Ethambutol hydrochloride - Generic Drug Details

What are the generic sources for ethambutol hydrochloride and what is the scope of patent protection?

Ethambutol hydrochloride is the generic ingredient in two branded drugs marketed by Barr, Epic Pharma Llc, Lupin, and Kanchan Hlthcare, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for ethambutol hydrochloride. Seven suppliers are listed for this compound.

Summary for ethambutol hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	118
Patent Applications:	6,859
What excipients (inactive ingredients) are in ethambutol hydrochloride?	ethambutol hydrochloride excipients list
DailyMed Link:	ethambutol hydrochloride at DailyMed

Recent Clinical Trials for ethambutol hydrochloride

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

Sponsor	Phase
Critical Path Institute	Phase 2
Instituto de Saude Publica da Universidade do Porto	Phase 2
TASK Applied Science	Phase 2

See all ethambutol hydrochloride clinical trials

Pharmacology for ethambutol hydrochloride

Drug Class

Antimycobacterial

Medical Subject Heading (MeSH) Categories for ethambutol hydrochloride

Antitubercular Agents

Anatomical Therapeutic Chemical (ATC) Classes for ethambutol hydrochloride

J04AK	Other drugs for treatment of tuberculosis
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ethambutol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	ETHAMBUTOL HYDROCHLORIDE	ethambutol hydrochloride	TABLET;ORAL	078939-001	Jun 17, 2009	AB	RX	No	No
Lupin	ETHAMBUTOL HYDROCHLORIDE	ethambutol hydrochloride	TABLET;ORAL	078939-002	Jun 17, 2009	AB	RX	No	No
Barr	ETHAMBUTOL HYDROCHLORIDE	ethambutol hydrochloride	TABLET;ORAL	076057-001	Nov 26, 2001		DISCN	No	No

Ethambutol hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethambutol Hydrochloride

Introduction to Ethambutol Hydrochloride

Ethambutol hydrochloride is a crucial bacteriostatic drug used primarily in the management and treatment of tuberculosis (TB). Its mechanism involves inhibiting cell wall synthesis in mycobacteria, making it an essential component of TB treatment regimens[5].

Global Market Size and Growth

The global ethambutol hydrochloride market is projected to experience significant growth over the coming years. By 2029, the market is expected to reach a substantial value, driven by increasing demand from various end-use industries, particularly the pharmaceutical sector. The market growth is anticipated to be fueled by the expanding demands for ethambutol hydrochloride in capsule and tablet forms[1].

Regional Market Dynamics

Asia-Pacific Region

The Asia-Pacific region, particularly China, is expected to show high growth potential for ethambutol hydrochloride. China, being the second-largest economy, is forecast to drive the market with a notable CAGR over the 2023-2029 period. This growth is attributed to the increasing incidence of TB and the need for effective treatments in this region[1].

North America and Europe

In North America and Europe, the market for ethambutol hydrochloride is also expected to grow, albeit at a slower pace compared to the Asia-Pacific region. The U.S. market, for instance, will exhibit a CAGR during the same period, driven by consistent demand for TB treatments[1].

Application Segments

Capsule and Tablet Forms

The market is segmented primarily into capsule and tablet forms. Both segments are expected to contribute significantly to the overall market growth. The purity of ethambutol hydrochloride, particularly the segments with purity ≥ 99% and ≥ 99.5%, are projected to record substantial CAGRs, indicating a high demand for high-purity formulations[1].

Pharmacokinetics and Bioavailability

Understanding the pharmacokinetics of ethambutol hydrochloride is crucial for its effective use. The drug achieves peak serum concentrations within 2 to 4 hours post-administration and has an oral bioavailability of approximately 80%. Its bioavailability can be affected by factors such as age, especially in children, and the presence of other medications like lopinavir/ritonavir, which can reduce bioavailability by 32%[2][5].

Pricing and Revenue Impact

Authorized Generics

The entry of authorized generics (AGs) into the market can significantly impact the pricing and revenue of ethambutol hydrochloride. AGs are known to lower retail and wholesale prices of generic drugs, with retail prices falling to 70% of the brand price during the 180-day exclusivity period. This competition reduces the revenues of first-filer generic companies by 40-52% during this period and continues to affect their revenues even after the exclusivity period ends[3].

Financial Trajectory

Market Size and Forecast

The global ethambutol hydrochloride market size is expected to grow substantially from 2023 to 2029. The market size in China, for example, is forecast to reach a significant value by 2029, while the U.S. market will also exhibit considerable growth during this period[1].

Revenue and Gross Margin

The revenue and gross margin of ethambutol hydrochloride are influenced by several factors, including the purity of the drug, the form of administration (capsule or tablet), and regional demand. The market is expected to see an increase in revenue due to the growing demand for high-purity formulations and the expanding use in various regions[1].

Key Regions and Sales Breakdown

North America, Europe, and Asia-Pacific

The sales breakdown by region indicates that North America, Europe, and the Asia-Pacific region are key markets for ethambutol hydrochloride. Each region has its own sales dynamics, with the Asia-Pacific region showing the highest growth potential due to the large population and increasing healthcare needs[1].

Challenges and Opportunities

Pharmacokinetic Variability

Pharmacokinetic studies, especially in children and HIV co-infected patients, highlight the need for tailored dosing strategies. Variability in bioavailability and clearance rates among different patient groups presents both challenges and opportunities for pharmaceutical companies to develop more targeted and effective formulations[2].

Competitive Landscape

The competitive landscape is influenced by the presence of authorized generics, which can significantly lower prices and affect the revenues of generic manufacturers. However, this competition also drives innovation and efficiency in the market, potentially leading to better products and services for consumers[3].

Conclusion

The market for ethambutol hydrochloride is poised for significant growth driven by increasing demand, particularly in the Asia-Pacific region. Understanding the pharmacokinetics, bioavailability, and the impact of authorized generics is crucial for navigating this market. As the global healthcare landscape continues to evolve, the financial trajectory of ethambutol hydrochloride is expected to be influenced by these factors.

Key Takeaways

• Growing Market Size: The global ethambutol hydrochloride market is expected to grow substantially by 2029.
• Regional Dynamics: Asia-Pacific, particularly China, will drive market growth.
• Application Segments: Capsule and tablet forms will contribute significantly to market growth.
• Pharmacokinetics: Bioavailability and clearance rates vary among patient groups.
• Authorized Generics: AGs lower prices and affect generic manufacturers' revenues.
• Financial Trajectory: Revenue and gross margin will increase due to growing demand and regional expansion.

FAQs

Q: What is the primary use of ethambutol hydrochloride? A: Ethambutol hydrochloride is primarily used in the management and treatment of tuberculosis (TB)[5].

Q: How does the presence of authorized generics affect the market? A: Authorized generics lower retail and wholesale prices, reducing the revenues of first-filer generic companies by 40-52% during the 180-day exclusivity period[3].

Q: What are the key regions driving the growth of the ethambutol hydrochloride market? A: The Asia-Pacific region, particularly China, and North America are key regions driving market growth[1].

Q: How does the pharmacokinetics of ethambutol hydrochloride vary among different patient groups? A: Pharmacokinetics vary, especially in children and HIV co-infected patients, with factors such as age and co-administered medications affecting bioavailability and clearance rates[2].

Q: What is the expected market size of ethambutol hydrochloride by 2029? A: The global market size is expected to reach a significant value by 2029, driven by growing demand and regional expansion[1].

Sources

1. QYResearch: Ethambutol HCL - Global Market Insights and Sales Trends 2024
2. Oxford Academic: Population pharmacokinetics of ethambutol in African children
3. Federal Trade Commission: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact
4. Market Research Intellect: Ethambutol Hydrochloride Tablets Market Size, Scope And Forecast
5. NCBI Bookshelf: Ethambutol - StatPearls