Last Updated: June 24, 2026

Sulfanilamide - Generic Drug Details


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

Sulfanilamide is the generic ingredient in two branded drugs marketed by Pharmobedient and Cosette, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for sulfanilamide.

Summary for sulfanilamide
Recent Clinical Trials for sulfanilamide

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SponsorPhase
Tongji HospitalPHASE4
Peking University First HospitalPhase 4
Beijing Chao Yang HospitalPhase 4

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US Patents and Regulatory Information for sulfanilamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmobedient AVC sulfanilamide SUPPOSITORY;VAGINAL 006530-004 Jan 27, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Cosette SULFANILAMIDE sulfanilamide CREAM;VAGINAL 088718-001 Sep 19, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient AVC sulfanilamide CREAM;VAGINAL 006530-003 Jan 27, 1987 DISCN Yes 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

Sulf(i)nilamide Market Dynamics and Financial Trajectory (US and Global)

Last updated: June 14, 2026

Sulf(an)ilamide is an early sulfonamide antibacterial with limited modern commercial footprint. Market dynamics are dominated by historical substitution by newer sulfonamides and non-sulfonamide antibiotics, tightly constrained current use, and regulatory-driven availability across geographies. Financial trajectory is structurally declining outside niche markets and is primarily determined by legacy supply, drug-quality/regulatory status, and whether any local jurisdictions still permit marketed products.

Is sulf(an)ilamide still commercially sold and where is it available?

Featured snippet: Current commercial availability is uneven and largely legacy. In many jurisdictions, sulf(an)ilamide has either been discontinued or displaced by broader-spectrum, lower-toxicity antibiotics.

Which countries show ongoing market presence?

Sulf(an)ilamide availability is typically fragmented:

  • United States: broadly considered obsolete in practice for systemic bacterial infections, with limited or no meaningful contemporary market share. Any presence is usually tied to legacy formulations, specialty supply, or discontinued/limited product lines.
  • Europe and UK: generally displaced by later-generation sulfonamides and other antibiotic classes; remaining access is often historical/limited.
  • Developing markets: occasional continued use can persist where newer antibiotic access is limited, but the base is not comparable to modern blockbuster demand.

What dosage forms and strengths are most likely to persist?

Legacy sulfonamide supply patterns typically concentrate in older:

  • Oral tablets/capsules
  • Topical or local formulations (where tolerated historically)
  • Compounded or small-batch supply (jurisdiction-dependent)

Why did sulf(an)ilamide lose market share versus later antibiotics?

Featured snippet: The competitive displacement is driven by safety and efficacy limits relative to successors and to modern antibiotic standards.

How did antibiotic substitution reshape demand?

Key dynamics:

  • Shift to newer sulfonamides and combinations: Later sulfonamides with improved dosing convenience and broader clinical utility reduced reliance on sulf(an)ilamide.
  • Emergence of non-sulfonamide antibiotics: Beta-lactams, macrolides, tetracyclines, and fluoroquinolones outcompeted older agents for many indications.
  • Rising antimicrobial stewardship constraints: Modern prescribing and resistance monitoring frameworks favor antibiotics with stronger contemporary evidence and predictable safety.

What safety profile issues affected long-term adoption?

While sulfonamides are a class, historical practice includes concerns such as:

  • Hypersensitivity reactions
  • Hematologic effects
  • Renal risks (class effect historically managed by hydration and monitoring) Over decades, these issues plus the introduction of safer alternatives reduced institutional use.

What drives sulf(an)ilamide pricing and gross margin today?

Featured snippet: Pricing is supply-constrained and volume-limited. Margins depend on regulatory compliance costs, small production runs, and channel liquidity.

What market structure exists for an obsolete antibiotic ingredient?

Typically:

  • Low-scale manufacturing with compliance overhead
  • Limited number of suppliers
  • Higher per-unit costs due to batch sizes and quality systems relative to modern high-volume drugs
  • Channel-driven pricing (distributor economics matter more when volumes are small)

How do input costs and formulation complexity impact cost of goods?

For older active ingredients:

  • API sourcing and purification quality requirements can increase COGS.
  • Some manufacturers maintain production primarily for regulatory filings, contract manufacturing, or small tender lanes.

What is the financial trajectory for sulf(an)ilamide: revenue, profitability, and demand trends?

Featured snippet: The long-run trajectory is downward outside niche channels; financial results track limited procurement rather than sustained broad retail demand.

How does demand usually evolve after clinical displacement?

After displacement by newer antibiotics:

  • demand decays from institutional formularies
  • procurement transitions to emergency or niche needs
  • volumes shrink, which raises unit costs
  • suppliers exit if filings or quality upgrades become uneconomical

What revenue drivers remain in a declining product?

  • Niche therapeutic use where newer options are constrained
  • Specialty pharmacy and compounded supply
  • Government or tender purchasing in lower-access segments
  • In-country generic equivalents if any remain registered

What financial outcomes are typical for legacy antibiotics?

Legacy products often show:

  • modest recurring revenue for remaining suppliers
  • higher relative gross margin volatility due to intermittent tender volumes
  • compressed promotional spend (marketing is usually limited)
  • elevated regulatory and compliance costs per unit

How do regulatory status and quality compliance affect the sulf(an)ilamide business?

Featured snippet: Regulatory clearance and ongoing manufacturing compliance determine whether sulf(an)ilamide can be sold at all, not competitive differentiation.

What FDA/EMA-style availability patterns typically apply?

For older antibiotics:

  • If a product is discontinued or not maintained on updated lists, practical market access can disappear.
  • If manufacturing sites or filings are not maintained, availability can become intermittent.

What quality events can influence supply continuity?

Common disruption vectors:

  • facility inspection outcomes
  • sterility/endotoxin testing for certain forms (if applicable)
  • stability requalification and shelf-life maintenance
  • changes in API supplier or polymorph control (if relevant)

Does sulf(an)ilamide face patent or exclusivity barriers today?

Featured snippet: As an early sulfonamide, sulf(an)ilamide itself is not a modern, protected IP asset in most jurisdictions; market access is typically supply and regulatory driven rather than patent driven.

How do IP dynamics usually look for first-generation antibiotics?

  • Original patents are long expired.
  • Modern “blocking” effects, if any, are more often tied to specific formulations, polymorphs, or manufacturing processes for a particular marketed product, not the underlying API.

What does that mean for market entry?

  • Competitive pressure is typically from generic supply rather than litigation.
  • Entry is constrained by regulatory filings and manufacturing qualification.

Is there any current patent estate for sulf(an)ilamide formulations or methods-of-use?

Featured snippet: Any remaining patent coverage is likely narrow and product-specific, not blanket API protection.

Where formulation patents typically appear for legacy actives

  • improved dissolution or stability
  • modified release
  • fixed-dose combinations
  • protective excipient systems
  • manufacturing process refinements

Why that still rarely creates blockbuster economics

Even with incremental patents:

  • total category demand is small for legacy antibiotics
  • payers are not incentivized for high-priced legacy therapy
  • physicians treat based on contemporary guidelines favoring other agents

What does litigation and Paragraph IV play look like for sulf(an)ilamide?

Featured snippet: Modern Paragraph IV litigation is unlikely to be a major driver because the API is not typically within active, enforceable exclusivity frameworks.

How does the absence of active exclusivity change competition?

  • Generic entry is more often a “file and supply” race than a Hatch-Waxman dispute.
  • Business risk concentrates in regulatory maintenance and quality, not courtroom outcomes.

How does sulf(an)ilamide compare with modern sulfonamides and antibiotic substitutes?

Featured snippet: Newer antibiotics have displaced sulf(an)ilamide on efficacy, safety, and clinical guideline fit.

What competitive set matters in practice?

  • later sulfonamide antibiotics (where clinically used historically)
  • beta-lactams (penicillins/cephalosporins)
  • macrolides (e.g., azithromycin)
  • tetracyclines
  • fluoroquinolones (where appropriate under stewardship rules) Sulf(an)ilamide’s practical “win” scenarios are niche and localized.

Where would sulf(an)ilamide still be considered?

  • constrained access settings
  • legacy-treatment protocols
  • specific sensitivity or susceptibility patterns where older sulfonamides still play a role In high-income formularies, it is generally not a primary choice.

What are the biggest risks to the sulf(an)ilamide revenue stream?

Featured snippet: The revenue base is fragile because demand is small, substitution is easy, and compliance costs are fixed.

Demand risks

  • additional displacement by new antibiotics or shifting stewardship guidelines
  • reduced tender purchasing or formulary removal
  • resistance shifts that reduce clinical utility

Supply risks

  • manufacturer exit due to compliance costs
  • API supply disruptions
  • batch failures or inspection outcomes that force suspension

Regulatory and pricing risks

  • withdrawal of outdated filings
  • pricing pressure from competing generics and alternative antibiotics
  • inability to maintain stability shelf-life and requalification

What business scenarios could stabilize or reverse sulf(an)ilamide performance?

Featured snippet: Stabilization depends on either niche institutional procurement or renewed localized demand, not mainstream clinical adoption.

Potential upside channels

  • government stock programs in specific regions
  • emergency procurement where newer agents are unavailable
  • development of a specific niche formulation that restores reliable access
  • partnerships with specialty distributors to improve channel continuity

What would be required to drive sustained growth

  • meaningful therapeutic modernization (new combination regimens with strong evidence)
  • credible regulatory maintenance with assured supply chain
  • differentiation by patient outcomes or safety at scale, which is difficult for a displaced legacy antibiotic

Key Takeaways

  • Sulf(an)ilamide’s market is legacy and fragmented, with demand concentrated in niche channels rather than mainstream prescribing.
  • Competitive displacement by later sulfonamides and non-sulfonamide antibiotics is the dominant driver of declining volumes.
  • Pricing and financial performance are supply-constrained: unit economics depend on compliance overhead and small batch production.
  • Patent and exclusivity barriers are unlikely to be the primary bottleneck; market access is more constrained by regulatory maintenance and manufacturing qualification than by IP.
  • The biggest threats are continued formulary/tender erosion and supplier exit risk; any stability would come from localized procurement or specialized formulations.

FAQs

  1. What therapeutic indications historically used sulf(an)ilamide still have residual demand today?
  2. How do antibiotic resistance patterns influence the residual market for older sulfonamides like sulf(an)ilamide?
  3. What quality and regulatory maintenance requirements most often cause supply interruption for legacy antibiotics?
  4. Could sulf(an)ilamide be repositioned as part of a fixed-dose combination to regain market relevance?
  5. How does the competitive landscape shift if newer antibiotics face shortages or supply constraints in certain geographies?

References

  1. (No sources were cited because no verifiable, drug-specific market, regulatory, or financial dataset for sulf(an)ilamide was provided in the prompt.)

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