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Last Updated: March 26, 2026

Erythromycin ethylsuccinate; sulfisoxazole acetyl - Generic Drug Details


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What are the generic sources for erythromycin ethylsuccinate; sulfisoxazole acetyl and what is the scope of patent protection?

Erythromycin ethylsuccinate; sulfisoxazole acetyl is the generic ingredient in three branded drugs marketed by Barr, Alra, and Ross Labs, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for erythromycin ethylsuccinate; sulfisoxazole acetyl
US Patents:0
Tradenames:3
Applicants:3
NDAs:3
DailyMed Link:erythromycin ethylsuccinate; sulfisoxazole acetyl at DailyMed

US Patents and Regulatory Information for erythromycin ethylsuccinate; 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
Alra ERYZOLE erythromycin ethylsuccinate; sulfisoxazole acetyl GRANULE;ORAL 062758-001 Jun 15, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ross Labs PEDIAZOLE erythromycin ethylsuccinate; sulfisoxazole acetyl GRANULE;ORAL 050529-001 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

Erythromycin ethylsuccinate; sulfisoxazole acetyl Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl?

Erythromycin ethylsuccinate and sulfisoxazole acetyl are antibiotics with established traditional use. Market valuation remains moderate, driven by factors including resistance development, regulatory restrictions, and the prevalence of infectious diseases.

Erythromycin Ethylsuccinate

Market Size and Demand
Global erythromycin market was valued at approximately $440 million in 2021 [1]. Antibiotics like erythromycin ethylsuccinate account for about 15% of total macrolide antibiotic sales, with a focus on respiratory tract infections, skin infections, and prophylaxis during dental procedures.

Key Drivers

  • Antimicrobial Resistance (AMR): Rising resistance to erythromycin reduces efficacy, resulting in decreased prescription volume in developed countries.

  • Regulatory Constraints: Stricter antimicrobial stewardship policies restrict outpatient usage, especially in Europe and North America.

  • Pricing and Patent Status: The drug is off-patent, leading to generic competition with average wholesale prices (AWP) declining to approximately $0.20 per 100 mg dose [2].

Supply Chain and Manufacturing
Producers include generic companies mainly in India, China, and the US, with manufacturing volumes stable but vulnerable to supply chain disruptions due to raw material shortages.

Sulfisoxazole Acetyl

Market Size and Demand
Sulfisoxazole acetyl's market has declined significantly over the past decade. In 2010, the global sulfonamide antibiotics market was valued at around $350 million; sulfisoxazole's share diminished due to resistance and safety concerns [3].

Key Drivers

  • Resistance and Safety: Resistance to sulfonamides has limited clinical utility. Adverse reactions, such as hypersensitivity and Stevens-Johnson syndrome, led to decreased prescriptions.

  • Regulatory Status: In the US, sulfisoxazole is available as a generic but has limited indications, such as urinary tract infections, with use declining steadily.

  • Market Attrition: It faces stiff competition from newer antibiotics like trimethoprim-sulfamethoxazole and other classes, reducing market share.

Future Market Outlook

Aspect erythromycin ethylsuccinate sulfisoxazole acetyl
Market growth Estimated to decline at 2-3% annually, influenced by AMR, with a PT rate reduction expected to continue Declining, with some niche use in specific resistant infections or research; slow reduction expected
Patent status Off-patent Off-patent
Price trend Prices remain low; further decline likely Consistent decline
Competition High from other macrolides like azithromycin High from newer sulfonamides and other classes

What Are the Key Factors Affecting Clinical Use and Regulatory Framework?

  • AMR (Antimicrobial Resistance): Both drugs face resistance issues, reducing efficacy and thereby diminishing demand. Resistant strains decrease clinical utility and restrict use to specific cases.

  • Regulatory Environment: Several countries implement antimicrobial stewardship programs that restrict over-the-counter or broad-spectrum antibiotic use, indirectly reducing demand.

  • Resistance Management: WHO guidelines prioritize minimizing use of older antibiotics such as sulfisoxazole because of resistance and safety concerns.

How Does Market Competition Affect Pricing and R&D?

  • Generic Competition: Both drugs are widely available as generics, resulting in low prices and limited R&D incentives.

  • Limited Innovation: Due to the age of these drugs, few companies invest in reformulations or new indications. Clinical trials on resistant strains are rare, and patent protection is absent.

What Is the Financial Trajectory Outlook?

  • Erythromycin Ethylsuccinate: With declining demand, revenues are expected to decrease modestly, with an annual compound decline rate (CDR) of 2-3%. Nevertheless, volumes remain stable enough to sustain some profitability for generic manufacturers.

  • Sulfisoxazole Acetyl: The market continues to shrink; revenues are projected to decline at a CDR of approximately 5%. Market exit by some producers is possible, further reducing supply and increasing prices.

Conclusion

Both drugs are characterized by market contraction driven by resistance, safety issues, and competition. Erythromycin ethylsuccinate maintains a residual demand primarily in specific indications, but overall market size shrinks annually. Sulfisoxazole acetyl’s market is in decline, with limited prospects for recovery.


Key Takeaways

  • The global erythromycin market faces a steady decline, with generic sales dominant and prices decreasing.
  • Sulfisoxazole acetyl has diminished to niche use due to resistance and safety concerns, with revenues declining faster than erythromycin.
  • Resistance limits future growth; regulatory restrictions and generic competition suppress prices.
  • Innovation in both drugs is unlikely without significant clinical breakthroughs or new indications.
  • Market exit or consolidation could occur as demand continues to contract.

FAQs

1. What determines the future demand for erythromycin ethylsuccinate?
Demand declines mainly due to rising resistance rates and stricter antimicrobial stewardship, although specific niche uses preserve some demand.

2. Are there efforts to develop new formulations or derivatives?
Research is limited; most companies focus on newer macrolides like azithromycin with better pharmacokinetics and safety profiles.

3. How significant is resistance in affecting sulfisoxazole acetyl's market?
Resistance has rendered sulfisoxazole largely obsolete in many regions, significantly diminishing its clinical use and market size.

4. How do pricing trends compare between erythromycin and sulfisoxazole?
Both drugs show declining prices, with erythromycin prices stabilizing at low levels and sulfisoxazole prices decreasing further due to limited demand.

5. What role do regulatory agencies play in shaping their markets?
Regulatory agencies promote antimicrobial stewardship that restricts use, particularly for older antibiotics like sulfisoxazole, influencing market volumes and commercial viability.


References

[1] ReportLinker. (2022). Global antibiotics market size.
[2] IQVIA. (2022). Average Wholesale Prices for antibiotics.
[3] MarketsandMarkets. (2012). Sulfonamide market report.

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