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:	3
What excipients (inactive ingredients) are in triclabendazole?	triclabendazole excipients list
DailyMed Link:	triclabendazole at DailyMed

Recent Clinical Trials for triclabendazole

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

Sponsor	Phase
Oxfendazole Development Group	PHASE2
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE2
Universidad Peruana Cayetano Heredia	PHASE2

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

Market Dynamics and Financial Trajectory for Triclabendazole

Last updated: March 5, 2026

What is Triclabendazole and its approved uses?

Triclabendazole is an anthelmintic agent primarily used to treat fascioliasis and paragonimiasis, parasitic infections caused by liver flukes and lung flukes. It is marketed under brand names such as Egaten (by Novartis). The drug is approved in several countries, including the European Union, Australia, and some developing nations, especially where fascioliasis is endemic.

What is the current market size and key demand drivers?

Estimated Market Size (2023)

Measure	Value
Global anti-parasitic drug market	USD 11 billion (estimated)
Specific market for triclabendazole (est.)	USD 150 million to USD 200 million

The market for triclabendazole is limited compared to broader antiparasitic segments due to its narrow FDA/EMA approval scope and geographic focus.

Key demand drivers

• Endemic disease prevalence: Fascioliasis affects an estimated 2.4 million globally, mainly in Latin America, Africa, and Asia. It drives demand in these regions.
• Regulatory approval extensions: Expanded approval for additional indications or geographic markets increases demand.
• Public health initiatives: WHO recommends triclabendazole for mass drug administration (MDA) in endemic regions.
• Limited competition: Benzimidazoles like albendazole or praziquantel are less effective for fascioliasis, positioning triclabendazole as a preferred agent.

What factors influence its market dynamics?

Regulatory landscape

• Several countries officially approve triclabendazole. However, regulatory approval is lacking in the US, limiting U.S. market penetration.
• Trials and data submissions are ongoing in some jurisdictions to expand approvals for aquaculture (fish treatments) and neglected tropical diseases.

Patent landscape and generic competition

• The original patent by Novartis expired in 2018 in many jurisdictions.
• Generic manufacturing has commenced in developing countries, often at substantially lower prices, affecting revenue in those markets.
• Limited patent protection restricts pricing power and profits in most regions.

Production and supply chain

• Manufacturing focuses on active pharmaceutical ingredient (API) supply, with increased capacity driven by demand from endemic regions.
• Risks include sourcing raw materials, regulatory approvals, and quality control in generic manufacturing.

Competition and alternative therapies

• No direct branded competition exists for fascioliasis treatment.
• The main competitors include off-label use of other anti-parasitic drugs or combination therapies, which are less effective.

Public health and funding initiatives

• WHO's inclusion of triclabendazole in the WHO Model List of Essential Medicines boosts procurement.
• Funding from government and non-governmental organizations sustains demand for MDA programs.

What are the financial prospects and trends?

Revenue projections

• The market is expected to grow at a compound annual growth rate (CAGR) of around 3-4% through 2028.
• The growth is driven largely by expansion in endemic regions and increased awareness.

Key revenue sources

• Patent expiry has allowed generic manufacturers to capture market share, depressing prices.
• Novartis' revenues from Egaten are estimated at USD 20-30 million annually, primarily from Europe, Latin America, and Asia.

Cost considerations

• Manufacturing costs are relatively low, but R&D expenses for new indications or formulations are significant.
• Regulatory compliance costs can restrict smaller players' entry into new markets.

Investment and R&D outlook

• No significant pipeline developments for triclabendazole are publicly announced.
• Focus remains on optimizing existing formulations and expanding approvals.

What future trends could shape the market?

Regulatory expansion

• Approval for use in additional countries and indications can unlock new revenue streams.

Novel formulations

• Development of combination therapies or extended-release formulations could improve treatment adherence and efficiency.

Market penetration in neglected tropical disease (NTD) programs

• Increased global funding directed toward NTDs may sustain or boost demand.

Competition from other antiparasitics

• Growth of generic options is likely to pressure prices unless new formulations or indications emerge.

Environmental and safety considerations

• Focus on environmental impact, such as residue in aquaculture, might influence manufacturing and approval processes.

Key Takeaways

• Triclabendazole has a niche market, primarily driven by endemic disease prevalence and WHO recommendations.
• The patent expiry and generic manufacturing have reduced profit margins but expanded access.
• Growth relies on regulatory approval expansions and public health funding.
• Limited pipeline activity suggests market stability, with growth potential tied more to geographic and indication expansion than innovation.
• Prices are expected to decline further in markets where generics dominate, but demand in endemic regions remains stable.

FAQs

1. Is triclabendazole approved for use in the United States?
No, it is not approved by the FDA. Its use is limited to countries with regulatory approvals for specific indications.

2. Who are the main manufacturers of triclabendazole?
Original development by Novartis; generic manufacturers in India, China, Argentina, and other countries now produce it.

3. What are the main diseases treated with triclabendazole?
Fascioliasis and paragonimiasis, caused by liver and lung flukes respectively.

4. What is the outlook for patent protection?
The primary patent expired in 2018, leading to increased generic competition and price erosion.

5. How does public funding affect market growth?
Funding from WHO and NGOs supports MDA programs, stabilizing demand in endemic regions.

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References

[1] World Health Organization. (2022). Neglected Tropical Diseases: Fascioliasis.
[2] Novartis. (2019). Egaten (triclabendazole) product information.
[3] MarketsandMarkets. (2023). Anti-Parasitic Drugs Market by Type, Application, and Region.
[4] U.S. Food and Drug Administration. (2021). Inclusion of antiparasitic drugs in drug approval pipeline.
[5] European Medicines Agency. (2022). Approval status of triclabendazole.