When do the patents on EGATEN expire, and when will generic EGATEN be available?

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4

Subscribe to access the full database, or Start Trial
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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: September 26, 2026

Egaten, Novartis’ brand of triclabendazole, is a specialized anti-infective used primarily to treat fascioliasis caused by liver flukes. Its commercial profile differs from conventional pharmaceutical products: demand is concentrated in endemic countries, procurement is driven by public-health programs, and a significant share of supply is donated. Novartis does not separately report Egaten revenue, so the product’s financial trajectory cannot be measured from public company filings as a standalone sales line.

The market has durable medical demand but limited commercial scale. Growth depends on disease-control programs, diagnostic expansion, government procurement and donor commitments rather than broad retail prescribing. Triclabendazole has limited direct therapeutic competition for fascioliasis, but generic manufacturing, public procurement pricing and donation-based access constrain pricing power.

What is Egaten and what disease does it treat?

Egaten is the brand name for triclabendazole, a benzimidazole anthelmintic. It is used to treat fascioliasis, a parasitic infection caused by Fasciola hepatica and Fasciola gigantica. The infection affects the liver and biliary tract and is transmitted through contaminated water or food.

The World Health Organization identifies fascioliasis as a neglected tropical disease. Human cases are concentrated in parts of Latin America, the Middle East, Africa and Asia, with transmission linked to livestock, freshwater vegetation and inadequate sanitation (World Health Organization, 2023).

Triclabendazole has a more specific role than most anthelmintics because it is active against both immature and adult liver flukes. WHO has recommended it as the treatment of choice for human fascioliasis. That position supports continued demand even though the total addressable market is small compared with mass-market anti-infective categories.

Egaten product profile

Attribute	Detail
Brand	Egaten
Active ingredient	Triclabendazole
Drug class	Benzimidazole anthelmintic
Primary indication	Fascioliasis
Principal manufacturer	Novartis
Main customer base	Ministries of health, public-health agencies, hospitals and humanitarian procurement programs
Typical access model	Donation, tender supply and limited commercial distribution
Direct competition	Limited for fascioliasis; generic triclabendazole is the main commercial risk
U.S. FDA approval	February 13, 2019
U.S. application	NDA 212270
Biosimilar relevance	None; Egaten is a small-molecule drug

How large is the Egaten market?

The Egaten market is medically important but financially niche. The relevant market is not equivalent to the entire global population at risk of fascioliasis. Effective demand depends on diagnosis, confirmed infection, treatment access and national procurement budgets.

Three factors limit market size:

Fascioliasis is geographically concentrated.
Many infections are undiagnosed or treated outside formal health systems.
Novartis has historically supplied substantial volumes through donation programs rather than normal commercial sales.

Novartis announced a long-term commitment to donate Egaten for the treatment of fascioliasis. The company has worked with WHO to supply the medicine to endemic countries, including through large-scale public-health distribution programs (Novartis, 2023; World Health Organization, 2023).

Publicly available sources do not provide an audited global Egaten sales figure. Novartis annual reports generally include Egaten within broader categories or corporate responsibility and access activities rather than disclosing product-level revenue. As a result, market-sizing claims that assign a precise annual Egaten revenue figure are not supported by company reporting.

Demand drivers

The principal demand drivers are:

Government recognition of fascioliasis as a public-health priority.
WHO treatment recommendations.
Expanded diagnostic testing.
School and community screening in endemic regions.
Outbreak response.
Procurement by ministries of health and international health agencies.
Substitution away from less effective or off-label treatments.
Increased reporting of infection in migrant and rural populations.

Demand is structurally recurring because fascioliasis transmission persists in endemic agricultural areas. It is not, however, a high-frequency chronic-treatment market. Most patients receive a short treatment course, and procurement volumes fluctuate with epidemiological campaigns and donor schedules.

What is the financial trajectory of Egaten?

Egaten’s financial trajectory is best described as stable public-health demand with limited disclosed commercial monetization. The product is unlikely to be a material contributor to Novartis consolidated revenue.

Novartis’ commercial portfolio is dominated by large brands such as Entresto, Cosentyx, Kisqali and Kesimpta. Egaten occupies a different strategic category: it supports neglected-disease access and corporate responsibility objectives while maintaining a specialized supply position.

Financial profile

Financial factor	Expected effect on Egaten
Unit demand	Stable to gradually increasing in endemic programs
Price	Constrained by government tenders and donation commitments
Revenue visibility	Low because product-level sales are not separately disclosed
Gross-margin potential	Limited by access pricing, donated supply and low volume
Commercial scalability	Low without major expansion of diagnosis and treatment programs
Strategic value	Higher in public-health access and reputation than in reported revenue
Forecast volatility	High because orders depend on tenders, grants and campaigns
Cannibalization risk	Low because direct substitutes are limited
Generic pressure	Moderate to high where quality-assured generic supply is available

The likely near- to medium-term outcome is not rapid revenue expansion. A more realistic trajectory is modest volume growth, flat or constrained realized pricing and continued reliance on institutional procurement. If Novartis expands donation commitments, treated-patient volume may increase without a corresponding increase in recognized revenue.

How does Novartis monetize Egaten?

Egaten is supplied through a mixed model:

Donated product for public-health programs.
Institutional supply to governments and international organizations.
Commercial sales in selected markets.
Tender-based procurement in countries with formal anti-parasitic programs.

This model creates a difference between epidemiological growth and financial growth. More patients may receive treatment, but that does not necessarily produce proportionate sales growth for Novartis.

Donation programs can reduce commercial pricing pressure by preserving Novartis’ role as the principal branded supplier. They also make the product central to national treatment strategies. The trade-off is that donated volumes do not generate conventional pharmaceutical revenue.

Novartis’ annual reporting does not identify Egaten as a separate revenue-generating franchise. No public filing provides a standalone Egaten forecast, operating margin or product-level earnings target (Novartis, 2024).

What is the FDA regulatory status of Egaten?

The FDA approved Egaten tablets on February 13, 2019, for the treatment of fascioliasis in patients aged six years and older weighing at least 30 kilograms. The approval made triclabendazole the first FDA-approved treatment specifically indicated for fascioliasis in the United States (U.S. Food and Drug Administration, 2019).

The U.S. market is small because fascioliasis is uncommon domestically. U.S. demand is concentrated in:

Imported cases.
Patients with travel or migration histories.
Patients from endemic regions.
Specialist infectious-disease treatment.
Public-health and hospital procurement.

FDA approval improved regulatory certainty and treatment access. It did not create a large commercial market because U.S. disease prevalence remains low.

FDA market implications

The approval gives Novartis a regulated reference product in the United States. It also establishes labeling, dosing and safety information that generic competitors would need to match through an abbreviated new drug application or another applicable pathway.

The commercial value of U.S. approval is therefore greater for regulatory credibility and institutional access than for sales volume.

What is the Orange Book status of Egaten?

Egaten is a small-molecule prescription drug and may be evaluated through the FDA’s Orange Book framework. The principal exclusivity issue is regulatory exclusivity rather than a strong, long-lived composition-of-matter patent estate.

Triclabendazole is an old active ingredient. Its original compound protection, if any, would have expired long before the 2019 U.S. approval. The key protection associated with the U.S. launch was the approval itself, including any applicable new-chemical-entity or orphan-drug exclusivity, rather than a newly invented active molecule.

Publicly available product information does not support treating Egaten as a product protected by a broad, unexpired composition patent. Later patents could potentially address formulation, dosage, manufacturing or other technical features, but those rights would not necessarily prevent a generic from marketing a materially different formulation that satisfies FDA requirements.

When does Egaten lose exclusivity?

The relevant exclusivity period depends on the designation and approval pathway reflected in FDA records. The 2019 approval created a period of regulatory protection, but the practical generic-entry date also depends on any orphan designation, pediatric exclusivity, listed patents and the timing of ANDA approvals.

A five-year new-chemical-entity exclusivity period would have extended from February 13, 2019, into February 2024. If FDA granted orphan-drug exclusivity for the approved indication, the seven-year period could extend into February 2026. The commercial significance of the remaining protection is limited by the small U.S. market and the possibility of generic entry in other jurisdictions that do not recognize equivalent exclusivity.

The public record does not establish a broad patent barrier that would support a long extension of Egaten exclusivity beyond regulatory periods.

What generic entry risks exist for Egaten?

Generic risk is moderate to high over the long term, especially outside the United States. The active ingredient is established, the clinical use is well characterized and the dosage form is relatively conventional.

Generic entry faces several practical barriers:

Limited market size may not justify regulatory development costs.
Demand is concentrated in low- and middle-income countries.
Government buyers may favor established donation channels.
Quality-assured manufacturing and regulatory compliance are required.
Procurement contracts may be irregular.
WHO or national treatment programs may require prequalification or documented quality standards.

The same factors that reduce generic commercial interest also protect Novartis from rapid erosion. A large generic manufacturer could still enter if it secures government tenders, international procurement contracts or a supply agreement with a global health organization.

Paragraph IV challenge risk

A Paragraph IV challenge would be relevant only if an ANDA applicant identifies an unexpired FDA-listed patent and alleges that the patent is invalid, unenforceable or will not be infringed. The commercial basis for such a challenge appears limited unless an active formulation, method-of-use or manufacturing patent is listed.

Because the active ingredient is old, a generic applicant would likely focus on regulatory approval, bioequivalence and supply economics rather than challenge a foundational molecule patent. Public sources do not identify a major Egaten Paragraph IV litigation campaign.

What patent protection covers Egaten?

The strongest historical protection for triclabendazole would have related to the original active compound and its early pharmaceutical development. That protection is no longer the principal commercial barrier.

Potential later protection could include:

Tablet formulation.
Particle-size or solid-state characteristics.
Manufacturing and purification processes.
Combination therapy.
Dosing regimens.
Use in particular patient populations.
Packaging or stability improvements.

These rights would have narrower scope than a composition patent. A formulation patent may protect one version of a product without blocking all triclabendazole tablets. A method-of-use patent may cover a specific treatment protocol without preventing a generic from selling the active ingredient for other approved uses.

No broad, publicly established patent estate presently supports an assumption that Egaten has long-term exclusivity comparable to a new molecular entity launched with an active composition patent.

What competitive landscape affects Egaten?

The competitive landscape has two levels: clinical substitutes and supply substitutes.

Clinical competition

Triclabendazole is the preferred therapy for fascioliasis. Other anthelmintics, including albendazole and praziquantel, do not provide an equivalent substitute across the full disease lifecycle. Nitazoxanide and other agents have been studied or used in certain circumstances, but they do not have the same position in international treatment guidance.

This gives Egaten strong clinical differentiation despite its narrow market.

Supply competition

Supply competition is more relevant than therapeutic competition. Potential competitors include:

Generic triclabendazole manufacturers.
Regional pharmaceutical companies.
Public-sector manufacturers.
International procurement suppliers.
Alternative branded or unbranded products in countries with weaker regulatory controls.

Novartis benefits from brand recognition, FDA approval, WHO relationships and experience supplying endemic-country programs. Generic competitors could compete effectively on price if they achieve consistent quality and regulatory acceptance.

What manufacturing and intellectual-property barriers affect Egaten?

Manufacturing triclabendazole tablets is technically less difficult than producing a biologic or complex drug-delivery system. The principal barriers are commercial and regulatory rather than scientific.

A credible supplier must demonstrate:

Consistent active pharmaceutical ingredient quality.
Control of impurities and polymorphic form.
Validated tablet manufacturing.
Stability across hot and humid climates.
Reliable packaging and distribution.
Compliance with local regulatory standards.
Capacity to fulfill irregular but potentially large public tenders.

These requirements can discourage small manufacturers. They do not, however, create an insurmountable barrier for established generic companies.

What is the outlook for Egaten revenue and market share?

Egaten’s volume outlook is more favorable than its revenue outlook.

Base case

Novartis continues public-health donations and institutional supply. Treated-patient volumes rise gradually as diagnosis improves, while recognized revenue remains flat or grows slowly.

Upside case

WHO-backed elimination programs, expanded screening and new government funding increase treatment volumes. Novartis retains a leading supply role, but donation economics limit revenue conversion.

Downside case

Generic suppliers win tenders in selected countries, donor funding weakens or procurement shifts toward lower-cost manufacturers. Novartis retains the reference brand but loses institutional volume and pricing power.

The product’s revenue exposure to Novartis is likely immaterial relative to the company’s major pharmaceutical franchises. Its strategic value lies in maintaining access leadership in a neglected disease, supporting regulatory credibility and preserving a trusted supply position.

Key Takeaways

Egaten is Novartis’ triclabendazole product for fascioliasis.
Demand is recurring but concentrated in endemic countries and public-health programs.
Novartis does not separately disclose Egaten revenue, preventing a verified standalone financial forecast.
The product’s donation model increases treatment access but limits direct revenue growth.
FDA approval was granted on February 13, 2019, under NDA 212270.
Triclabendazole’s original compound protection is not the primary current barrier to entry.
Generic risk is moderate to high over time, particularly outside the United States.
Clinical substitution is limited because triclabendazole is the preferred therapy for fascioliasis.
Supply competition, tender pricing and donor procurement are more important than therapeutic competition.
Egaten is strategically relevant to Novartis’ access portfolio but is unlikely to be a material consolidated revenue driver.

FAQs

Is Egaten a blockbuster drug?

No. Egaten addresses a narrow neglected-disease market and is not reported as a major Novartis revenue franchise.

Is triclabendazole available as a generic?

Generic triclabendazole may be available in some countries, but availability, quality standards and regulatory approval vary by jurisdiction.

Does Egaten have biosimilar competition?

No. Egaten is a small-molecule drug, so the relevant competitors are generic-drug manufacturers rather than biosimilar developers.

Can Egaten be used to treat other parasitic infections?

Its approved and guideline-supported role is primarily fascioliasis. Use for other parasites depends on local labeling, clinical evidence and physician judgment.

Why does Novartis continue supplying a low-revenue drug?

Egaten supports neglected-disease access programs and provides Novartis with an established role in global health procurement, even though its direct financial contribution is limited.

References

Novartis AG. (2023). Annual report 2023. Basel, Switzerland: Author.
Novartis AG. (2024). Annual report 2023 and corporate reporting materials. Basel, Switzerland: Author.
U.S. Food and Drug Administration. (2019). FDA approves first treatment for fascioliasis. Silver Spring, MD: U.S. Department of Health and Human Services.
World Health Organization. (2023). Fascioliasis. Geneva, Switzerland: Author.
World Health Organization. (2023). WHO guideline for the control and elimination of human fascioliasis. Geneva, Switzerland: Author.

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	1
What excipients (inactive ingredients) are in EGATEN?	EGATEN excipients list
DailyMed Link:	EGATEN at DailyMed

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

AI Deep Research

Questions you can ask:

Summary for EGATEN

Recent Clinical Trials for EGATEN

Pharmacology for EGATEN