sulfaphenazole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sulfaphenazole

Introduction

Sulfaphenazole, a potent inhibitor of the cytochrome P450 enzyme CYP2C9, plays a significant role in the pharmacological landscape, particularly in the metabolism of various therapeutic agents. Understanding the market dynamics and financial trajectory of sulfaphenazole involves examining its clinical significance, market competition, and the economic factors influencing its development and pricing.

Clinical Significance of Sulfaphenazole

Sulfaphenazole is a strong and competitive inhibitor of CYP2C9, an enzyme crucial for the metabolic clearance of drugs such as oral anticoagulants, nonsteroidal anti-inflammatories, and oral hypoglycemics. Its inhibition of CYP2C9 can significantly impact the pharmacokinetics and pharmacodynamics of these drugs, leading to potential adverse drug reactions[1].

Market Competition in the Enzyme Inhibitor Space

The market for enzyme inhibitors, particularly those targeting the cytochrome P450 family, is competitive and influenced by several factors, including the specificity of the inhibitor, its potency, and the range of therapeutic applications. Sulfaphenazole's specificity for CYP2C9 sets it apart from other inhibitors, but it must compete with other compounds that may offer broader or more targeted inhibition profiles[1].

Economic Factors in Drug Development

The development of drugs like sulfaphenazole is heavily influenced by economic considerations. The high fixed costs of research and development, coupled with the need for significant investment in clinical trials and regulatory approvals, make the development process costly. For drugs targeting smaller patient populations, the economic viability is often questionable due to the limited market size and potential for generic competition[3].

Pricing Strategies

The pricing of sulfaphenazole and similar drugs is complex and influenced by several factors, including the cost of development, market demand, and regulatory environments. For drugs targeting small patient populations, firms often adopt high pricing strategies to justify the significant investment in research and development. However, this can lead to limited accessibility and regulatory scrutiny[3].

Impact of Precision Medicines

The shift towards precision medicines, which target specific genetic mutations or small patient populations, has significant economic implications. Drugs like sulfaphenazole, which could be part of precision medicine strategies due to their specific enzyme inhibition, may benefit from this trend. However, the lack of generic competition in these niche markets can lead to sustained high prices and limited market entry for new competitors[3].

Regulatory Considerations

Regulatory approvals and compliance play a critical role in the financial trajectory of any drug. For sulfaphenazole, ensuring compliance with regulatory standards, particularly in its use as a research tool or potential therapeutic agent, is essential. Any regulatory hurdles or changes in guidelines can significantly impact its market viability and financial performance[2].

Market Size and Demand

The market size for sulfaphenazole is influenced by its specific use cases, primarily in research settings and potentially in clinical applications where CYP2C9 inhibition is beneficial. The demand is driven by the need for precise enzyme inhibition in various therapeutic areas, which can be limited but highly specific. This niche demand can result in a stable but not necessarily expansive market[1].

Competitive Landscape

The competitive landscape for sulfaphenazole includes other CYP2C9 inhibitors and drugs that may offer similar or broader enzymatic inhibition. The specificity and potency of sulfaphenazole make it a valuable tool in research and clinical settings, but it must compete with other compounds that may offer advantages in terms of safety, efficacy, or cost[1].

Financial Projections

Financial projections for sulfaphenazole are tied to its research and clinical applications. As a research tool, it generates revenue through sales to academic and pharmaceutical research institutions. In clinical settings, its use could expand its revenue base, but this would depend on its approval and adoption as a therapeutic agent. The financial trajectory is likely to be stable with potential for growth if it gains wider clinical acceptance.

Case Studies: Similar Drugs

Drugs like Kalydeco (ivacaftor), which target small patient populations with specific genetic mutations, illustrate the financial dynamics of niche market drugs. Despite high prices, these drugs can generate significant revenue due to the lack of generic competition and the high value they provide to patients with rare conditions. Sulfaphenazole, if positioned similarly, could benefit from such a market strategy[3].

Future Outlook

The future outlook for sulfaphenazole is promising, particularly as research continues to uncover its potential therapeutic applications. As the pharmaceutical industry shifts towards precision medicines, drugs with specific enzymatic inhibition profiles like sulfaphenazole are likely to see increased demand. However, this will depend on ongoing research, regulatory approvals, and market acceptance.

Key Takeaways

  • Clinical Significance: Sulfaphenazole is a potent inhibitor of CYP2C9, impacting the metabolism of various therapeutic agents.
  • Market Competition: The market is competitive, with sulfaphenazole competing against other enzyme inhibitors.
  • Economic Factors: High development costs and limited market size influence its economic viability.
  • Pricing Strategies: High pricing strategies are common for niche market drugs to justify development costs.
  • Regulatory Considerations: Compliance with regulatory standards is crucial for market viability.
  • Market Size and Demand: Demand is driven by specific research and clinical needs.
  • Financial Projections: Revenue is generated through research and potential clinical applications.

FAQs

What is sulfaphenazole used for?

Sulfaphenazole is used as a strong and competitive inhibitor of the cytochrome P450 enzyme CYP2C9, primarily in research settings and potentially in clinical applications.

How does sulfaphenazole affect drug metabolism?

Sulfaphenazole inhibits CYP2C9, which is involved in the metabolic clearance of various therapeutic agents such as oral anticoagulants, nonsteroidal anti-inflammatories, and oral hypoglycemics.

What are the economic implications of developing drugs like sulfaphenazole?

The development of drugs like sulfaphenazole is costly due to high fixed costs of research and development. The economic viability is often questionable for drugs targeting small patient populations.

How does the shift towards precision medicines impact sulfaphenazole?

The shift towards precision medicines can increase demand for drugs like sulfaphenazole, which offer specific enzymatic inhibition. However, this can also lead to sustained high prices due to limited generic competition.

What regulatory considerations are important for sulfaphenazole?

Ensuring compliance with regulatory standards is critical for the market viability of sulfaphenazole. Any regulatory changes or hurdles can significantly impact its financial performance.

Sources

  1. APExBIO: Sulfaphenazole, CYP2C9 inhibitor, CAS# 526-08-9.
  2. FDA: APPLICATION NUMBER: 211964Orig1s000 INTEGRATED REVIEW.
  3. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  4. ScienceDirect: Sulfaphenazole - an overview.
  5. MDPI: Differing Membrane Interactions of Two Highly Similar Drug Molecules.

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