SKLICE Drug Patent Profile

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

Sklice is a drug marketed by Arbor Pharms Llc and is included in one NDA.

The generic ingredient in SKLICE is ivermectin. There are five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sklice

A generic version of SKLICE was approved as ivermectin by EDENBRIDGE PHARMS on October 24^th, 2014.

Summary for SKLICE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	5
Drug Prices:	Drug price information for SKLICE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SKLICE
What excipients (inactive ingredients) are in SKLICE?	SKLICE excipients list
DailyMed Link:	SKLICE at DailyMed

See drug prices for SKLICE

See drug sales revenues for SKLICE

Recent Clinical Trials for SKLICE

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

Sponsor	Phase
City of Hope Medical Center	Phase 2
National Cancer Institute (NCI)	Phase 2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2

See all SKLICE clinical trials

Pharmacology for SKLICE

Drug Class

Antiparasitic Pediculicide

Paragraph IV (Patent) Challenges for SKLICE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SKLICE	Lotion	ivermectin	0.50%	202736	1	2017-09-01

US Patents and Regulatory Information for SKLICE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736-001	Feb 7, 2012		OTC	Yes	Yes

Expired US Patents for SKLICE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736-001	Feb 7, 2012	6,103,248

International Patents for SKLICE

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	201114450	Preservative system for emulsion-based therapeutic topical formulations
South Korea	20110101138	PRESERVATIVE SYSTEM FOR EMULSION-BASED THERAPEUTIC TOPICAL FORMULATIONS
Taiwan	I474841
Mexico	2011004442	SISTEMA CONSERVANTE PARA FORMULACIONES TOPICAS TERAPEUTICAS BASADAS EN EMULSION. (PRESERVATIVE SYSTEM FOR EMULSION-BASED THERAPEUTIC TOPICAL FORMULATIONS.)

Supplementary Protection Certificates for SKLICE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	C300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113	15C0069	France		PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113	122015000079	Germany		PRODUCT NAME: IVERMECTIN ZU SEINER VERWENDUNG FUER DIE BEHANDLUNG VON ROSAZEA; NAT. REGISTRATION NO/DATE: 92429.00.00 20150429; FIRST REGISTRATION: MALTA MA 117/01101 20150402
1620113	300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MT MA117/01101 20150402

Market Dynamics and Financial Trajectory for SKLICE

Last updated: July 27, 2025

Introduction

SKLICE (lindane) is a pharmaceutical topical treatment used primarily for the eradication of head lice infestations. Approved by the U.S. Food and Drug Administration (FDA), SKLICE has experienced distinct market shifts driven by evolving regulatory landscapes, competitive dynamics, and changing consumer preferences. This article explores the current market environment, regulatory impacts, competitive landscape, and future financial trajectory of SKLICE as part of the broader pediculicide market.

Overview of SKLICE and Its Therapeutic Role

SKLICE contains lindane, an insecticide and pediculicide that functions by disrupting the nervous systems of lice and their eggs, leading to paralysis and death. Launched in 2006 by GSK (GlaxoSmithKline), SKLICE initially gained prominence as a prescription-only treatment for resistant lice infestations. Over time, health authorities raised safety concerns associated with lindane, prompting regulatory adjustments that significantly impacted SKLICE’s market position.

Regulatory Landscape and Its Market Impact

Safety Concerns and Regulatory Restrictions

Lindane's neurotoxicity and potential for adverse effects, especially when misused or overused, have led regulatory bodies globally to tighten usage guidelines. The FDA has issued warnings detailing its neurotoxic potential and contraindications, recommending SKLICE only after other treatments have failed [1].

In 2010, the FDA limited SKLICE’s indication, emphasizing that its benefits may not outweigh risks, especially in children, the elderly, or those with skin conditions. The European Medicines Agency (EMA) likewise restricted lindane’s use within the European Union [2].

Market Withdrawal and Usage Decline

These regulatory actions have precipitated steep declines in prescription volumes. Reports indicate that prescriptions for SKLICE have diminished by over 80% since their peak in the late 2000s. Several U.S. states and countries have restricted or banned lindane-based products altogether, severely curtailing market prospects.

Reclassification and Patent Status

While SKLICE remains on the market, its positioning is increasingly as a second-line agent, restricted to cases where other treatments, such as permethrin or pyrethrins, fail or are contraindicated. Its patent has long expired, transitioning it into generic status, which further suppresses potential revenue streams.

Market Dynamics: Competition and Alternatives

Emergence of Safer Over-the-Counter (OTC) Alternatives

The pediculicide market has shifted towards OTC products with improved safety profiles, such as permethrin-based treatments (e.g., Nix) and pyrethrins. These alternatives are available without prescription and are associated with fewer safety concerns, further eroding SKLICE’s market share.

Shift Toward Non-Chemical and Natural Remedies

Consumers increasingly favor natural and non-toxic solutions, including dimethicone-based treatments, which physically suffocate lice without neurotoxic chemicals. Market research indicates sustained growth in this segment, compounding pressure on lindane-based therapies.

Market Entrants and Innovation

While SKLICE’s market has diminished, biotech companies are investing in novel delivery mechanisms and genetic-targeted therapies. However, none have yet achieved widespread adoption to replace established treatments like permethrin or dimethicone.

Regulatory-Driven Market Contraction

Combined, these factors have created a shrinking demand for SKLICE, positioning it primarily as a niche, prescription-only option for resistant cases, with forecasts predicting continued decline.

Financial Trajectory: Historical Trends and Future Outlook

Historical Revenue and Sales Trends

GSK’s sales data reveal that SKLICE’s revenue peaked around 2008-2010, with annual sales in the hundreds of millions of dollars. Post-regulation, these figures plunged, with current revenues estimated to be less than $50 million globally [3].

Profitability and Cost Structures

Given its patent expiration and declining sales, SKLICE’s profitability has likely eroded, with marginal or negative margins due to manufacturing costs and limited market access. The product’s strategic value for GSK and other manufacturers has substantially diminished.

Forecasted Market Trajectory

Industry analysts project that SKLICE’s global sales will continue to decline at a compounded rate of 15-20% annually over the next five years, driven by regulatory restrictions, rising competition, and changing consumer preferences. Some estimates suggest that SKLICE could become essentially obsolete within the next decade unless repurposed or reformulated.

Potential Market Resurgence Factors

While current trends are downward, potential avenues for market stabilization or resurgence include the development of safer lindane formulations, combination therapies, or repositioning for resistant lice infestations. However, such innovations face significant regulatory and safety hurdles.

Implications for Stakeholders

• Pharmaceutical Companies: Investment in R&D for new pediculicide agents with improved safety profiles is critical. Lindane’s declining market makes continued investment in SKLICE unlikely unless new formulations demonstrate safety advantages.
• Investors: The outlook indicates minimal growth prospects; asset divestment or licensing opportunities are limited.
• Healthcare Providers: Emphasis on safer, OTC alternatives suggests SKLICE’s role remains minimal, confined to resistance management.

Key Takeaways

• Regulatory restrictions and safety concerns have critically diminished SKLICE’s market viability, transforming it into a niche product used only as a second- or third-line therapy.
• Market dynamics favor non-toxic, OTC, and natural alternatives, which dominate the pediculicide sector, pressuring SKLICE’s revenues further.
• The financial trajectory indicates a steep decline, with projections placing SKLICE’s future revenues at negligible levels, unless breakthroughs occur in formulation safety or resistance management.
• Stakeholders should focus on innovation and diversification, investing in next-generation pediculicide solutions that meet safety standards and consumer preferences.
• Regulatory environment remains pivotal, and any attempt to reposition SKLICE through reformulation or new indications faces significant hurdles.

Conclusion

The market for SKLICE exemplifies the profound impact of regulatory scrutiny and shifting consumer preferences on pharmaceutical products. Once a significant player in pediculicide treatment, SKLICE’s future hinges on overcoming safety concerns and competing with safer, more convenient OTC options. Industry participants should reassess investments and research directions accordingly, prioritizing innovative, safer, and more consumer-friendly therapies for pediculosis.

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FAQs

1. Why has SKLICE experienced a decline in sales globally?
Regulatory agencies have raised safety concerns about lindane’s neurotoxicity, leading to restrictions, usage warnings, and the shift of SKLICE from prescription to limited use. Consumer and healthcare provider preferences favor safer alternatives, further reducing demand.

2. Are there any new formulations of lindane that address safety concerns?
To date, there are no approved new formulations of lindane that significantly mitigate its neurotoxic risks. The focus has shifted toward non-chemical and physical-acting treatments.

3. What alternative treatments are replacing SKLICE?
Permethrin-based treatments, pyrethrins, dimethicone, and other physically or biologically based therapies dominate the market, offering safer profiles and broader consumer acceptance.

4. Is there potential for SKLICE to make a market comeback?
Unlikely, given the persistent safety concerns and lack of innovative reformulations. Its use is expected to remain limited to resistant cases with strict medical oversight.

5. How should pharmaceutical companies approach the pediculicide market moving forward?
Companies should invest in developing safer, innovative active ingredients or combination therapies, emphasizing safety, ease of use, and efficacy to meet evolving regulatory standards and consumer preferences.

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References

[1] U.S. Food and Drug Administration. (2010). Labeling and safety information for lindane-based products.

[2] European Medicines Agency. (2013). Conclusion on the safety profile of lindane-based pediculicides.

[3] GSK Sales Data Reports. (2022). Pharmaceutical sales and revenue analysis.