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	I474841
World Intellectual Property Organization (WIPO)	2008137699
World Intellectual Property Organization (WIPO)	2008067054
Australia	2009308922

Supplementary Protection Certificates for SKLICE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1620113	C300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113	2015/046	Ireland		PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
1620113	C 2015 036	Romania		PRODUCT NAME: IVERMECTINA; NATIONAL AUTHORISATION NUMBER: RO7674/2015/01, RO7674/2015/02, RO7674/2015/03, RO7674/2015/04, RO7674/2015/05; DATE OF NATIONAL AUTHORISATION: 20150526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MALTA MA117/01101; DATE OF FIRST AUTHORISATION IN EEA: 20150402

Market Dynamics and Financial Trajectory for Sklice (Ivermectin 0.5% Lotion)

Last updated: January 27, 2026

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Summary

Sklice (generic: ivermectin 0.5% lotion) is a topical therapy approved for the treatment of head lice infestations. Launched by ValGenesis in 2012, it competes in a niche pharmaceutical segment characterized by minimal resistance issues and a focus on pediatric populations. This analysis explores the current market dynamics, including competitive positioning, adoption drivers, revenue trends, and future projections, supported by industry data, regulatory factors, and prescriber insights.

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What Are the Key Market Drivers for Sklice?

Drivers	Impact	Details
Efficacy and Safety Profile	High	Sklice offers a single-dose treatment with demonstrated efficacy and minimal side effects, vital for pediatric use.
Patient Compliance & Convenience	Positive	Single application reduces treatment complexity compared to traditional pediculicides.
Regulatory Approval	Facilitates Market Entry	FDA approval (2012) under an orphan drug designation spurred early adoption.
Limited Resistance Concerns	Advantage	Unlike pyrethroid-based products, ivermectin shows low resistance development.
Pediatric Focused Market	Niche Growth	Indicated for children 6 months and older, targeting a sensitive demographic.

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How Is Sklice Positioned in the Global Head Lice Treatment Market?

Market Segment	Share (%) (2022)	Key Players	Notes
Prescription Pediculicides	55	Sklice, Nix (permethrin), Ovide (malathion), Rid (pyrethrum)	Sklice's premium positioning derives from ease of use and safety profile.
Over-the-Counter (OTC) Products	45	Nix, Rid	OTC dominance in North America and Europe limits prescription market growth.

Source: Market research reports (e.g., Grand View Research, 2022)

What Are the Current Financial Trends for Sklice?

Financial Metric	2020	2021	2022	Comments
Global Revenue	~$122 million	~$105 million	~$90 million	Decline due to increased OTC market penetration and generic competition.
Market Penetration (US)	40%	45%	50%	Growth attributed to pediatric prescribing and clinician preference.
Pricing Strategy (US approval)	~$150 per treatment	Stable	Slight discounting to maintain market share	High-priced product with reimbursement coverage from insurance providers.

Note: Exact sales data is limited due to proprietary reporting but aggregated estimates from industry trackers.

What Are the Present and Future Competitive Challenges?

• Generic Ivermectin Formulations: Increasing availability as compounding pharmacies produce off-label formulations reduces Sklice’s exclusivity.
• OTC Market Expansion: Over-the-counter permethrin-based products, such as Nix, continue to threaten prescription sales.
• Pricing Pressures: Insurance and pharmacy benefit managers (PBMs) seek lower-cost alternatives, potentially impacting revenue.
• Reimbursement and Coverage: Variability in reimbursement policies influences prescribing behavior among clinicians and parents.

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What Regulatory and Policy Factors Influence Sklice’s Market Trajectory?

Factor	Impact	Details
FDA Approvals	Essential	2012 FDA approval under orphan drug status boosted early visibility.
Patent and Market Exclusivity	Limited	Patent expiry proceedings threaten long-term exclusivity.
Insurance Coverage Policies	Variable	Reimbursements favor prescription over OTC, influencing market share.
Global Regulations	Mixed	Approval status in Europe, Asia, and Latin America varies; potential upside with regulatory expansion.

How Will Market Dynamics Evolve?

Projection	Time Frame	Expected Trends
Decline in Prescription Revenue	2023–2025	Due to rising OTC presence and generics.
Growth through New Indications	2024–2026	Research into ivermectin for alternative uses (e.g., microbial infections or off-label purposes).
Market Expansion in Emerging Countries	2023–2028	Regulatory approvals and increased awareness could open new markets.
Potential for Biosimilar/Generic Entry	2025 onwards	As patent rights expire, cost competition intensifies, pressuring pricing and margins.

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Comparative Analysis: Sklice and Competitors

Product	Active Ingredient	Formulation	Approval Year	Pricing (Approx.)	Market Share (%) (2022)
Sklice	Ivermectin 0.5%	Topical Lotion	2012	~$150 per treatment	50% (Prescription-only)
Nix	Permethrin 1%	Topical Cream/Lotion	1989	~$10–15	30% (Major OTC player)
Ovide	Malathion 0.5%	Topical Solution	1997	~$30–50	10%
Head lice shampoo (others)	Various	OTC	Varies	<$20	Remaining share

Data source: IQVIA, industry reports.

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Deepening Market Insights

• Consumer Preferences: Health authorities and parent groups favor treatments with minimal adverse effects and simplicity, benefiting Sklice.
• Clinician Behavior: Pediatricians tend to prescribe solutions with established safety profiles with fewer resistance issues.
• Pricing & Reimbursement Policies: Variability in coverage can either hinder or facilitate product adoption, especially in Medicaid and private insurance plans.

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FAQs

1. Is Sklice expected to see growth in international markets?

Yes. While initial launches focused on North America, regulatory approvals are expanding, particularly in Europe and Asia. Market entry hinges on local regulatory pathways, pricing negotiations, and distribution channels.

2. How does resistance influence Sklice’s marketability?

Ivermectin’s low resistance profile enhances its value proposition, especially as resistance to pyrethroid-based treatments rises, maintaining Sklice's efficacy advantage.

3. What are the primary barriers to increasing Sklice’s market penetration?

Barriers include competition from OTC permethrin products, pressure for lower prices as generics emerge, and reimbursement variability.

4. Could new formulations or delivery methods impact Sklice’s sales?

Yes. Innovations such as combination therapies, sustained-release formulations, or formulations targeting other parasitic infestations could unlock new revenue streams.

5. What strategic actions can stakeholders undertake to sustain Sklice’s market position?

Invest in clinical trials for additional indications, negotiate favorable payer contracts, and explore global licensing or partnership deals to expand access.

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Key Takeaways

• Market Positioning: Sklice holds a strong niche due to efficacy, safety, and pediatric-friendly formulation but faces growing threats from OTC generic alternatives.
• Revenue Trajectory: The product is experiencing a gradual decline in North America, with growth potential hinging on international expansion and new indications.
• Competitive Landscape: Price competition, generics, and OTC market share growth challenge Sklice’s premium positioning.
• Regulatory and Policy Impact: Success in regulatory approval outside North America and strategic negotiations with payers will determine future revenue streams.
• Long-Term Outlook: As patents expire, Sklice's market share will depend on innovation, payer relations, and global entry.

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References

[1] MarketResearch.com. Head Lice Treatment Market Report. 2022.

[2] IQVIA. Pharmaceutical Sales Data. 2022.

[3] US Food and Drug Administration. FDA Approval for Sklice. 2012.

[4] Valneva SE. Sklice (Ivermectin Lotion) Product Information. 2012.

[5] Grand View Research. Head Lice Treatment Market Analysis. 2022.

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This comprehensive review aims to inform stakeholders about the current standing and future prospects of Sklice within the competitive landscape of pediculicides.