Erythromycin ethylsuccinate - Generic Drug Details

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

Erythromycin ethylsuccinate is the generic ingredient in twelve branded drugs marketed by Azurity, Amneal Pharms, Ani Pharms, Cadila Pharms Ltd, Endo Operations, Ross Labs, Pharmacia And Upjohn, Arbor Pharms Llc, Alpharma Us Pharms, Dista, Naska, Parke Davis, Pharmafair, Wyeth Ayerst, Aurobindo Pharma Usa, Barr, and Alra, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for erythromycin ethylsuccinate. Eight suppliers are listed for this compound.

Summary for erythromycin ethylsuccinate

US Patents:	0
Tradenames:	12
Applicants:	17
NDAs:	25
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	1
Patent Applications:	8,715
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
Metabolic Solutions Inc.	Phase 2
University of Florida	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
Ani Pharms	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	GRANULE;ORAL	062055-002	Nov 2, 2018	AB	RX	No	No
Naska	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	SUSPENSION;ORAL	062674-001	Mar 10, 1987		DISCN	No	No
Azurity	ERYTHROMYCIN ETHYLSUCCINATE	erythromycin ethylsuccinate	TABLET;ORAL	061904-001	Approved Prior to Jan 1, 1982	BX	RX	No	Yes
Ross Labs	PEDIAMYCIN	erythromycin ethylsuccinate	SUSPENSION/DROPS;ORAL	062305-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Azurity	E.E.S. 400	erythromycin ethylsuccinate	TABLET;ORAL	061905-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Arbor Pharms Llc	PEDIAMYCIN	erythromycin ethylsuccinate	SUSPENSION;ORAL	062304-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ross Labs	PEDIAMYCIN	erythromycin ethylsuccinate	GRANULE;ORAL	062305-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Erythromycin ethylsuccinate Market Analysis and Financial Projection Experimental

Erythromycin Ethylsuccinate Market Dynamics and Financial Trajectory

Market Overview

Erythromycin ethylsuccinate, a derivative of the antibiotic erythromycin, is widely used to treat various bacterial infections, including respiratory tract infections, skin and soft tissue infections, and genitourinary infections. The market for this drug is influenced by several key factors, including increasing prevalence of infectious diseases, regulatory approvals, and advancements in pharmaceutical manufacturing.

Segmentation and Applications

Formulations and Types

The erythromycin market, including erythromycin ethylsuccinate, is segmented by formulation into gel, tablet, topical solution, ointment, and others. Erythromycin ethylsuccinate is specifically used in oral suspensions and is indicated for treating infections such as upper and lower respiratory tract infections, skin and soft tissue infections, and genitourinary infections[1].

Applications

The drug is used in both human medicine and veterinary medicine. In human medicine, it is primarily used as an antibiotic, while in veterinary medicine, it is used for treating infections in livestock and poultry[2].

Market Drivers

Increasing Prevalence of Infectious Diseases

The rising prevalence of bacterial infections, particularly respiratory tract infections, is a significant driver for the erythromycin ethylsuccinate market. According to the Bill & Melinda Gates Foundation, lower respiratory tract infections (LRIs) resulted in 2.74 million deaths and 103.0 million disability-adjusted life-years (DALYs) globally in 2015, highlighting the need for effective antibiotic treatments[1].

Regulatory Approvals and Access to Affordable Medications

Pharmaceutical manufacturers are focused on increasing access to affordable medications, which includes obtaining regulatory approvals for generic versions of erythromycin ethylsuccinate. For instance, ANI Pharmaceuticals, Inc. launched Erythromycin Ethylsuccinate for oral suspension in 2016, which is a therapeutic equivalent for various infections[1].

Technological Advancements and R&D Efforts

Continuous research and development efforts aimed at enhancing antibiotic formulations and production methods are driving the market growth. Technological advancements in drug manufacturing have improved product quality and production efficiency, making erythromycin ethylsuccinate more accessible and effective[2].

Market Restraints

Allergic Reactions and Side Effects

Signs of allergic reactions to erythromycin, such as swelling of the mouth, face, lips, tongue, or throat, and the risk of higher epilepsy and cerebral palsy in newborn babies when used by pregnant women, are significant restraints on the market[1].

Availability of Alternatives

The increasing availability of alternative antibiotics, such as azithromycin, also hinders the growth of the erythromycin ethylsuccinate market. These alternatives often have fewer side effects and are more convenient to use, making them preferred choices for many patients[1].

Regional Dynamics

North America

The North American market is expected to hold a dominant position due to the rising number of regulatory approvals and the increasing prevalence of skin and soft tissue infections. For example, Rising Pharmaceuticals, Inc. launched an FDA-approved generic version of Benzamycin Gel in 2016, which includes erythromycin and benzoyl peroxide[1].

Global Market

The global erythromycin ethylsuccinate market is segmented into regions such as Europe, Asia Pacific, Latin America, Middle East, and Africa. The market in these regions is driven by the growing need for efficient antibiotic therapies and the expansion of the pharmaceutical industry, especially in emerging markets[2].

Competitive Landscape

Key Players

The market is competitive with key players such as ANI Pharmaceuticals, Inc., Akorn, Inc., Aceto Corporation, Genesis Pharmaceuticals, Teligent, Inc., Abbvie, Inc., Abbott Laboratories, Pfizer, Inc., Sanofi-Aventis, and Allergan, Plc. These companies are focused on the development, manufacturing, and marketing of multisource and branded pharmaceuticals, which includes erythromycin ethylsuccinate[1].

Market Strategies

Companies are adopting strategies such as obtaining FDA approvals for new formulations and expanding their product portfolios to stay competitive. For instance, Teligent, Inc. received FDA approval for its Erythromycin Topical Gel USP in 2017[1].

Financial Trajectory

Market Size and Growth

The erythromycin thiocyanate market, which is closely related to erythromycin ethylsuccinate, was valued at USD 26.08 million in 2023 and is expected to reach USD 38.95 million by 2031, growing at a CAGR of 5% from 2024 to 2031. This growth is driven by the increasing demand for antibiotics and the expansion of the pharmaceutical industry[2].

Price Trends

Erythromycin prices have shown regional variations influenced by government policies and market dynamics. In North America, prices remained stable, while in other regions, prices have seen fluctuations due to factors such as inflation, supply chain disruptions, and regulatory changes. The price trend is expected to rise in the next quarter due to the global surge in medication prices and increased production costs[3].

Economic Impact

The use of intravenous erythromycin, which includes erythromycin ethylsuccinate, has significant economic implications. A study found that intravenous erythromycin use was associated with an increased length of hospital stay and higher hospitalization costs, highlighting the need for careful economic evaluation in treatment decisions[5].

Key Takeaways

• The erythromycin ethylsuccinate market is driven by the increasing prevalence of infectious diseases and regulatory approvals.
• Technological advancements and R&D efforts are enhancing product quality and production efficiency.
• Allergic reactions and the availability of alternative antibiotics are significant restraints.
• The North American market is dominant due to regulatory approvals and high prevalence of skin and soft tissue infections.
• The global market is expected to grow at a CAGR of 5% from 2024 to 2031.

FAQs

1. What are the primary applications of erythromycin ethylsuccinate?

Erythromycin ethylsuccinate is primarily used to treat bacterial infections such as upper and lower respiratory tract infections, skin and soft tissue infections, and genitourinary infections.

2. Which regions are expected to dominate the erythromycin ethylsuccinate market?

North America is expected to hold a dominant position in the erythromycin ethylsuccinate market due to the rising number of regulatory approvals and the increasing prevalence of skin and soft tissue infections.

3. What are the major restraints on the erythromycin ethylsuccinate market?

Significant restraints include signs of allergic reactions, the risk of higher epilepsy and cerebral palsy in newborn babies when used by pregnant women, and the availability of alternative antibiotics like azithromycin.

4. How is the financial trajectory of the erythromycin ethylsuccinate market expected to evolve?

The market is expected to grow at a CAGR of 5% from 2024 to 2031, driven by increasing demand for antibiotics and the expansion of the pharmaceutical industry. Prices are expected to rise due to global surges in medication prices and increased production costs.

5. Which companies are key players in the erythromycin ethylsuccinate market?

Key players include ANI Pharmaceuticals, Inc., Akorn, Inc., Aceto Corporation, Genesis Pharmaceuticals, Teligent, Inc., Abbvie, Inc., Abbott Laboratories, Pfizer, Inc., Sanofi-Aventis, and Allergan, Plc.

Cited Sources:

1. Coherent Market Insights: Erythromycin Market - Share, Size and Industry Analysis[1]
2. Market Research Intellect: Erythromycin Thiocyanate Market Size and Projections[2]
3. Procurement Resource: Erythromycin Price Trend, Index, News, Chart, Database[3]
4. Biospace: Erythromycin Ethylsuccinate Market Size & Share, Regional Demand, Revenue, Key Manufacturers, and 2030[4]
5. PubMed: Clinical and financial impact of intravenous erythromycin therapy in hospital patients[5]