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-one 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
National Cancer Institute (NCI)	Phase 2
City of Hope Medical Center	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
European Patent Office	2155190	FORMULATIONS TOPIQUES ET PROCÉDÉS D'ÉLIMINATION ET DE PROPHYLAXIE DE SOUCHES DE POUX SUSCEPTIBLES ET RÉSISTANTES AU TRAITEMENT AVEC DE MULTIPLES MODES D'ACTION (TOPICAL FORMULATIONS AND METHODS FOR ELIMINATION AND PROPHYLAXIS OF SUSCEPTIBLE AND TREATMENT RESISTANT STRAINS OF HEAD LICE WITH MULTIPLE MODES OF ACTION)
Canada	2666365	FORMULATIONS TOPIQUES D'AVERMECTINE ET PROCEDES D'ELIMINATION ET DE PROPHYLAXIE DE SOUCHES DE POUX SUSCEPTIBLES ET RESISTANTES AU TRAITEMENT (TOPICAL AVERMECTIN FORMULATIONS AND METHODS FOR ELIMINATION AND PROPHYLAXIS OF SUSCEPTIBLE AND TREATMENT-RESISTANT STRAINS OF HEAD LICE)
Spain	2653259
South Korea	101658116
Taiwan	201114450	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	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	92915	Luxembourg		PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
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	2015/046	Ireland		PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402

SKLICE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sklice (Ivermectin) Lotion

Introduction to Sklice

Sklice, a lotion containing 0.5% ivermectin, is a topical treatment for head lice infestations. Initially approved as a prescription drug in February 2012, it was later approved for nonprescription (over-the-counter) use by the FDA in October 2020[1][3].

Market Size and Growth

The global lice treatment market, within which Sklice operates, was valued at USD 989.90 million in 2022 and is projected to reach USD 1,730.08 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.40%[4].

Regional Market Dominance

North America dominates the global lice treatment market, while the Asia Pacific region is the fastest-growing market segment. This growth is partly driven by increasing awareness and the convenience of retail pharmacies, which have become a preferred distribution channel for lice treatments[4].

Distribution Channels

Retail Pharmacies

The retail pharmacies segment is a major contributor to the lice treatment market, expected to exhibit a CAGR of 6.35% during the forecast period. This segment has seen significant growth due to the COVID-19 pandemic, as more people opt to purchase medications from retail pharmacies rather than visiting hospitals for routine check-ups[4].

Product Features and Market Appeal

Sklice is distinguished by its single, 10-minute treatment application, eliminating the need for a second treatment or painful nit combing. It is gentle on hair and effective against head lice, making it a preferred choice for families with children aged 6 months and older[1][3].

Pricing and Cost Considerations

The cost for Sklice 0.5% topical lotion is approximately $296 for a supply of 117 grams, although prices can vary depending on the pharmacy. Generic versions of ivermectin topical lotion are also available, priced around $176.52 for 117 grams[5].

Patient Assistance and Discounts

To make Sklice more accessible, various discount programs and copay cards are available. For instance, the Drugs.com Discount Card can save consumers up to 80% off the cost of Sklice and other medications[5].

Regulatory Approval and Public Health Impact

The FDA's approval of Sklice for nonprescription use was a significant step in increasing consumer access to effective head lice treatments. This approval process, known as an Rx-to-OTC switch, requires robust data demonstrating the drug's safety and effectiveness when used as directed without healthcare professional supervision[1].

Public Health Benefits

Head lice infestations are common, affecting between 6 and 12 million children in the United States each year. The availability of Sklice over-the-counter expands access to an effective treatment, particularly for families and households where head lice are prevalent[1].

Market Competition

The lice treatment market is competitive, with various products available, including prescription and over-the-counter options. However, Sklice's unique features, such as its single-application treatment and gentle formulation, position it favorably in the market[3].

Financial Trajectory

Revenue Projections

Given the growing demand for lice treatments and the dominance of retail pharmacies as distribution channels, Sklice is likely to see increased revenue. The overall market growth and the convenience of over-the-counter availability will contribute to its financial trajectory.

Cost Savings for Consumers

The availability of generic versions and discount programs will help in making Sklice more affordable for consumers, potentially increasing its market share and revenue.

Key Takeaways

• Market Growth: The global lice treatment market is projected to grow significantly, driven by increasing demand and the convenience of retail pharmacies.
• Product Appeal: Sklice's single-application treatment and gentle formulation make it a preferred choice for families.
• Pricing and Discounts: The product is available at various price points, with generic options and discount programs making it more accessible.
• Regulatory Approval: The FDA's approval for nonprescription use has expanded consumer access to Sklice.
• Public Health Impact: Sklice addresses a common public health issue, providing an effective treatment for head lice infestations.

FAQs

Q: What is Sklice, and how is it used?

A: Sklice is a topical lotion containing 0.5% ivermectin, used to treat head lice infestations. It is applied once for 10 minutes and does not require a second treatment or nit combing[1][3].

Q: Is Sklice available over-the-counter?

A: Yes, Sklice was approved by the FDA for nonprescription (over-the-counter) use in October 2020[1].

Q: How much does Sklice cost?

A: The cost for Sklice 0.5% topical lotion is around $296 for a supply of 117 grams, although generic versions are available at a lower price point of approximately $176.52[5].

Q: What are the benefits of using Sklice?

A: Sklice offers a single, 10-minute treatment application, is gentle on hair, and eliminates the need for painful nit combing. It is effective for children aged 6 months and older[1][3].

Q: Are there any discount programs available for Sklice?

A: Yes, various discount programs and copay cards are available to make Sklice more affordable. For example, the Drugs.com Discount Card can save consumers up to 80% off the cost[5].

Sources

1. FDA Approves Lotion for Nonprescription Use to Treat Head Lice - FDA
2. State Fiscal Year 2021 Print Annual Reviews Quarter 2 - Oklahoma.gov
3. Sklice Lice Treatment - Sklice.com
4. Lice Treatment Market Size, Share and Forecast to 2031 - StraitsResearch
5. Sklice Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com