Last Updated: May 11, 2026

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL Drug Patent Profile


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When do Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl patents expire, and when can generic versions of Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl launch?

Erythromycin Ethylsuccinate And Sulfisoxazole Acetyl is a drug marketed by Barr and is included in one NDA.

The generic ingredient in ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL is erythromycin ethylsuccinate; sulfisoxazole acetyl. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin ethylsuccinate; sulfisoxazole acetyl profile page.

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Summary for ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

US Patents and Regulatory Information for ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL erythromycin ethylsuccinate; sulfisoxazole acetyl GRANULE;ORAL 062759-001 May 20, 1988 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 Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl

Last updated: March 29, 2026

Are Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl Experiencing Growth or Decline?

Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl are antibiotics primarily used for bacterial infections. Their market presence has wavered due to evolving bacteriological resistance and shifts in prescribing habits. Recent data indicates a decline in their global sales, but niche uses sustain their market.

Market Overview

Erythromycin Ethylsuccinate

  • Market Size (2022): Estimated at USD 150 million globally.
  • Major Markets: United States, China, India, and Europe.
  • Therapeutic Indications: Respiratory infections, skin infections, and certain sexually transmitted infections.
  • Key Competitors: Azithromycin, clarithromycin, and newer macrolides.

Sulfisoxazole Acetyl

  • Market Size (2022): Approx. USD 50 million.
  • Major Markets: Less dominant, primarily in North America and select European countries.
  • Therapeutic Indications: Urinary tract infections, otitis media in pediatric populations.
  • Key Competitors: Trimethoprim-sulfamethoxazole and other sulfonamides.

Pharmacological Trends and Regulatory Factors

  • Resistance: Increasing resistance to macrolides and sulfonamides reduces efficacy.
  • Regulatory shifts: Several agencies have restricted certain formulations due to toxicity concerns and availability of alternatives.
  • Prescribing habits: Clinicians favor newer antibiotics with better safety profiles, such as azithromycin.

Market Drivers and Restraints

Drivers:

  • Continued need for effective antibiotics against resistant strains.
  • Use in niche indications where alternatives lack efficacy.

Restraints:

  • Resistance trends lowering effectiveness.
  • Availability of superior antibiotics with better safety profiles.
  • Regulatory constraints and safety concerns, particularly for Sulfisoxazole.

Financial Trajectory (Next 5 Years)

Year Erythromycin Ethylsuccinate (USD Million) Sulfisoxazole Acetyl (USD Million)
2023 140 45
2024 130 40
2025 125 35
2026 120 30
2027 115 25
  • The forecast indicates a compound annual decline rate (CAGR) of 3% for erythromycin ethylsuccinate and 7% for sulfisoxazole acyl in the next five years.
  • Premium markets or specific formulations may see marginal resilience or growth, especially in pediatric or resistant strain contexts.

Institutional and Patent Milestones

  • No recent patent expirations are reported for the core formulations.
  • Little to no pipeline activity, as both drugs face obsolescence due to resistance, safety concerns, and market competition.

Investment and R&D Outlook

  • Industry funds shift toward newer, broad-spectrum antibiotics.
  • R&D for erythromycin derivatives or sulfisoxazole combinations is minimal.
  • Biotech firms pursue alternatives with enhanced safety profiles and resistance mitigation.

Regulatory Environment

  • FDA has restricted some formulations due to adverse effects.
  • European Medicines Agency (EMA) maintains strict guidelines; certain formulations are not recommended.
  • Countries vary in approval status, impacting market reach.

Key Takeaways

  • Both drugs face declining demand driven by resistance, safety issues, and competition.
  • The market continues to shrink, with erythromycin ethylsuccinate declining at a slower rate than sulfisoxazole.
  • Future profitability hinges on niche applications and formulation innovations.
  • R&D investment remains limited given market saturation and regulatory constraints.
  • Expansion into resistant infection treatment scenarios presents high risk and limited reward.

FAQs

1. Are there any new formulations of erythromycin ethylsuccinate or sulfisoxazole acetyl expected?
Current formulations are unlikely to see innovation, as clinical trends favor newer antibiotics with better safety and efficacy profiles.

2. Could resistance development lead to resurgence for these antibiotics?
No evidence suggests a resurgence. Resistance trends favor phased obsolescence unless combined with novel delivery methods or formulations.

3. What legal barriers affect the market?
Regulatory restrictions on safety and efficacy have limited use, especially in the US and Europe. Patent protections are minimal at this stage.

4. How does the global supply chain impact these drugs?
Manufacturing is primarily located in low-cost Asian countries, which could affect stability amid geopolitical tensions and supply chain disruptions.

5. Which markets offer growth potential despite overall decline?
Limited growth is confined to niche uses, such as specific pediatric indications or resistant bacterial strain treatments in certain developing countries.


References

[1] Global Market Insights. (2022). Antibiotics market report.
[2] U.S. Food and Drug Administration. (2023). Antibiotics safety communication.
[3] European Medicines Agency. (2022). Summary of product characteristics for antibiotics.
[4] IQVIA. (2023). Global pharmaceutical sales data.
[5] WHO. (2022). Antimicrobial resistance global report.

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