Erythromycin stearate - Generic Drug Details

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

Erythromycin stearate is the generic ingredient in eight branded drugs marketed by Bristol, Parke Davis, Warner Chilcott, Azurity, Ani Pharms, Lederle, Norvium Bioscience, Purepac Pharm, Watson Labs, Bristol Myers Squibb, Pfizer, and Wyeth Ayerst, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for erythromycin stearate.

Summary for erythromycin stearate

US Patents:	0
Tradenames:	8
Applicants:	12
NDAs:	15
Drug Master File Entries:	18
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	1
Patent Applications:	6,996
Drug Prices:	Drug price trends for erythromycin stearate
What excipients (inactive ingredients) are in erythromycin stearate?	erythromycin stearate excipients list
DailyMed Link:	erythromycin stearate at DailyMed

See drug prices for erythromycin stearate

Recent Clinical Trials for erythromycin stearate

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

Sponsor	Phase
Chr Hansen	N/A
Ryerson University	N/A
Chr Hansen A/S	N/A

See all erythromycin stearate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for erythromycin stearate

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 stearate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	ERYTHROMYCIN STEARATE	erythromycin stearate	TABLET;ORAL	061505-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	ERYTHROMYCIN STEARATE	erythromycin stearate	TABLET;ORAL	062089-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Parke Davis	ERYPAR	erythromycin stearate	TABLET;ORAL	062032-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bristol Myers Squibb	ETHRIL 500	erythromycin stearate	TABLET;ORAL	061605-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	ERYTHROMYCIN STEARATE	erythromycin stearate	TABLET;ORAL	062089-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Erythromycin stearate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Erythromycin Stearate

Introduction

Erythromycin stearate, a derivative of the macrolide antibiotic erythromycin, is widely used for treating various bacterial infections. The market dynamics and financial trajectory of this drug are influenced by several factors, including regulatory changes, market demand, production costs, and global health trends.

Market Demand and Growth

The demand for erythromycin stearate is driven by the increasing prevalence of bacterial infections worldwide. As populations grow and new strains of bacteria emerge, the need for effective antibiotics like erythromycin stearate becomes more pressing, particularly in developing regions where access to healthcare is improving[3].

• Global Growth: The erythromycin estolate market, which includes erythromycin stearate, is expected to grow at a compound annual growth rate (CAGR) of approximately 5% over the next five years. This growth is fueled by increasing healthcare needs, rising incidences of bacterial infections, and advancements in drug formulations[3].
• Regional Markets: North America and Europe are significant markets due to their well-established healthcare infrastructure and high demand for antibiotics. The Asia-Pacific region is also emerging as a key market, driven by rapid urbanization and improving healthcare access[3].

Regulatory Environment

Regulatory changes significantly impact the market dynamics of erythromycin stearate.

• Price Controls: In India, the government has reduced costs for essential medicines, including erythromycin, to improve affordability. This has led to price relaxations in the Indian market[1].
• Banned Formulations: The ban on certain fixed-dose combinations (FDCs) of erythromycin in India has affected market sentiments and demand temporarily. However, this move is seen as a positive step towards patient safety and has spurred enthusiasm for new drug formulations[1].

Production Costs and Supply Chain

The production costs and supply chain dynamics play a crucial role in the financial trajectory of erythromycin stearate.

• Raw Material Costs: The cost of production is influenced by the global surge in the pricing of certain medications and the rise in energy costs, particularly due to the Russia-Ukraine crisis. These factors have escalated the production costs of erythromycin stearate[1].
• Supply Chain Issues: In Europe, supply chain issues and shipment availability have been significant concerns. A coalition of six countries has warned against excessive national stockpiling, which could lead to shortages, and urged for coordinated strategies to maintain solidarity[1].

Financial Trajectory

The financial trajectory of erythromycin stearate is marked by fluctuations and steady growth.

• Price Trends: In the US, the price of erythromycin has seen significant increases between 2010 and 2015, rising from 24 cents per 500mg tablet to $8.96. Medicaid spending on erythromycin also increased substantially during this period[2].
• Future Projections: Analysts predict that the price of erythromycin stearate is likely to rise in the next quarter due to high demand from end-user industries and lower rates of production. The global surge in medication prices and increased production costs are expected to drive this upward trend[1].

Quality and Compliance

The quality of erythromycin stearate tablets is a critical factor in maintaining market trust and compliance.

• Quality Assessment: Studies have shown that not all commercially available brands of erythromycin stearate meet the required standards. For instance, a quality assessment study found that only 66.67% of the brands passed the test for the content of the active ingredient, and all brands failed the friability test[5].

Technological Advancements

Technological advancements are transforming the erythromycin stearate market.

• Advanced Formulations: New formulations and delivery methods, such as extended-release formulations, are enhancing the drug’s efficacy and patient compliance. These innovations are driven by investments in biotechnology and drug delivery systems[3].
• Manufacturing Efficiency: Companies are adopting cutting-edge technologies to streamline drug development and improve manufacturing efficiency, which is expected to boost the market growth[3].

Economic Impact

The economic impact of erythromycin stearate is significant, especially in the context of healthcare expenditures.

• Healthcare Costs: In India, the high medical inflation rate of 14% underscores the need for comprehensive healthcare solutions, including capping the cost of essential drugs like erythromycin stearate[1].
• Global Market Size: The global erythromycin thiocyanate market, which is closely related to erythromycin stearate, was valued at USD 26.08 million in 2023 and is expected to reach USD 38.95 million by 2031, growing at a 5% CAGR[4].

Key Takeaways

• Growing Demand: The demand for erythromycin stearate is driven by increasing bacterial infections and advancements in drug formulations.
• Regulatory Impact: Price controls and bans on certain formulations affect market dynamics.
• Production Costs: Global surges in medication prices and energy costs influence production costs.
• Quality Compliance: Ensuring the quality of erythromycin stearate tablets is crucial for market trust.
• Technological Advancements: New formulations and technologies are enhancing efficacy and manufacturing efficiency.
• Economic Impact: The drug has a significant economic impact on healthcare expenditures globally.

FAQs

1. What are the primary drivers of the erythromycin stearate market? The primary drivers include the growing prevalence of bacterial infections, advancements in drug formulations, and increasing healthcare needs, especially in developing regions.

2. How have regulatory changes impacted the erythromycin stearate market? Regulatory changes, such as price controls in India and the ban on certain FDCs, have affected market sentiments and demand. However, these moves are seen as positive steps towards patient safety.

3. What are the current challenges in the supply chain of erythromycin stearate? Supply chain issues, including shipment availability and the risk of excessive national stockpiling, are significant concerns, particularly in Europe.

4. How are technological advancements influencing the erythromycin stearate market? Technological advancements in biotechnology and drug delivery systems are leading to more efficient production processes, better therapeutic options, and enhanced patient compliance.

5. What is the projected growth rate of the erythromycin estolate market, which includes erythromycin stearate? The erythromycin estolate market is expected to grow at a CAGR of approximately 5% over the next five years.

Sources

1. Procurement Resource: Erythromycin Price Trend, Index, News, Chart, Database.
2. Wikipedia: Erythromycin.
3. Market Research Intellect: Pharma and Healthcare Disruptions Erythromycin Estolate Market Trends to Watch.
4. Market Research Intellect: Erythromycin Thiocyanate Market Size and Projections.
5. AJOL: Quality assessment of brands of erythromycin stearate tablets.