ERYTHROMYCIN - Generic Drug Details

What are the generic drug sources for erythromycin and what is the scope of patent protection?

Erythromycin is the generic ingredient in fifty-two branded drugs marketed by Dr Reddys Labs Sa, Parke Davis, Warner Chilcott Llc, Hospira, Azurity, Barr, Norvium Bioscience, 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, Amneal Pharms Co, Torrent, Solvay, Robins Ah, Alembic, Alkem Labs Ltd, Cadila Pharms Ltd, Teva Pharms Usa Inc, Zydus Lifesciences, Zydus Pharms, Watson Labs, Cosette, Life Labs, Amneal Pharms, Ani Pharms, Endo Operations, Ross Labs, Pharmacia And Upjohn, Arbor Pharms Llc, Naska, Wyeth Ayerst, Aurobindo Pharma Usa, Alra, Abbott, Elkins Sinn, Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Nexus, Teva Parenteral, Bristol, Warner Chilcott, Lederle, Purepac Pharm, Bristol Myers Squibb, and Pfizer, and is included in one hundred and thirty-eight 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-six suppliers are listed for this compound.

Summary for ERYTHROMYCIN

US Patents:	0
Tradenames:	52
Applicants:	70
NDAs:	138
Drug Master File Entries:	103
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	136
Patent Applications:	6,999
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
Takeda	Phase 1
Chang Gung Memorial Hospital	Phase 1/Phase 2
Assiut University	N/A

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
Ross Labs	PEDIAMYCIN	erythromycin ethylsuccinate	SUSPENSION/DROPS;ORAL	062305-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Nexus	ERYTHROMYCIN LACTOBIONATE	erythromycin lactobionate	INJECTABLE;INJECTION	215290-001	Feb 14, 2022	AP	RX	No	No
Syosset	E-SOLVE 2	erythromycin	LOTION;TOPICAL	062467-001	Jul 3, 1985		DISCN	No	No
Arbor Pharms Llc	PEDIAMYCIN	erythromycin ethylsuccinate	SUSPENSION;ORAL	062304-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Cosette	ERYTHROMYCIN ESTOLATE	erythromycin estolate	SUSPENSION;ORAL	062169-002	Oct 17, 1990		DISCN	No	No

ERYTHROMYCIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Erythromycin

Introduction

Erythromycin, a widely used antibiotic, is a crucial component in the global pharmaceutical market. The drug's market dynamics are influenced by a variety of factors, including regulatory environments, technological advancements, and changing healthcare needs. Here, we delve into the current market trends, financial projections, and the key drivers shaping the erythromycin market.

Global Market Size and Growth

The global erythromycin market is substantial and growing steadily. As of 2023, the market was valued at approximately USD 15.3 billion and is projected to reach USD 26.0 billion by 2033, growing at a compound annual growth rate (CAGR) of 5.6% during the forecast period[4].

Market Drivers

Prevalence of Bacterial Infections

The increasing prevalence of bacterial infections worldwide is a primary driver of the erythromycin market. As populations grow and new strains of bacteria emerge, the demand for effective antibiotics like erythromycin becomes more pressing, especially in developing regions where healthcare access is improving[2].

Advancements in Drug Formulations

Advancements in drug formulations and delivery methods are enhancing the efficacy and patient compliance of erythromycin. New extended-release formulations, for example, improve therapeutic outcomes and reduce dosing frequency, contributing to the market's growth[2].

Regulatory Environments

Favorable regulatory environments play a significant role in the expansion of the erythromycin market. Regulatory standards ensure the quality and safety of pharmaceuticals, which supports the sustained use of well-established antibiotics like erythromycin[4].

Regional Market Analysis

North America

North America dominates the global erythromycin market with a significant 35% share. This is attributed to the region's advanced pharmaceutical industry, strong focus on healthcare innovation, and high prevalence of bacterial infections. The well-established healthcare infrastructure and stringent regulatory standards in North America also contribute to its leading position[4].

Europe

Europe holds approximately 25% of the global erythromycin market. The region's strong pharmaceutical manufacturing base and high healthcare standards drive consistent demand for erythromycin. Europe's rigorous health regulatory environment further supports the sustained use of this antibiotic[4].

Asia Pacific

The Asia Pacific region accounts for about 30% of the market, driven by rapid healthcare sector growth, especially in countries like China and India. Increasing population, expanding healthcare infrastructure, and rising medical needs significantly contribute to the demand for antibiotics in this region[4].

Price Trends and Market Dynamics

Price Fluctuations

Erythromycin prices have experienced fluctuations due to various market dynamics. In the first half of 2023, prices in the US and European regions followed an inclining trajectory due to growth in sales of pharmaceuticals and increasing energy production costs exacerbated by the Russia-Ukraine crisis. However, in the second quarter of 2024, prices in North America remained consolidated amidst discussions on high drug and healthcare costs[1].

Impact of Regulatory Changes

The Inflation Reduction Act and other regulatory changes have introduced complexity to the erythromycin market. Pharmaceutical companies have planned to raise prices on over 500 drugs, including erythromycin, in response to these changes. Legal battles over the constitutionality of these price controls are ongoing, adding strain to the market[1].

Generic Competition

The erythromycin market faces significant pressure from generic competition, which has led to intense price competition. While this benefits consumers by making the antibiotic more affordable, it reduces profit margins for manufacturers and can discourage investment in research and development for new erythromycin formulations[4].

Financial Impact and Hospital Costs

Hospital Costs and Length of Stay

The use of intravenous erythromycin in hospitals has been associated with significant increases in hospital length of stay and total hospital costs. A retrospective cohort study found that patients treated with intravenous erythromycin had an increased length of stay by 2.14 days and an increased cost of hospitalization by $6,061 compared to those who did not receive erythromycin[5].

Technological Advancements

Biotechnology and Drug Delivery Systems

Advances in biotechnology and drug delivery systems are crucial for the evolution of the erythromycin market. Companies are investing in cutting-edge technologies to streamline drug development, improve manufacturing efficiency, and enhance therapeutic outcomes. These innovations are paving the way for more efficient production processes and better antibiotic therapies[2].

Mergers and Acquisitions

The erythromycin market is witnessing increased activity in terms of mergers and acquisitions. Pharmaceutical companies are forging strategic partnerships to enhance their research and development capabilities, aiming to develop more effective antibiotics and address the growing challenge of antibiotic resistance[2].

Key Takeaways

• Market Growth: The global erythromycin market is expected to grow from USD 15.3 billion in 2023 to USD 26.0 billion by 2033, at a CAGR of 5.6%.
• Regional Dominance: North America leads the market with a 35% share, followed by Europe and the Asia Pacific region.
• Price Trends: Prices are expected to rise due to global surges in medication costs and increased production costs, despite fluctuations influenced by regulatory changes.
• Generic Competition: The market faces pressure from generic competition, affecting profit margins and investment in R&D.
• Technological Advancements: Advances in biotechnology and drug delivery systems are driving market growth and improving therapeutic outcomes.
• Financial Impact: Intravenous erythromycin use is associated with increased hospital costs and length of stay.

FAQs

What is the projected growth rate of the erythromycin market?

The erythromycin market is expected to grow at a CAGR of approximately 5.6% from 2024 to 2033[4].

What are the main drivers of the erythromycin market?

The main drivers include the prevalence of bacterial infections, advancements in drug formulations, and favorable regulatory environments[2][4].

How does generic competition affect the erythromycin market?

Generic competition leads to intense price competition, reducing profit margins for manufacturers and potentially discouraging investment in R&D[4].

What is the impact of intravenous erythromycin on hospital costs?

Intravenous erythromycin use is associated with significant increases in hospital length of stay and total hospital costs, with an increased cost of hospitalization by $6,061[5].

Which region dominates the global erythromycin market?

North America dominates the global erythromycin market with a significant 35% share[4].

What role do technological advancements play in the erythromycin market?

Technological advancements in biotechnology and drug delivery systems are crucial for improving production efficiency, therapeutic outcomes, and addressing antibiotic resistance[2].