Triclabendazole - Generic Drug Details

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

Triclabendazole is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for triclabendazole. One supplier is listed for this compound.

Summary for triclabendazole

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	2
Patent Applications:	2,637
What excipients (inactive ingredients) are in triclabendazole?	triclabendazole excipients list
DailyMed Link:	triclabendazole at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for triclabendazole

Constraining patent/regulatory exclusivity:

INDICATED FOR THE TREATMENT OF FASCIOLIASIS IN PATIENTS 6 YEARS OF AGE AND OLDER

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for triclabendazole

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4
University of Colorado, Denver

See all triclabendazole clinical trials

Pharmacology for triclabendazole

Drug Class	Anthelmintic
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2A6 Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for triclabendazole

P02BX	Other antitrematodal agents
P02B	ANTITREMATODALS
P02	ANTHELMINTICS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for triclabendazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EGATEN	triclabendazole	TABLET;ORAL	208711-001	Feb 13, 2019		RX	Yes	Yes
Novartis	EGATEN	triclabendazole	TABLET;ORAL	208711-001	Feb 13, 2019		RX	Yes	Yes

Triclabendazole Market Analysis and Financial Projection Experimental

Triclabendazole Market Dynamics and Financial Trajectory

Market Overview

Triclabendazole, a potent anthelmintic flukicide belonging to the benzimidazole chemical family, is widely used in the treatment of liver fluke infections in livestock. Here’s a comprehensive look at the market dynamics and financial trajectory of triclabendazole.

Global Market Size and Growth

The global triclabendazole market generated revenue of approximately USD 490 million in 2021 and is projected to grow to USD 632.9 million by 2030, with a compound annual growth rate (CAGR) of 4.1% during the forecast period from 2022 to 2030[1][3][5].

Growth Factors

Several factors are driving the growth of the triclabendazole market:

• Increasing Demand for Animal Protein: The rising demand for high-quality animal protein, particularly in the dairy and meat sectors, is boosting the need for effective livestock health management, including the use of triclabendazole[3].
• Preventive Healthcare: Increased spending on preventive healthcare for livestock, especially in regions with large livestock populations like North America and Europe, is a significant driver[1][3].
• Veterinary Infrastructure: The expansion of veterinary hospitals, clinics, and pharmacies is making triclabendazole more accessible to animal owners, further driving market growth[3].

Regional Analysis

The global triclabendazole market is segmented into several regions, each with its own market dynamics:

North America

North America dominated the global triclabendazole market in 2020, accounting for 30.9% of the market share. This dominance is attributed to a large livestock population, increased spending on preventive healthcare, and a rise in the number of veterinary clinics in the U.S.[1].

Europe

Europe also holds a significant share of the global market due to the presence of several key players in animal health and a large livestock population. The region is expected to remain attractive during the forecast period[1].

Asia Pacific

The Asia Pacific region is another key market for triclabendazole, driven by countries like China, Japan, and India, where there is a growing demand for animal protein and an increasing focus on livestock health[1][3].

Latin America and Middle East & Africa

These regions also contribute to the market growth, although to a lesser extent, due to smaller but growing livestock industries and increasing awareness about animal health[1][3].

Segmentation

The triclabendazole market is segmented based on several criteria:

Dosage Form

Triclabendazole is available in various forms, including tablets, oral suspensions, and occasionally in boluses or other forms. The tablet and oral suspension segments are the most prominent[1][3].

Animal Type

The drug is primarily used for cattle, sheep, and goats, with these segments driving the majority of the market demand[1][3].

Distribution Channel

Veterinary hospitals, clinics, pharmacies, and drug stores are the main distribution channels. Veterinary hospitals dominated the market in 2020, accounting for 26.4% of the market share[3].

Key Players

Several prominent players are active in the global triclabendazole market, including:

• AdvaCare Pharma
• RV Lifesciences Limited
• Grampus Laboratories
• Intas Pharmaceuticals Ltd.[3]

Challenges and Opportunities

Resistance to Triclabendazole

There are reports of resistance to triclabendazole in certain regions, such as the Andes, which could pose a challenge to market growth. However, this also presents an opportunity for research and development of new formulations or combination therapies[2].

Impact of COVID-19

The COVID-19 pandemic has influenced the market through the increased use of telehealth and eHealth services, which have changed the way veterinary care is delivered. However, the launch of vaccines for fasciola species may affect sales of triclabendazole therapeutics[3].

E-commerce and Local Production

The rise of e-commerce is expanding revenue streams for triclabendazole manufacturers. Additionally, increasing local production capacities, especially in the form of tablets and oral suspensions, is helping to meet the growing demand[3].

Financial Projections

The market is expected to continue its growth trajectory, driven by the increasing demand for animal protein and the expanding dairy industry. Here are some key financial projections:

• Market Size: Expected to reach USD 632.9 million by 2030[1][3].
• CAGR: Projected at 4.1% from 2022 to 2030[1][3].

Market Attractiveness Analysis

The attractiveness of the triclabendazole market varies by region, dosage form, animal type, and distribution channel. North America and Europe are expected to remain highly attractive due to their large livestock populations and well-developed veterinary infrastructures[1][3].

Conclusion

The triclabendazole market is poised for steady growth, driven by increasing demand for animal protein, preventive healthcare measures, and the expansion of veterinary infrastructure. While challenges such as resistance to the drug and the impact of COVID-19 exist, opportunities in e-commerce, local production, and research into new formulations are expected to support market growth.

Key Takeaways

• The global triclabendazole market is projected to grow to USD 632.9 million by 2030.
• North America and Europe are the leading regions in the market.
• The market is driven by the demand for animal protein and preventive healthcare.
• Key players include AdvaCare Pharma, RV Lifesciences Limited, and Intas Pharmaceuticals Ltd.
• Challenges include resistance to triclabendazole and the impact of COVID-19.

FAQs

Q: What is the current market size of the global triclabendazole market? A: The global triclabendazole market generated revenue of approximately USD 490 million in 2021[1].

Q: What is the projected CAGR of the triclabendazole market from 2022 to 2030? A: The market is expected to expand at a CAGR of 4.1% during the forecast period from 2022 to 2030[1][3].

Q: Which regions dominate the global triclabendazole market? A: North America and Europe are the dominant regions in the global triclabendazole market[1].

Q: What are the primary dosage forms of triclabendazole? A: Triclabendazole is primarily available in tablet and oral suspension forms[1][3].

Q: What are the main distribution channels for triclabendazole? A: Veterinary hospitals, clinics, pharmacies, and drug stores are the main distribution channels[3].

Cited Sources

1. Nova One Advisor: Triclabendazole Market Size, Share & Trends Report, 2022-2030
2. Science.gov: Triclabendazole combination flukicides: Topics by Science.gov
3. Transparency Market Research: Triclabendazole Market | Global Analysis Report 2031
4. Market Research Intellect: Triclabendazole Sales Market Size, Scope And Forecast Report
5. Cognitive Market Research: Global Triclabendazole Market Report 2024 Edition