Last Updated: June 17, 2026

SULFALAR Drug Patent Profile


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Which patents cover Sulfalar, and what generic alternatives are available?

Sulfalar is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in SULFALAR is sulfisoxazole. There are three drug master file entries for this compound. Additional details are available on the sulfisoxazole profile page.

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Summary for SULFALAR
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 125
DailyMed Link:SULFALAR at DailyMed

US Patents and Regulatory Information for SULFALAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis SULFALAR sulfisoxazole TABLET;ORAL 084955-001 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 SULFALAR

Last updated: February 14, 2026

Overview

Sulfalar (generic name: sulfaguanidine) is an antibacterial agent primarily used in veterinary medicine. It belongs to the sulfonamide class, which inhibits bacterial dihydropteroate synthase. The drug's market presence is limited to animal health and is not approved for human use. Its financial performance hinges on livestock health demand, regulatory climates, and competitive sulfonamide markets.

Market Demand Drivers

  • Livestock Industry Growth: Increasing global livestock populations, notably in emerging markets like Southeast Asia, drive demand for veterinary antibacterials.

  • Antibiotic Resistance Concerns: Regulatory restrictions on antibiotic use in animals influence market dynamics. Sulfalar's use remains permitted in regions with less stringent antibiotic policies, such as certain parts of Asia and Africa.

  • Regulatory Environment: The US FDA's Veterinary Feed Directive (VFD) and European Medicines Agency (EMA) guidelines restrict certain antimicrobials to prevent resistance. Sulfaguanidine's status varies, impacting market access.

  • Competing Products: The market for veterinary sulfonamides includes older drugs like sulfadimidine and newer antibiotics (e.g., fluoroquinolones). Profitability depends on regulatory approval, efficacy, safety profile, and cost.

Market Size & Revenue Estimates

  • The veterinary antimicrobial market was valued at approximately USD 1.4 billion in 2021. Sulfaguanidine forms a niche segment, estimated at less than USD 50 million globally, predominantly in Asia.

  • Regional Breakdown: Asia Pacific accounts for over 60% of sulfaguanidine's utilization, driven by livestock density and regulatory leniency. North America and Europe show minimal or no market share due to regulatory restrictions.

  • Profit Margins: Pricing varies considerably, with retail prices for veterinary sulfonamides ranging from USD 0.10 to USD 0.50 per dose, depending on formulation and region.

Regulatory and Patent Landscape

  • No current patents protect sulfalar exclusively; most formulations are off-patent, leading to generic manufacturing.

  • Regulatory approval status varies regionally: Approved in some Asian countries, restricted or unapproved elsewhere.

  • Recent anti-microbial stewardship initiatives influence approval trajectories, potentially limiting market expansion.

Competitive Environment

Competitors Market Share Key Strengths Key Limitations
Generic sulfaguanidine formulations Dominant in Asia Cost-effective, well-established Limited regulatory approval in the West
Other sulfonamides (sulfadimidine, sulfadiazine) Moderate Broader international approval Higher cost, resistance concerns
Newer antibiotics (e.g., enrofloxacin) Small niche Spectrum of activity Higher price, regulatory restrictions

Financial Projections

  • Short Term (1-2 Years): Stable revenues within niche markets, limited growth due to regulatory pressures and microbial resistance issues.

  • Medium Term (3-5 Years): Potential for regional market expansion if regulatory approvals are obtained or maintained; increased emphasis on disease control in emerging markets.

  • Long Term (5+ Years): Market contraction likely if global trends favor vaccines over antimicrobials or if resistance leads to bans. Conversely, developing combined therapies with lower resistance potential can sustain utility.

Risks and Opportunities

Risks include regulatory restrictions, resistance development, and competition from newer, prescription-only antibiotics. Opportunities arise from expansion into underdeveloped markets, product line diversification, and development of formulations with improved safety profiles.


Key Takeaways

  • Sulfalar's market exists mainly within Asia Pacific's veterinary sector and depends heavily on livestock industry growth and regional regulations.

  • Revenue estimates remain below USD 50 million globally, with stable short-term outlooks.

  • Regulatory changes aimed at antimicrobial resistance may constrain future markets but could open niches for optimized formulations.

  • Competition from newer antibiotics and generics poses ongoing market challenges.

  • Long-term prospects rely on regulatory compliance, geographic expansion, and potential formulation innovations.


FAQs

  1. What are the main regions where sulfalar is used?
    Primarily in Asia Pacific countries like India, China, and Southeast Asian nations, where livestock markets are sizable, and regulatory oversight is moderate.

  2. Is sulfalar approved for use in humans?
    No. Sulfaguanidine-based drugs are not approved for human use and are restricted mainly to veterinary applications.

  3. How does antimicrobial resistance impact sulfalar's market?
    Resistance development diminishes efficacy, leading to regulatory restrictions and reduced utilization, especially in regions with strict antimicrobial stewardship.

  4. What are alternatives to sulfalar in veterinary medicine?
    Alternatives include other sulfonamides, fluoroquinolones, and macrolides, though their use depends on regional approvals and resistance profiles.

  5. What are potential growth avenues for sulfalar?
    Expansion into underpenetrated markets, formulation improvements, and combination therapies may sustain or slightly grow its market presence.


Citations

[1] Market data sourced from IBISWorld and Allied Market Research reports.
[2] Regulatory environment details from FDA and EMA guidelines.
[3] Competitive landscape and regional market analysis based on industry reports and market surveys.

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