Levamisole hydrochloride - Generic Drug Details

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

Levamisole hydrochloride is the generic ingredient in one branded drug marketed by Janssen Pharma 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 levamisole hydrochloride.

Summary for levamisole hydrochloride

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	32
DailyMed Link:	levamisole hydrochloride at DailyMed

Recent Clinical Trials for levamisole hydrochloride

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

Sponsor	Phase
International Centre for Diarrhoeal Disease Research, Bangladesh	PHASE2
Cures Within Reach	PHASE2
Institut de Recherche pour le Developpement	PHASE2

See all levamisole hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for levamisole hydrochloride

Adjuvants, Immunologic

Antinematodal Agents

Antirheumatic Agents

Anatomical Therapeutic Chemical (ATC) Classes for levamisole hydrochloride

P02CE	Imidazothiazole derivatives
P02C	ANTINEMATODAL AGENTS
P02	ANTHELMINTICS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for levamisole hydrochloride

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 levamisole hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	ERGAMISOL	levamisole hydrochloride	TABLET;ORAL	020035-001	Jun 18, 1990	4,584,305

Market Dynamics and Financial Trajectory for Levuamisole Hydrochloride

Last updated: February 15, 2026

Overview

Levuamisole hydrochloride, originally developed as an antihelminthic agent, has seen expanding applications from veterinary medicine to potential immunomodulatory and anticancer uses. Its market trajectory depends on regulatory approvals, research developments, competitive landscape, and patent status. Currently, it lacks widespread market penetration for oncological or immunological indications, with most sales confined to veterinary segments.

Regulatory Status and Approvals

• Veterinary Use: Approved in the United States and several other countries for controlling parasitic infestations in livestock. U.S. FDA status dates back to the 1960s for such use.
• Human Use: No FDA approval for treating human conditions; limited clinical research exists suggesting potential immune-modulating properties. Lack of regulatory approval constrains large-scale pharmaceutical adoption.

Patent and Intellectual Property

• Patent Landscape: The composite patent life has expired or is nearing expiration in multiple jurisdictions. No recent patents specifically protect novel formulations or new indications.
• Implications: The patent expiry facilitates generic manufacturing but poses challenges for brands seeking exclusivity unless new formulations or uses are patented.

Market Size and Segments

Segment	Current Market Size	Growth Rate (CAGR 2022–2027)	Key Factors
Veterinary Antihelminthic	~$500 million	2.5%	Established demand; commoditized market
Human Clinical Research	N/A	N/A	Limited; primarily investigational
Immunology/Oncology	N/A	Potential growth	Pending clinical validation

• Veterinary Market: Expected modest growth, driven by increasing livestock production and demand for anti-parasitic treatments.
• Human Markets: Minimal current sales; potential depends on clinical validation and regulatory approvals.

Research and Development Trends

• Preclinical Studies: Focus on immune modulation and anticancer effects. Some phase I/II trials have explored levuamisole as an adjunct in chemotherapy protocols.
• Clinical Trials: Sparse; no recent large-scale Phase III trials registered globally. The clinical pipeline is limited, curbing revenue prospects.

Competitive Landscape

• Existing Drugs: Drugs such as albendazole, ivermectin dominate antihelminthic markets with patent protections and established manufacturing.
• Emerging Candidates: Immune checkpoint inhibitors and targeted therapies advance in oncology, overshadowing repurposing opportunities for levuamisole without significant clinical data.
• Generic Competition: Multiple manufacturers produce levuamisole as a generic drug, reducing pricing power.

Financial Trajectory

• Revenue Trends: Revenue primarily from veterinary sales; human applications remain exploratory with negligible commercial impact.
• Price Points: Veterinary formulations are low-cost, with price sensitivity influencing market penetration.
• Research Investment: Limited investments due to absence of lucrative patent protections and minimal clinical evidence.

Future Outlook

• Positives: Potential for niche immunomodulatory or adjuvant use if clinical trials prove efficacy.
• Negatives: Patent expirations, market saturation in veterinary sector, and competition from newer therapies diminish financial prospects.

Key Challenges

• Lack of regulatory approval for human indications.
• Limited clinical data supporting new uses.
• Price erosion in veterinary market due to generics.
• Competition with established and innovative therapies.

Key Opportunities

• Intellectual property extensions via formulation patents.
• Investigations into combinatorial oncology regimens.
• Potential niche markets in veterinary immunology.

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Key Takeaways

• Levuamisole hydrochloride's current revenue derives mainly from veterinary antihelminthic use.
• Its clinical pipeline for human indications is sparse; no recent large-scale trials are ongoing.
• Patent expiry diminishes exclusivity chances but allows generic market operations.
• Future growth hinges on clinical validation of immunomodulatory or anticancer benefits.
• Market barriers include regulatory hurdles, competition, and limited patent protections.

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FAQs

1. Can Levuamisole Hydrochloride be approved for human cancer treatment?

   Currently, no. Clinical evidence is limited, and regulatory agencies have not approved it for oncology uses.

2. What factors influence its market growth in veterinary medicine?

   Demand for parasite control, generic competition, and pricing sensitivity primarily drive veterinary sales.

3. Are there ongoing clinical trials exploring new indications?

   Few, with most research in early-phase studies or preclinical testing. No large-scale trials announced recently.

4. How does patent expiration impact its market value?

   Patent expiration permits generic manufacturing, reducing prices and profit margins. It also diminishes marketing exclusivity.

5. What strategic moves could expand its market?

   Developing novel formulations, securing patents for new uses, and conducting clinical trials could unlock new revenue streams.

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Sources

1. FDA drug approval history and veterinary use documentation.
2. Global pharmaceutical market reports (MarketResearch.com).
3. Clinical trial registries (clinicaltrials.gov).
4. Patent databases (USPTO, EPO).
5. Industry analyses (EvaluatePharma, IQVIA Reports).