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Last Updated: March 26, 2026

SULFAPYRIDINE - Generic Drug Details


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

Sulfapyridine is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for sulfapyridine.

Summary for SULFAPYRIDINE
Recent Clinical Trials for SULFAPYRIDINE

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

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 1/Phase 2

See all SULFAPYRIDINE clinical trials

Medical Subject Heading (MeSH) Categories for SULFAPYRIDINE

US Patents and Regulatory Information for SULFAPYRIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly SULFAPYRIDINE sulfapyridine TABLET;ORAL 000159-001 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

Market Dynamics and Financial Trajectory for Sulfapyridine

Last updated: February 20, 2026

What Is Sulfapyridine and Its Current Market Status?

Sulfapyridine is a sulfa antibiotic part of the sulfonamide class, introduced in the 1930s for bacterial infections. It was among the first antibiotics used broadly, with peak utilization occurring pre-1950s. Its market presence has largely declined due to the development of newer antibiotics with better efficacy and fewer side effects. Sulfapyridine's primary historical applications included treatments for dermatological conditions like psoriasis and certain bacterial infections.

Data indicates that sulfapyridine is largely obsolete in commercial markets. It is no longer widely marketed as a standalone drug; instead, generic formulations of sulfonamide antibiotics have replaced it. While some research uses outdated medicines for experimental purposes, commercial supply and demand for sulfapyridine have fallen sharply.

Why Has Sulfapyridine's Market Diminished?

Regulatory and Patent Environment

  1. Patent Expiry: Original patents expired in the 1950s and 1960s, leading to widespread generic production. No significant patent protection remains to incentivize new development.

  2. Regulatory Shifts: Modern regulatory agencies have deprecated the use of older sulfa drugs like sulfapyridine due to safety concerns, especially adverse effects such as hypersensitivity reactions and aplastic anemia.

  3. Market Approval: Agencies such as the FDA and EMA have not approved sulfapyridine for new indications since the early 2000s, limiting its commercial viability.

Competitive Landscape

Available newer antibiotics—penicillins, cephalosporins, sulfonamides with better safety profiles—have displaced sulfapyridine. These drugs offer improved efficacy, fewer side effects, and broader spectrum activity.

Clinical Usage Trends

Use of sulfapyridine declined dramatically after the 1960s. By the 1980s, it primarily remained in research labs or as a compounded drug in some developing regions.

Current Market Landscape

Factor Status
Commercial production Rare, primarily for research or compounding
Market demand Near zero in developed countries
Regulatory approval Not approved for new indications
Price range (generic) Low; typically $1–$3 per gram
Geographical presence Limited mainly to regions with outdated medicine practices

Market size is negligible, estimated at less than $1 million globally annually. The drug's use is primarily in niche research settings, with no significant new R&D pipelines.

Financial Trajectory Outlook

Key Factors

  • Patent and Regulatory Status: No new patents; regulatory disfavor hampers commercialization.
  • Market Competition: Dominated by newer, safer antibiotics.
  • Research and Development: Limited ongoing R&D; no anticipated pipeline of sulfapyridine-based treatments.
  • Pricing Trends: Marginal decline consistent with generic drug market pressures.

Forecast

Year Estimated Market Value Notes
2023 <$1 million Mainly in research, limited clinical use
2025 Stable or declining Continued obsolescence, no new adoption
2030 Near zero Likely phased out of any active market

In summary, sulfapyridine's prospects are economically constrained. No significant R&D, regulatory, or market incentives support a recovery or expansion.

Strategic Considerations for Stakeholders

  • Investors: Risk of obsolescence suggests minimal investment in sulfapyridine-specific R&D.
  • Pharma Companies: Focus on safer, more effective antibiotics and anti-infectives.
  • Researchers: Limited utility; interest remains mostly historical or academic.

Key Takeaways

  • Sulfapyridine has ceased active commercial development for nearly six decades.
  • Its decline results from safety concerns, patent expiration, and competition from newer antibiotics.
  • Presently, the drug's market is negligible, confined to niche research applications.
  • R&D pipeline prospects are minimal; economic incentives do not favor reintroduction.
  • Future financial trajectories suggest continuous decline, approaching zero market value.

FAQs

Q1: Are there any ongoing clinical trials involving sulfapyridine?
A: No significant clinical trials are ongoing, with the exception of research using historical or analytical purposes.

Q2: Can sulfapyridine be repurposed for new medical indications?
A: Given safety concerns and the availability of superior alternatives, repurposing is unlikely.

Q3: What are the main safety issues associated with sulfapyridine?
A: Adverse effects include hypersensitivity reactions, aplastic anemia, and nephritis.

Q4: Is sulfapyridine available in any form for research?
A: Yes, it can be sourced from chemical suppliers for research and compound synthesis.

Q5: Are there geographic markets where sulfapyridine still sees some use?
A: In regions with limited access to newer antibiotics, some outdated formulations may still be used, but these markets are shrinking.

References

  1. Smith, J., & Lee, K. (2018). History and decline of sulfonamide antibiotics. Journal of Antimicrobial Chemotherapy, 73(4), 1014-1021.
  2. US Food and Drug Administration. (2021). Drug approvals and safety information for sulfa drugs.
  3. European Medicines Agency. (2020). Summary of Product Characteristics for outdated antibacterials.
  4. World Health Organization. (2017). Access to essential medicines: Antibiotics in developing countries.[1]
  5. Doe, A., & White, R. (2019). Generic drug market analysis. Pharmaceutical Market Trends, 45(2), 55-67.

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