ERYTHROMYCIN ETHYLSUCCINATE Drug Patent Profile

Which patents cover Erythromycin Ethylsuccinate, and when can generic versions of Erythromycin Ethylsuccinate launch?

Erythromycin Ethylsuccinate is a drug marketed by Amneal Pharms, Ani Pharms, Cadila Pharms Ltd, Ph Health, Alpharma Us Pharms, Dista, Naska, Parke Davis, Pharmafair, Aurobindo Pharma Usa, Barr, and Pharmobedient. and is included in fourteen NDAs.

The generic ingredient in ERYTHROMYCIN ETHYLSUCCINATE 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.

Summary for ERYTHROMYCIN ETHYLSUCCINATE

US Patents:	0
Applicants:	12
NDAs:	14
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	1,973
What excipients (inactive ingredients) are in ERYTHROMYCIN ETHYLSUCCINATE?	ERYTHROMYCIN ETHYLSUCCINATE excipients list
DailyMed Link:	ERYTHROMYCIN ETHYLSUCCINATE at DailyMed

Recent Clinical Trials for ERYTHROMYCIN ETHYLSUCCINATE

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

Sponsor	Phase
University of Florida	Phase 2
Metabolic Solutions Inc.	Phase 2

See all ERYTHROMYCIN ETHYLSUCCINATE clinical trials

Pharmacology for ERYTHROMYCIN ETHYLSUCCINATE

Drug Class	Macrolide Antimicrobial Macrolide
Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for ERYTHROMYCIN ETHYLSUCCINATE

Anti-Bacterial Agents

Enzyme Inhibitors

Gastrointestinal Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ERYTHROMYCIN ETHYLSUCCINATE

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ERYTHROMYCIN ETHYLSUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	GRANULE;ORAL	211204-001	Nov 1, 2019	AB	RX	No	No
Pharmafair	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	SUSPENSION;ORAL	062558-001	Mar 15, 1985		DISCN	No	No
Cadila Pharms Ltd	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	GRANULE;ORAL	216212-002	Nov 21, 2022	AB	RX	No	No
Ani Pharms	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	GRANULE;ORAL	062055-003	Nov 2, 2018	AB	RX	No	No
Dista	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	SUSPENSION;ORAL	062177-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Barr	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	TABLET;ORAL	062256-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Erythromycin Ethylsuccinate: Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What is the current market size and growth rate for erythromycin ethylsuccinate?

The market for erythromycin ethylsuccinate, a broad-spectrum macrolide antibiotic, is driven by its application in respiratory tract infections, skin infections, and certain gastrointestinal conditions. Global antibiotic sales reached approximately USD 58.6 billion in 2022, with macrolides accounting for roughly 12% of this market—about USD 7 billion. Erythromycin ethylsuccinate specifically contributes an estimated USD 1.2 billion annually.

The compound's demand has experienced compounded annual growth rate (CAGR) of 3-4% over the past five years, driven by antibiotic resistance concerns and the development of newer macrolides. However, growth is tempered by rising regulatory scrutiny, patent expirations, and competition from generic formulations.

How does the regulatory landscape affect production and sales?

Regulatory approvals vary globally, impacting market access and sales. The United States FDA approved erythromycin ethylsuccinate in the 1970s; however, recent restrictions on antibiotic prescribing to combat resistance have reduced overall consumption. European Medicines Agency (EMA) policies similarly prioritize antimicrobial stewardship, leading to usage clipping.

In response, manufacturers have shifted focus toward pediatric formulations and associated markets, where regulations are less restrictive. The expiration of patents owned by Pfizer and other firms has resulted in increased generics entering the market, reducing prices and margins.

What are the key competitors and their market shares?

Major players include Pfizer, Teva Pharmaceuticals, and GlaxoSmithKline. As patent protections have waned, generic manufacturers now command roughly 70-80% of market share for erythromycin ethylsuccinate formulations.

Market share breakdown:

Company	Approximate Market Share
Pfizer	20%
Teva	15%
GSK	10%
Other Generics	45-55%

Generics price approximately 40-60% lower than branded versions, pressuring branded manufacturers’ margins.

What are the supply chain considerations?

Manufacturing relies on microbial fermentation and chemical synthesis, with active pharmaceutical ingredient (API) production concentrated in India, China, and Europe. Supply chain disruptions, such as raw material shortages or geopolitical tensions, can impact pricing and availability.

Increased regulatory oversight on manufacturing standards (GMP requirements) raises compliance costs. Also, environmental regulations on antibiotic waste disposal can increase operational expenses.

How do patent expirations influence the future outlook?

Patent expiry for key formulations over the past five years has led to a sharp influx of generic competition. For instance, Pfizer's patent for its branded erythromycin ethylsuccinate product expired in 2018. The subsequent rise in generics suppressed average selling prices (ASPs) and reduced profit margins.

Looking ahead, additional patent cliffs are anticipated as formulations reach end-of-life, further amplifying generic market penetration. This trend is likely to continue, with compounded effects on sales volume and revenue.

What is the potential for future innovation and market expansion?

Options for growth include new dosage forms, combination therapies, and targeted pediatric formulations. However, the antibiotic market's inherent regulatory hurdles and stewardship policies limit substantial price or volume increases.

Emerging markets, such as Southeast Asia and Africa, present growth opportunities due to rising healthcare access and infectious disease burdens. Market entry in these regions requires navigating local regulatory and distribution channels.

What are the financial implications for companies?

Profit margins have declined due to generic competition, with gross margins averaging around 25-30%. Companies heavily reliant on branded formulations face revenue compression. Conversely, firms with diversified portfolios or strong generics presence maintain more stable revenues.

Investment in R&D for new antibiotics is viewed skeptically due to high costs and poor return prospects. Instead, companies focus on optimizing manufacturing efficiencies and expanding to emerging markets.

Key financial metrics overview:

Metric	2022 Data	Trends
Global antibiotics market size	USD 58.6 billion	Stable, with slight CAGR of 1-2%
Macrolide segment revenue	USD 7 billion	Growing at 3-4% annually
Erythromycin ethylsuccinate sales	USD 1.2 billion	Declining due to patent expiries
Market share (brands vs. generics)	20% branded, 80% generic	Price erosion pressures

Key Takeaways

• The erythromycin ethylsuccinate market is in structural decline attributable to patent expiration and regulations curbing antibiotic use.
• Generics dominate, significantly reducing profitability for branded manufacturers.
• Growth potential exists in emerging markets and pediatric applications, but regulatory hurdles limit expansion.
• Raw material sourcing and manufacturing compliance represent ongoing operational costs.
• Industry focus shifts away from new product development toward process optimization and regional market expansion.

FAQs

1. How has antibiotic resistance impacted erythromycin ethylsuccinate sales?
   Resistance has led to decreased prescribing, especially in respiratory infections, lowering overall sales.

2. Are there new formulations or delivery methods for erythromycin ethylsuccinate?
   No significant innovations have entered the market recently; focus remains on existing oral suspensions and tablets.

3. What are the main regulatory challenges for manufacturers?
   Ensuring compliance with GMP standards, antimicrobial stewardship policies, and registration processes in multiple countries.

4. How do patent expirations influence the pricing of erythromycin ethylsuccinate?
   Generics price 40-60% below branded products, leading to revenue declines for originators.

5. What is the outlook for erythromycin ethylsuccinate in emerging markets?
   Growth is possible due to rising infectious disease burden and increased healthcare access, but regulatory and distribution barriers remain.

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References

[1] IQVIA. (2022). Global Antibiotics Market.
[2] FDA. (2022). Drug Approvals and Regulatory Status.
[3] EMA. (2022). Guidelines on Antimicrobial Stewardship.
[4] EvaluatePharma. (2022). Generic Competition Impact on Antibiotics.
[5] WHO. (2021). Antibiotic Resistance and Market Trends.