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EGATEN Drug Patent Profile

When do Egaten patents expire, and when can generic versions of Egaten launch?

Egaten is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in EGATEN is triclabendazole. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the triclabendazole profile page.

Summary for EGATEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	1
Patent Applications:	1,323
What excipients (inactive ingredients) are in EGATEN?	EGATEN excipients list
DailyMed Link:	EGATEN at DailyMed

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

Constraining patent/regulatory exclusivity:

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

NDA:

208711

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 EGATEN

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4

See all EGATEN clinical trials

Pharmacology for EGATEN

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

US Patents and Regulatory Information for EGATEN

EGATEN is protected by zero US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on INDICATED FOR THE TREATMENT OF FASCIOLIASIS IN PATIENTS 6 YEARS OF AGE AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

EGATEN Market Analysis and Financial Projection Experimental

Liver Fluke Treatment Market Dynamics and Financial Trajectory for Egaten (Triclabendazole)

Introduction to Egaten (Triclabendazole)

Egaten, also known as triclabendazole, is a crucial drug in the treatment of liver fluke infections, particularly those caused by Fasciola hepatica. This medication has garnered significant attention in recent years due to its efficacy and the growing need for effective liver fluke treatment solutions.

Market Approval and Regulatory Landscape

In January 2021, Novartis received USFDA approval for Egaten (triclabendazole) for patients six years of age and older in the United States. This approval marked a significant milestone, as it expanded the treatment options available for liver fluke infections in North America[1][4].

Market Impact of Egaten Approval

The approval of Egaten has had a positive impact on the liver fluke treatment market, particularly in North America. The rise in the number of drug approvals in this region is expected to drive growth, as it addresses the increasing demand for effective and safe treatment solutions. This trend is part of a broader effort by several players in the market to develop and launch novel therapeutic drugs with minimal side effects[1][4].

Competitive Landscape

The liver fluke treatment market is highly competitive, with several major players including Novartis AG, GlaxoSmithKline PLC, Elanco (Bayer AG), Endo International PLC (Par Pharmaceutical), and others. Novartis, with its recent FDA approval for Egaten, has strengthened its position in this market. The competitive landscape is characterized by continuous innovation and the launch of new products, which drives market growth and competition[4].

Regional Market Dynamics

North America

North America holds a significant share of the global liver fluke treatment market, largely due to the increasing prevalence of Fasciola hepatica infections and the approval of new drugs like Egaten. The region's market is driven by the need for effective treatments and the presence of major pharmaceutical companies[1][4].

Asia-Pacific

While North America currently holds the largest market share, the Asia-Pacific region is estimated to grow at the highest CAGR over the forecast period. This growth is driven by increasing cases of liver fluke infections in countries such as China, Japan, and India, as well as improving healthcare infrastructure and access to treatments[4].

Financial Performance and Investment

Novartis, the manufacturer of Egaten, has demonstrated strong financial performance in recent years. In 2013, Novartis reported net sales of USD 57.9 billion, with a significant portion attributed to its pharmaceutical division. The company has sustained high levels of investment in research and development, which has been crucial for the development and approval of new drugs like Egaten[2].

Research and Development

Novartis invests heavily in R&D, with 17% of its Group sales dedicated to this area. This investment has led to a rich pipeline of potential new products, including breakthrough therapies. The approval of Egaten is a testament to this commitment to innovation and science-based development[2].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the liver fluke treatment market, including disruptions in production, supply chains, and clinical trials. However, the market has shown resilience, and the approval of new drugs like Egaten has helped mitigate some of these effects. As the healthcare sector recovers, the demand for liver fluke treatments is expected to increase, driving market growth[4].

Future Trends and Opportunities

The liver fluke treatment market is poised to grow at a CAGR of 4.2% during the forecast period. Several factors contribute to this growth, including increasing cases of liver fluke infections, advancements in treatment options, and expanding healthcare access in emerging markets. The approval of Egaten and similar drugs is expected to continue driving this growth, especially in regions with high prevalence rates[4].

Key Takeaways

• Market Approval: Egaten (triclabendazole) received USFDA approval in January 2021, expanding treatment options for liver fluke infections in North America.
• Market Impact: The approval has driven growth in the North American market, addressing the increasing demand for effective and safe treatments.
• Competitive Landscape: The market is highly competitive, with Novartis strengthening its position through the approval of Egaten.
• Regional Dynamics: North America holds a significant market share, while the Asia-Pacific region is expected to grow at the highest CAGR.
• Financial Performance: Novartis's strong financial performance and significant R&D investments have been crucial for the development and approval of Egaten.
• Future Trends: The market is expected to grow at a CAGR of 4.2%, driven by increasing cases of liver fluke infections and advancements in treatment options.

FAQs

What is Egaten (triclabendazole), and what is it used for?

Egaten, also known as triclabendazole, is a drug used for the treatment of liver fluke infections, particularly those caused by Fasciola hepatica.

When did Egaten receive FDA approval?

Egaten received USFDA approval in January 2021 for patients six years of age and older in the United States.

How has the approval of Egaten impacted the liver fluke treatment market?

The approval of Egaten has driven growth in the North American market by addressing the increasing demand for effective and safe treatment solutions.

Which region holds the largest market share in the liver fluke treatment market?

In 2024, North America accounts for the largest market share in the liver fluke treatment market.

What is the expected growth rate of the liver fluke treatment market?

The liver fluke treatment market is expected to grow at a CAGR of 4.2% during the forecast period.

Sources

1. Mordor Intelligence: Liver Fluke Treatment Market Trends.
2. Annual Reports: Novartis Group Annual Report 2013.
3. Minnesota.gov: Statistical Reports and State Budget Forecasts.
4. Mordor Intelligence: Liver Fluke Treatment Market Size & Share Analysis - Growth Trends.
5. Rethink Priorities: Priority review vouchers for tropical diseases: Impact, distribution.