SKLICE Drug Patent Profile

Which patents cover Sklice, 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. Nineteen 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
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for SKLICE

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

P02CF	Avermectines
P02C	ANTINEMATODAL AGENTS
P02	ANTHELMINTICS
P	Antiparasitic products, insecticides and repellents

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

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)
New Zealand	609247	Preservative system for emulsion-based therapeutic topical formulations
Japan	5694944
Australia	2016201858	PRESERVATIVE SYSTEM FOR EMULSION-BASED THERAPEUTIC TOPICAL FORMULATIONS
Japan	2012507545

Supplementary Protection Certificates for SKLICE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	PA2015033	Lithuania		PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113	92915	Luxembourg		PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
1620113	CA 2015 00045	Denmark		PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: 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
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