ERGAMISOL Drug Patent Profile

Which patents cover Ergamisol, and when can generic versions of Ergamisol launch?

Ergamisol is a drug marketed by Janssen Pharma and is included in one NDA.

The generic ingredient in ERGAMISOL is levamisole hydrochloride. There are three drug master file entries for this compound. Additional details are available on the levamisole hydrochloride profile page.

Summary for ERGAMISOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	106
Patent Applications:	5,709
DailyMed Link:	ERGAMISOL at DailyMed

US Patents and Regulatory Information for ERGAMISOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharma	ERGAMISOL	levamisole hydrochloride	TABLET;ORAL	020035-001	Jun 18, 1990		DISCN	No	No

Expired US Patents for ERGAMISOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	ERGAMISOL	levamisole hydrochloride	TABLET;ORAL	020035-001	Jun 18, 1990

International Patents for ERGAMISOL

See the table below for patents covering ERGAMISOL around the world.

Country	Patent Number	Title	Estimated Expiration
France	2196172
Australia	5910573
Philippines	9277	METHOD OF AIDING THE REGRESSION OF NEOPLASTIC DISEASE WITH 2,3,5,6-TETRAHYDRO-6-PHENYLIMIDAZO(2,1-B)THIAZOLE
Germany	2340632
South Africa	7305606
Belgium	803718

ERGAMISOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ergamisol

Introduction

Ergamisol, also known as levamisole, is a medication with a diverse range of applications, including veterinary use as an anthelmintic and human use in various medical conditions. Here, we will delve into the market dynamics and financial trajectory of Ergamisol, highlighting its pricing, usage, and market trends.

Historical Pricing and Cost Comparison

One of the most striking aspects of Ergamisol is the significant price disparity between its human and veterinary formulations. A study published in JAMA Internal Medicine revealed that the introductory human price of Janssen’s Ergamisol was $5 per 50-mg tablet, which is 100 times the veterinary price for an equivalent amount[1].

Market Segmentation and Usage

Human Use

Ergamisol has been used in human medicine for conditions such as immunodeficiency and as an adjuvant in cancer treatment. However, its use has been limited due to the availability of alternative treatments and concerns over its efficacy and safety. The high cost of the human formulation, as mentioned earlier, further restricts its widespread adoption.

Veterinary Use

In veterinary medicine, Ergamisol is widely used as an anthelmintic to treat parasitic infections in animals. The lower cost and established efficacy in this sector make it a preferred choice for veterinarians.

Impact of Misinformation and Market Demand

In recent years, the demand for Ergamisol, particularly in its veterinary formulation, has been influenced by misinformation. During the COVID-19 pandemic, there was a surge in demand for ivermectin and other medications, including Ergamisol, due to false claims about their efficacy in treating COVID-19. This led to a significant increase in the price of veterinary formulations of these drugs, with the price of ivermectin increasing 15-fold over a month[1].

Financial Trajectory

Pricing Ratios

The financial trajectory of Ergamisol is marked by high pricing ratios when comparing human to veterinary formulations. The median human Average Retail Price (ARP) to pet price ratio for Ergamisol and similar medications was found to be 5.5, with a significant number of medications having a ratio of more than 10[1].

Revenue and Market Size

While specific revenue figures for Ergamisol alone are not readily available, the broader market for anthelmintics and immunomodulators provides context. The global pharmaceutical market, including segments where Ergamisol is used, continues to grow driven by increasing healthcare needs and technological advancements.

Regulatory Landscape

The regulatory environment plays a crucial role in the financial trajectory of any drug. For Ergamisol, regulatory approvals and pricing controls can significantly impact its market dynamics. In the human healthcare sector, stringent regulations and the need for extensive clinical trials can delay market entry and increase costs, contributing to higher prices[3].

Competitive Landscape

Ergamisol faces competition from other anthelmintics and immunomodulators in both human and veterinary markets. In the veterinary sector, it competes with other established anthelmintics, while in human medicine, it faces competition from newer, more targeted therapies. The competitive pressure can influence pricing and market share, particularly if alternative treatments offer better efficacy or safety profiles.

Technological Advancements and Innovation

Technological advancements in drug formulation and delivery systems can impact the market dynamics of Ergamisol. For instance, the growing preference for non-invasive treatment methods, such as topical drug delivery systems, could potentially reduce demand for oral or injectable medications like Ergamisol[3].

Geographical Dominance

The market for Ergamisol is influenced by geographical factors, with different regions having varying demands and regulatory environments. In the veterinary sector, regions with large livestock industries may have higher demand for Ergamisol, while in human medicine, demand is more dispersed and influenced by local healthcare policies and economic conditions.

Future Outlook

The future outlook for Ergamisol is complex and influenced by several factors:

• Regulatory Changes: Stricter regulations or changes in pricing policies could impact the cost and availability of Ergamisol.
• Technological Innovations: Advances in drug delivery and formulation could lead to more efficient and cost-effective alternatives.
• Market Demand: Changes in demand due to public health needs or misinformation could fluctuate the market dynamics.

Key Takeaways

• Ergamisol exhibits significant price disparities between human and veterinary formulations.
• Market demand can be influenced by misinformation and public health crises.
• The drug faces competition from other treatments in both human and veterinary sectors.
• Regulatory and technological factors play crucial roles in its financial trajectory.
• Geographical demand varies based on regional healthcare needs and economic conditions.

FAQs

What is Ergamisol used for?

Ergamisol, or levamisole, is used as an anthelmintic in veterinary medicine and as an immunomodulator in human medicine.

Why is there a significant price difference between human and veterinary Ergamisol?

The price difference is largely due to the higher costs associated with human clinical trials, regulatory approvals, and marketing, compared to the lower costs and simpler regulatory pathways for veterinary use.

How has misinformation impacted the market for Ergamisol?

Misinformation, particularly during the COVID-19 pandemic, led to increased demand for veterinary formulations of Ergamisol and other medications, resulting in significant price increases.

What are the key factors influencing the financial trajectory of Ergamisol?

Key factors include regulatory environments, technological advancements, competitive landscape, and geographical demand.

What is the future outlook for Ergamisol?

The future outlook is influenced by potential regulatory changes, technological innovations, and fluctuations in market demand due to public health needs or misinformation.

Sources

1. Price Comparison of Human and Veterinary Formulations of Commonly Prescribed Medications. JAMA Internal Medicine.
2. Testimony of Manon Ress on behalf of the Union for Affordable Cancer Treatment. USITC.
3. Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031 Globally at 6.3% CAGR. Verified Market Research.
4. The Truth About Britain's 'Flesh-Eating' Cocaine. VICE.