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Last Updated: March 26, 2026

SULFAPHENAZOLE - Generic Drug Details


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What are the generic sources for sulfaphenazole and what is the scope of freedom to operate?

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
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Purdue Frederick SULFABID sulfaphenazole TABLET;ORAL 013092-002 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

SULFAPHENAZOLE Market Analysis and Financial Projection

Last updated: February 15, 2026

What are the current market dynamics for sulfaphenazole?

Sulfaphenazole is a sulfonamide antibiotic primarily used as a research tool rather than a marketed pharmaceutical for widespread clinical use. Its applications focus on enzyme inhibition studies, notably involving cytochrome P450 enzymes, rather than direct therapeutic indications.

The drug's market relevance stems from its role in research and diagnostic applications within pharmacology. It is not approved by regulatory agencies such as the FDA or EMA for medicinal use, limiting its commercial market to research institutions, biotech firms, and pharmaceutical R&D departments.

Key factors shaping the market dynamics include:

  • Limited Clinical Use: No recent approvals for human or veterinary medicine, constraining the scope of commercialization.
  • Research Utility: Heavy reliance on sulfaphenazole in academic and preclinical research drives demand. However, this demand is generally limited by funding trends and research priorities.
  • Alternative Compounds: Emergence of newer, more selective enzyme inhibitors diminishes sulfaphenazole's relevance in experimental settings.
  • Intellectual Property: Lack of patent protection on many analytical forms, leading to increased generic availability and market saturation among research chemicals.

How does sulfaphenazole's financial trajectory look in the pharmaceutical context?

The financial outlook for sulfaphenazole is constrained because it does not function as a marketed therapeutic agent. Instead, revenues derive from chemical suppliers and research laboratories purchasing standard or custom-synthesized compounds.

Revenue streams include:

  • Selling to chemical suppliers who distribute to research institutions.
  • Direct sales to academic labs and biotech companies conducting enzyme inhibition assays.

No significant licensing, patent, or exclusive manufacturing agreements exist for sulfaphenazole, limiting revenue potential.

Market size estimations:

  • The global chemical research reagents market was valued at approximately $7 billion in 2021.
  • Sulfaphenazole accounts for a fraction of this, as a niche research chemical.
  • Estimated annual sales volume for sulfaphenazole globally ranges in the low tens of kilograms, translating into low single-digit millions of USD annually.

Pricing structure:

  • Cost ranges from $50 to $200 per gram, depending on purity, quantity, and supplier.
  • Lack of patent protection entails competitive pricing, with multiple generic suppliers.

Future perspectives:

  • No scheduled new formulations or derivative development projects targeting sulfaphenazole appear publicly planned.
  • The compound's role in enzyme inhibition research suggests stability in niche applications but limited growth prospects unless new applications surface.

How do regulatory policies affect the sulfaphenazole market?

Sulfaphenazole's status as an off-patent research chemical means regulation impacts licensing and distribution more than direct sales.

  • Regulations: Research chemical classification limits government oversight but emphasizes safety and handling protocols.
  • Import/Export controls: Subject to chemical safety legislation in importing/exporting countries.
  • Intellectual property restrictions: Minimal, increasing availability but reducing commercial exclusivity.

What are the competitive considerations?

The market faces competition mainly from compounds like:

  • Sulfaphenazole analogs with improved selectivity.
  • Other enzyme inhibitors for cytochrome P450 studies such as ketoconazole or fluconazole.
  • Proprietary compounds developed for specific research needs.

Commercial suppliers often bundle sulfaphenazole with related research chemicals, but prices are driven by competing generic suppliers with similar formulations, increasing price sensitivity.

Summary of market figures

Aspect Detail
Market size (total) Estimated <$10 million globally
Annual sales volume Tens of kilograms
Price per gram $50–$200
Major buyers Research institutions, biotech firms
Patent status No patents; off-patent
Regulatory status Research chemical classification

Key Takeaways

  • Sulfaphenazole's market centers on research use, with limited therapeutic or commercial application.
  • Revenue generated from chemical sales remains modest, with no significant licensing or patent-driven income.
  • Market stability depends on ongoing research needs, with competition arising from newer compounds and analogs.
  • Changes in research trends and funding could influence demand.
  • Regulatory policies focus on safety rather than market authorization, as it remains a research chemical.

FAQs

1. Is sulfaphenazole approved for clinical therapy? No, it is used solely as a research tool and has no regulatory approval for therapeutic use.

2. Who are the main suppliers of sulfaphenazole? Multiple chemical suppliers offer sulfaphenazole, including Sigma-Aldrich and TCI, typically as research-grade chemical.

3. Can sulfaphenazole be used in drug development? It is used in enzyme inhibition assays to understand cytochrome P450 interactions but is not a drug candidate itself.

4. What are the regulatory restrictions on sulfaphenazole? It is classified as a research chemical with standard safety guidelines; no special licensing is typically required for research use.

5. Are there any new derivatives or analogs of sulfaphenazole in development? Currently, no publicly available data indicates ongoing development of sulfaphenazole derivatives with clinical or commercial promise.


Citations

[1] MarketResearch.com, "Global Chemical Reagents Market," 2021.
[2] Patents and Chemical Suppliers Databases.
[3] Regulatory agencies; FDA and EMA status reports.

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