Erythromycin - Generic Drug Details

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

Erythromycin is the generic ingredient in fifty-two branded drugs marketed by Dr Reddys Labs Sa, Parke Davis, Warner Chilcott Llc, Hospira, Barr, Pharmobedient, Altana, Mylan, Encube, Fougera Pharms, Padagis Us, Syosset, Bausch And Lomb, Pharmaderm, Pharmafair, Sentiss, Dista, Bausch, Paddock Llc, Taro, Arbor Pharms Inc, Merz Pharms, Micro Labs, Epic Pharma Llc, Alpharma Us Pharms, Lilly, Pai Holdings Pharm, Pharmobedient Cnsltg, Renaissance Pharma, Dow Pharm, Westwood Squibb, Ivax Sub Teva Pharms, Johnson And Johnson, Azurity, Amneal Pharms Co, Torrent, Solvay, Robins Ah, Abon Pharms Llc, Alembic, Alkem Labs Ltd, Cadila Pharms Ltd, Teva Pharms Usa Inc, Zydus Lifesciences, Zydus Pharms, Watson Labs, Cosette, Life Labs, Carnegie, Amneal Pharms, Ani Pharms, Ph Health, Ross Labs, Pharmacia And Upjohn, Arbor Pharms Llc, Naska, Wyeth Ayerst, Aurobindo Pharma Usa, Alra, Abbott, Elkins Sinn, Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Gland, Nexus, Teva Parenteral, Bristol, Warner Chilcott, Lederle, Purepac Pharm, Bristol Myers Squibb, and Pfizer, and is included in one hundred and forty NDAs. Additional information is available in the individual branded drug profile pages.

There are one hundred and three drug master file entries for erythromycin. Thirty-four suppliers are listed for this compound.

Summary for erythromycin

US Patents:	0
Tradenames:	52
Applicants:	73
NDAs:	140
Drug Master File Entries:	103
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	147
Patent Applications:	6,974
Drug Prices:	Drug price trends for erythromycin
Drug Sales Revenues:	Drug sales revenues for erythromycin
What excipients (inactive ingredients) are in erythromycin?	erythromycin excipients list
DailyMed Link:	erythromycin at DailyMed

See drug prices for erythromycin

See drug sales revenues for erythromycin

Recent Clinical Trials for erythromycin

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

Sponsor	Phase
La Trobe University	NA
University of Sydney	NA
The University of Western Australia	NA

See all erythromycin clinical trials

Pharmacology for erythromycin

Drug Class	Macrolide Antimicrobial Macrolide
Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for erythromycin

Anti-Bacterial Agents

Gastrointestinal Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for erythromycin

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sentiss	ERYTHROMYCIN	erythromycin	OINTMENT;OPHTHALMIC	064030-001	Jul 18, 1996	AT	RX	No	No
Lilly	ILOSONE	erythromycin estolate	SUSPENSION;ORAL	050010-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Hospira	ERYTHROCIN	erythromycin lactobionate	INJECTABLE;INJECTION	050182-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmafair	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	SUSPENSION;ORAL	062559-001	Mar 15, 1985		DISCN	No	No
Hospira	ERYTHROCIN	erythromycin lactobionate	INJECTABLE;INJECTION	050182-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Ani Pharms	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	GRANULE;ORAL	062055-002	Nov 2, 2018	AB	RX	No	No

Market Dynamics and Financial Trajectory for Erythromycin: An In-Depth Analysis

Last updated: July 27, 2025

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Introduction

Erythromycin, a macrolide antibiotic discovered in the 1950s, remains a pivotal drug in infectious disease management. Despite the advent of newer antibiotics, erythromycin maintains relevance owing to its efficacy, safety profile, and extensive historical data. This report examines the current market dynamics, competitive landscape, regulatory factors, and forecasted financial trajectory of erythromycin within the global pharmaceutical industry.

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Historical Context and Therapeutic Role

Erythromycin’s significance stemmed from its broad-spectrum antibacterial activity, especially against atypical pathogens such as Mycoplasma, Chlamydia, and Legionella. Its introduction revolutionized outpatient infections management, providing a safe alternative for penicillin-allergic patients (1). Over the decades, erythromycin formulations—originally in oral and injectable forms—have faced competition from newer macrolides like azithromycin and clarithromycin, which offer improved dosing schedules and fewer side effects. Nevertheless, erythromycin persists as a first-line option in certain clinical scenarios and remains widely prescribed in developing countries with limited access to newer agents.

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Current Market Dynamics

Global Market Size and Growth

The erythromycin market experienced fluctuations over the past decade, largely influenced by antibiotic stewardship initiatives, generic drug competition, and evolving clinical guidelines. According to recent industry reports, the global erythromycin market was valued at approximately $350 million in 2022, with a compound annual growth rate (CAGR) estimated at 2-3% through 2028 (2). The steady growth primarily reflects demand in emerging markets where antibiotics are integral to primary healthcare infrastructure.

Regional Market Trends

• North America & Europe: Market saturation and mature pharmaceutical landscapes have led to aggressive generic competition. Erythromycin prescriptions are declining proportionally due to the preference for newer antibiotics with better tolerability and dosing convenience (3). Regulatory bodies emphasize antimicrobial stewardship, further limiting erythromycin’s regional growth prospects.

• Asia-Pacific & Latin America: These regions represent the fastest-growing segments, driven by expanding healthcare access, increased infectious disease burden, and affordability of generic formulations. Countries like India, China, and Brazil are major markets, with local manufacturers producing erythromycin at lower costs to meet rising demand (4).

Competitive Landscape

The market is predominantly populated by generic manufacturers who benefit from patent expirations dating back decades—most notably the original patent expired in the early 2000s. Big pharmaceutical companies, including Teva, Mylan, and Sun Pharmaceutical, hold significant share via globally recognized manufacturing capabilities. The market entry barriers are relatively low, fostering a highly competitive environment that exerts downward pressure on prices.

Drug Formulations and Patent Landscape

Erythromycin remains available in various formulations: tablets, suspensions, topical ointments, and injectables. While no further patent protections exist, formulations with modified release or combination therapies are areas of ongoing innovation. Biotech firms are exploring erythromycin derivatives to improve pharmacokinetic profiles, though none have reached commercialization significant enough to alter current dynamics substantially.

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Regulatory and Prescriptive Trends

Regulatory agencies, including the FDA and EMA, advocate judicious antibiotic use to combat antimicrobial resistance (AMR). This stance influences prescribing practices, often favoring newer agents with more specific activity spectra or better safety profiles. Consequently, erythromycin’s utilization is gradually declining in hospitals and outpatient settings within developed countries, although its role in community settings persists.

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Financial Trajectory and Future Outlook

Revenue Projections

The erythromycin market is projected to grow modestly at a CAGR of 2-3% over the next five years. The main drivers include:

• Continued demand in emerging markets
• Stable generic supply chains
• Expansion of erythromycin use in veterinary medicine (which accounts for an estimated 5-10% of total erythromycin sales, depending on regional regulations) (5)

However, growth is constrained by:

• Declining prescriptions in the United States and Europe due to stewardship programs
• Rising concerns over antibiotic resistance, which may restrict indications (6)

Pricing Trends

Market prices are under persistent pressure due to generic competition. The average wholesale price (AWP) for erythromycin tablets has declined by approximately 30% over the past decade, with further declines anticipated. Margins remain narrow, emphasizing reliance on high-volume sales strategies especially in generics manufacturing.

Emerging Opportunities

• Development of Ester Derivatives and New Formulations: These aim to improve bioavailability, reduce adverse effects, and extend patent life.
• Use in Combination Therapies: Combining erythromycin with other antimicrobial agents to combat resistant strains could rejuvenate market interest.
• Veterinary Applications: The persistent use in livestock and pet medicine presents an alternative revenue stream, especially in regions with favorable regulatory environments.

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Challenges Impacting Financial Trajectory

• Antimicrobial Resistance: Erythromycin resistance rates are rising globally, especially among Streptococcus pneumoniae and Staphylococcus aureus, limiting clinical efficacy and thus market size (7).
• Early Adoption of Targeted Therapy: Precision medicine approaches favor narrow-spectrum drugs, reducing erythromycin’s utility.
• Regulatory Pushback: Stricter guidelines on antibiotic use decrease prescription volumes.

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Strategic Considerations for Stakeholders

• Manufacturers: Focus on formulations with improved safety profiles or novel delivery mechanisms.
• Investors: Assess regional market drivers, especially in countries with rising healthcare access and broad antibiotic use.
• Healthcare Policy Makers: Implement stewardship programs that balance infection control with appropriate erythromycin utilization to optimize financial returns without fostering resistance.

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Conclusion

Erythromycin’s market landscape is characterized by stable but moderate growth driven by emerging markets, with declining prominence in developed countries. Generic manufacturing and regional healthcare trends dictate its financial trajectory, with narrow margins and resistance concerns shaping future potential. Stakeholders should prioritize innovation within formulation sciences and strategic market expansion to sustain profitability in this mature but enduring antibiotic segment.

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Key Takeaways

• The erythromycin market is projected to grow at a modest CAGR of 2-3% through 2028, primarily fueled by demand in emerging economies.
• Brand and generic competition significantly suppress prices, constraining profit margins.
• Rising antimicrobial resistance and stricter prescribing guidelines are reducing erythromycin’s usage in developed markets.
• Opportunities exist in new formulations, combination therapies, and veterinary applications, which can help prolong commercial viability.
• Stakeholders must navigate regulatory environments carefully, balancing antimicrobial stewardship with market sustainability.

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FAQs

1. What factors are driving erythromycin's renewed relevance in certain markets?
Emerging economies with increasing healthcare access and less stringent antibiotic regulations sustain consistent demand, especially where affordable generic options meet local needs.

2. How does antimicrobial resistance affect erythromycin's market prospects?
Rising resistance diminishes erythromycin’s clinical effectiveness, leading to reduced prescriptions and limiting market growth, especially in respiratory and skin infections.

3. Are there any recent innovations in erythromycin formulations?
While no groundbreaking formulations have reached widespread adoption, research into ester derivatives and sustained-release formulations aims to boost efficacy and minimize side effects.

4. How is the patent landscape influencing erythromycin's market?
The original patents expired decades ago, resulting in intense generic competition that sustains low pricing but limits high-margin opportunities.

5. What strategic moves can pharmaceutical companies consider to maximize erythromycin’s value?
Innovation in formulation, exploring combination therapies, and expanding veterinary applications can extend erythromycin’s lifecycle amid market challenges.

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References

1. [1] Goodman & Gilman's The Pharmacological Basis of Therapeutics, 13th Edition.
2. [2] Industry Reports: Global Antibiotics Market Analysis, 2023.
3. [3] CDC Antibiotic Prescribing Data, 2022.
4. [4] MarketsandMarkets: Asia-Pacific Antibiotics Market, 2023.
5. [5] Veterinary Antimicrobials Market Report, 2022.
6. [6] World Health Organization: Antimicrobial Resistance Surveillance, 2021.
7. [7] Clinical Infectious Diseases Journal: Resistance Trends in Macrolide-Resistant Bacteria, 2022.