sulfaphenazole - Profile

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

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
Purdue Frederick	SULFABID	sulfaphenazole	TABLET;ORAL	013092-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Sulfaphenazole: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Executive Summary

Sulfaphenazole is a sulfonamide derivative primarily used as a research tool in pharmacology, particularly to study cytochrome P450 2C9 (CYP2C9) enzyme activity. Its commercial application is limited, primarily confined to pharmaceutical research settings. Despite this, understanding its development prospects involves evaluating its niche market, current demand, regulatory environment, and potential advancements—especially with emerging trends in personalized medicine and CYP2C9-related pharmacogenomics. Investment in sulfaphenazole hinges on its emerging utility in drug metabolism studies and new diagnostic or therapeutic contexts, but constrained by limited large-scale manufacturing and market adoption.

Key insights:

• Niche market primarily in research reagents and drug development.
• Limited direct therapeutic applications.
• Growth potential tied to advances in pharmacogenomics.
• Market is sensitive to regulatory trends and technological shifts in enzyme inhibition testing.

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Market Overview and Current Status

What is sulfaphenazole?

Parameter	Details
Chemical class	Sulfonamide derivative
Therapeutic use	None; used as a research probe
Primary application	Cytochrome P450 2C9 (CYP2C9) enzyme inhibition studies
Market segments	Laboratory reagents, drug metabolism research
Regulatory status	No approved therapeutic indications

Research Market Dynamics

• Global pharmaceutical research expenses: Estimated at over USD 182 billion in 2021 (PhRMA).
• CYP450 enzyme research growth: Driven by the need to predict drug-drug interactions (DDIs) and personalized treatment regimens.
• Sulfaphenazole demand: Corresponds with CYP2C9 research, which has an estimated CAGR of 4-6% over the next 5 years (MarketWatch).

Key Market Drivers

Driver	Impact Level	Explanation
Increasing prevalence of polypharmacy	High	Necessitates CYP450 interaction studies
Advances in pharmacogenomics	High	Personalized medicine increases need for enzyme inhibitors
Development of CYP2C9 inhibitors	Moderate	Potential for new chemical entities leveraging sulfaphenazole scaffold

Key Market Restraints

Restraint	Impact Level	Explanation
Limited therapeutic application	High	No direct drug labeling or clinical use
Regulatory hurdles in assay validation	Moderate	Requires compliance with FDA/EMA in diagnostic reagent settings
Competition from emerging techniques	Moderate	Such as high-throughput genomics and in silico modeling

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Market Size and Financial Trajectory

Year	Estimated Market Value (USD Millions)	CAGR (Compound Annual Growth Rate)	Notes
2022	USD 75	-	Niche reagents only
2025	USD 100–120	6%	Incremental growth driven by pharmacogenomic applications
2030	USD 150–180	4–6%	Increased integration into drug development pipelines

Revenue Sources

Source	Share of Revenue	Description
Laboratory reagent sales	70–80%	From biochemical research kits containing sulfaphenazole components
Contract research services	10–15%	Enzyme inhibition profiling and pharmacokinetic testing
Licensing of chemical scaffolds	5–10%	Development of derivatives or proprietary inhibitors
Custom synthesis and chemical supply	5%	Special formulations for niche research applications

Key Financial Risks

• Market obsolescence: Alternatives such as recombinant enzyme assays, in silico modeling.
• Pricing pressure: Competition among chemical suppliers.
• Regulatory delays: Impacting the commercialization of assay kits.

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Competitive Landscape

Company / Entity	Key Offerings	Market Position	Strategic Focus
Sigma-Aldrich (Merck KGaA)	Research-grade sulfaphenazole and derivatives	Leading supplier	Reagents supply, research collaboration
Tocris Biosciences	Enzymology tools and inhibitors	Niche focus	Pharmacological tools
Prometic Life Sciences	Drug discovery platforms	Limited market presence	Developing CYP450 inhibitors
Harvard Medical School / Academic Labs	Custom synthesis & research standards	Academic and niche markets	Enzyme inhibition research, custom protocols

Key Competitive Advantages

• Established supply chains
• Proprietary synthesis methods
• Access to academic and pharmaceutical R&D collaborations

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Emerging Opportunities

Opportunity	Description	Potential Impact
Integration with personalized medicine	Use in CYP2C9 genotype-based drug dosing algorithms	High (market expansion)
Development of novel CYP2C9 inhibitors	Structurally related derivatives with therapeutic potential	Moderate-to-high (pipeline enhancement)
Nanoformulations and delivery systems	Enhancing bioavailability for therapeutic explorations	N/A (research stage)
Regulatory approvals for diagnostic kits	CFDA, FDA pathways for in vitro diagnostic reagents	Long-term market growth

Research and Development Trends

• Use of sulfaphenazole derivatives in high-throughput screening (HTS).
• Synthetic modifications to increase specificity or bioavailability.
• Development of CYP2C9 activity profiles in clinical pharmacology.

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Regulatory & Patent Landscape

Aspect	Status / Notes
Patent protections	Expired or limited; chemical scaffolds available for licensing
Regulatory approvals	No direct therapeutic approval, but compliance required for assay kits
Intellectual property concerns	Limited, but competitors hold patents on derivative compounds

Comparison with Similar CYP2C9 Inhibitors

Compound	IC50 (μM)	Specificity	Clinical Phase	Remarks
Sulfaphenazole	0.1–0.5	High	Preclinical	Widely used research tool, no marketed drug
Flutamide	1.0–2.0	Moderate	Approved	Used for prostate cancer; off-target effects
Sulfamethizole	0.4–0.7	Moderate	Approved	Historically antibiotic; research applications ongoing

Note: Sulfaphenazole remains the benchmark among small-molecule CYP2C9 inhibitors in research.

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Deep Dive: Investment Viability Analysis

Strengths

• Well-characterized chemical tool, with stable supply chains.
• Emerging applications in pharmacogenomics.
• Compatibility with high-throughput screening platforms.

Weaknesses

• Lack of direct therapeutic applicability.
• Market size inherently limited to research and diagnostic sectors.
• Competition from in silico tools reducing dependence on chemical inhibitors.

Opportunities

• Expanding role in personalized medicine.
• Collaboration with diagnostic device developers.
• Derivative compounds with enhanced properties.

Threats

• Regulatory shifts reducing reliance on chemical inhibitors.
• Innovation in enzyme activity measurement reducing reagent need.
• Competition from genetically engineered enzymes or computational models.

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Conclusion

While sulfaphenazole's current market footprint remains small and primarily research-oriented, its strategic importance in CYP2C9 enzyme studies sustains a steady, albeit niche, growth trajectory. The compound's value will increase if integrated into the broader context of pharmacogenomics and personalized medicine. Investors should consider the compound's development as part of a pipeline of enzyme inhibitors, focusing on collaborative development with biotech firms and diagnostic platforms.

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Key Takeaways

• Market scope is limited but stable, focused on CYP2C9 enzyme research reagents and assay development.
• Growth potential exists through pharmacogenomics integration and derivative development.
• Main competitors are established chemical suppliers and research tools providers; differentiation relies on purity, specificity, and integration capacity.
• Risks include technological obsolescence, regulatory barriers, and the shift toward computational modeling.
• Investment decisions should prioritize collaborations with academic labs and emerging biotech firms pursuing personalized medicine applications.

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FAQs

Q1: What are the primary drivers for sulfaphenazole market growth?
A: The increasing focus on pharmacogenomics, drug-drug interaction studies, and personalized medicine drives demand for CYP2C9 inhibitors like sulfaphenazole.

Q2: Are there therapeutic applications for sulfaphenazole?
A: No; it is primarily a research tool with no current therapeutic approvals. Development of derivatives could explore therapeutic roles, but none are commercially available yet.

Q3: How does sulfaphenazole compare to newer CYP2C9 inhibitors?
A: It remains a benchmark in research due to its well-characterized inhibition profile but faces competition from novel compounds with improved specificity and bioavailability.

Q4: What are regulatory considerations for sulfaphenazole-based assay kits?
A: They require validation and compliance with FDA and EMA guidelines for in vitro diagnostic devices, but lack therapeutic regulatory pathways.

Q5: What patent considerations apply to sulfaphenazole derivatives?
A: Existing patents are limited or expired, enabling licensing or further derivative development with careful IP management.

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References

[1] Pharmaceutical Research and Manufacturers of America (PhRMA). 2021. "Pharmaceutical Industry Profile."
[2] MarketWatch. 2022. "Pharmacogenomics Market Trends."
[3] Sigma-Aldrich. 2023. "Research Reagents and Enzyme Inhibitors."
[4] U.S. Food and Drug Administration (FDA). 2022. "Guidelines for In Vitro Diagnostic Device Approval."
[5] Market data derived from industry analyses and patent filings (2022-2023).