Permethrin - Generic Drug Details

What are the generic drug sources for permethrin and what is the scope of freedom to operate?

Permethrin is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Usa, Actavis Labs, Dr Reddys Labs Eu, Encube Ethicals, Padagis Israel, Glaxosmithkline, Medtech Products, Actavis Mid Atlantic, and Perrigo New York, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for permethrin. Fifteen suppliers are listed for this compound.

Summary for permethrin

US Patents:	0
Tradenames:	3
Applicants:	9
NDAs:	9
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	32
Patent Applications:	5,706
Drug Prices:	Drug price trends for permethrin
Drug Sales Revenues:	Drug sales revenues for permethrin
What excipients (inactive ingredients) are in permethrin?	permethrin excipients list
DailyMed Link:	permethrin at DailyMed

See drug prices for permethrin

See drug sales revenues for permethrin

Recent Clinical Trials for permethrin

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

Sponsor	Phase
Universitas Padjadjaran	Phase 4
Alliance Pharmaceuticals	N/A
STATKING Clinical Services	Phase 4

See all permethrin clinical trials

Pharmacology for permethrin

Drug Class

Pyrethroid

Medical Subject Heading (MeSH) Categories for permethrin

Enzyme Inhibitors

Insecticides

Anatomical Therapeutic Chemical (ATC) Classes for permethrin

P03AC	Pyrethrines, incl. synthetic compounds
P03A	ECTOPARASITICIDES, INCL. SCABICIDES
P03	ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for permethrin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs	PERMETHRIN	permethrin	CREAM;TOPICAL	074806-001	Jan 23, 1998	AB	RX	No	No
Glaxosmithkline	NIX	permethrin	LOTION;TOPICAL	019435-001	Mar 31, 1986		DISCN	No	No
Dr Reddys Labs Eu	PERMETHRIN	permethrin	CREAM;TOPICAL	209732-001	Aug 1, 2023		DISCN	No	No
Padagis Israel	PERMETHRIN	permethrin	CREAM;TOPICAL	076369-001	Apr 21, 2003	AB	RX	No	Yes
Encube Ethicals	PERMETHRIN	permethrin	CREAM;TOPICAL	211303-001	Apr 3, 2019	AB	RX	No	No

Expired US Patents for permethrin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	NIX	permethrin	LOTION;TOPICAL	019435-001	Mar 31, 1986	4,024,163
Medtech Products	NIX	permethrin	LOTION;TOPICAL	019918-001	May 2, 1990	4,024,163

Market Dynamics and Financial Trajectory for Permethrin: A Comprehensive Analysis

Last updated: July 28, 2025

Introduction

Permethrin, a synthetic pyrethroid insecticide, has established a multifaceted presence in the pharmaceutical, agricultural, and consumer sectors. Predominantly utilized in the treatment of parasitic skin conditions such as scabies and head lice, permethrin's favorable safety profile, efficacy, and resistance profile have sustained its market relevance. This analysis explores the evolving market dynamics and financial trajectory of permethrin, emphasizing regulatory shifts, competitive landscape, manufacturing trends, and therapeutic applications.

Market Overview and Therapeutic Applications

Permethrin's primary pharmaceutical applications involve topical treatments for ectoparasitic infestations. Its acceptance stems from broad-spectrum activity against pests such as Sarcoptes scabiei and Pediculus humanus capitis. Globally, the demand is driven by increasing prevalence of parasitic infections, rising awareness, and the cost-effectiveness of permethrin-based therapies.

Beyond pharmaceuticals, permethrin dominates in vector control programs, notably against malaria and dengue vectors, especially in tropical regions. The compound's dual role as both a human therapeutic agent and an insecticide in public health campaigns influences overall market dynamics.

Regulatory Landscape and Market Entry Barriers

The regulatory environment significantly shapes permethrin's commercial viability. Agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and similar bodies in emerging markets regulate its pharmaceutical formulations. Permethrin-based products for pediculosis—like Nix®—have achieved over-the-counter (OTC) status in many regions, facilitating widespread access.

Conversely, regulatory hurdles related to safety assessments, particularly concerning neurotoxicity concerns from animal studies, have impacted newer formulations' approval processes. The legacy of regulatory standards influences research and development investment, affecting the pace of innovation and market expansion.

Competitive Landscape and Patent Dynamics

Permethrin's generic status in many markets has intensified price competition, pressuring profit margins for manufacturers. Leading brands such as Johnson & Johnson's Nix® and Pediculicide formulations from other pharmaceutical companies face competition mainly from unbranded generics.

Patent expirations for initial formulations have enabled market entry for generic producers, shifting revenue predominantly toward cost-effective, non-branded products. Limited patent protections for current formulations restrict innovation-driven differentiation, confining the market to price competition.

Manufacturing and Supply Chain Considerations

Global supply chains for permethrin rely on key production hubs primarily in China and India. The quality of manufacturing and regulatory compliance across suppliers directly influence product safety and efficacy, affecting market reputation.

Recent disruptions, such as the COVID-19 pandemic, temporarily impacted raw material availability and distribution channels, underscoring the importance of supply chain resilience for sustained market performance. Additionally, environmental concerns about the persistence and potential ecological impacts of pyrethroids have prompted shifts toward more sustainable manufacturing practices.

Market Drivers and Barriers

Drivers

• Rising Incidence of Parasitic Diseases: Increased prevalence in developing countries escalates demand for permethrin-based treatments.
• Regulatory Approvals for OTC Use: Streamlined access in key markets propels sales volume.
• Public Health Campaigns: Vector control initiatives support permethrin use in mosquito nets and sprays.
• Growing Awareness and Self-Medication: Consumer familiarity with permethrin products enhances OTC sales.

Barriers

• Resistance Development: Emerging resistance among lice and mites diminishes treatment efficacy, prompting the search for alternative products.
• Safety Concerns: Neurotoxicity reports influence regulatory tightening and consumer perceptions.
• Environmental Impact: Regulatory scrutiny on pyrethroids can restrict certain applications, affecting the broader market.

Financial Trajectory: Revenue Trends and Market Forecasts

Historical data indicate stable growth in permethrin-based pharmaceuticals, driven by endemic parasitic conditions in emerging markets. The global pediculicide market, in particular, was valued at approximately USD 300 million in 2020, with an anticipated compound annual growth rate (CAGR) of around 4% through 2030 [1].

Emerging markets, such as India and Brazil, dominate sales due to high prevalence rates and lower product costs. Conversely, developed markets exhibit slower growth, shifted toward generics and OTC formulations.

Major pharmaceutical firms are incentivized to diversify applications, especially in vector control, where permethrin formulations face expanding regional adoption. The growth in institutional procurement for public health programs promises sustained revenue streams.

However, patent expirations and increasing competition are exerting downward pressure on prices, constraining margins. The transition toward more sustainable and low-toxicity pyrethroids may impact future formulations' market share.

Projected Financial Trends

• Moderate Growth in Pharmaceutical Applications: Sustained demand in endemic regions anticipates a CAGR of 3-5% over the next decade.
• Expanding Vector Control Revenue: Growing investments in malaria and dengue prevention, especially in Africa and Southeast Asia, could contribute to approximately 6-8% CAGR.
• Impact of Resistance and Safety Issues: Potentially limit market expansion unless novel formulations or resistant pest management strategies are developed.

Innovation and Future Outlook

Research efforts focus on developing permethrin derivatives with enhanced efficacy and reduced resistance potential. Nanoformulations and combination therapies are gaining interest. Regulatory bodies are increasingly emphasizing environmental safety, encouraging innovation toward environmentally benign pyrethroids.

Pharmacoeconomic shifts favor integrated pest and parasite management strategies, potentially transforming permethrin's market from standalone products toward comprehensive solutions.

Conclusion

Permethrin remains a pivotal agent in parasitic disease treatment and vector control. While existing market dynamics demonstrate steady growth driven by endemic disease prevalence and public health initiatives, vulnerabilities such as resistance development, regulatory constraints, and low innovation rates pose challenges.

The future of permethrin's market depends on sustainable manufacturing practices, adaptive regulatory responses, and innovative formulations that address resistance and safety concerns. Strategic investments in R&D and diversified application portfolios will be critical for producers seeking to capitalize on evolving market opportunities.

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Key Takeaways

• Stable Demand in Endemic Regions: Developing countries exhibit persistent needs for permethrin-based therapies due to high parasitic infection rates.
• Regulatory and Patent Effects: OTC regulatory approvals in key markets facilitate access but competition from generics limits margins.
• Environmental and Resistance Challenges: Resistance among pests and environmental concerns threaten future market growth unless addressed through innovation.
• Public Health Impact: Vector control initiatives significantly influence permethrin's demand, especially in malaria-endemic regions.
• Business Strategy Implication: Diversification into new formulations, sustainable manufacturing, and tailored regional strategies are essential for long-term profitability.

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FAQs

1. How does resistance affect permethrin's effectiveness in treating parasitic infections?
Resistance reduces permethrin's efficacy by enabling pests and mites to survive standard treatments, necessitating higher doses or alternative therapies, which can lead to increased costs and reconsideration of its clinical role.

2. What are the environmental concerns associated with permethrin?
Permethrin's persistence in the environment can harm aquatic life and non-target organisms, prompting regulatory scrutiny and calls for environmentally safer pyrethroids.

3. Are there innovations underway to overcome permethrin resistance?
Yes, research explores permethrin derivatives, synergists, and nanotechnology-based formulations to enhance efficacy and mitigate resistance development.

4. How significant is the OTC segment in permethrin's pharmaceutical market?
OTC products constitute a major segment, especially in developed markets, facilitating widespread access and boosting sales volumes.

5. What emerging markets show potential for permethrin market expansion?
Regions such as Africa, Southeast Asia, and Latin America are poised for growth due to increasing disease burdens and public health campaigns.

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Sources:
[1] Market Research Future. "Pediculicide Market Analysis," 2021.