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Last Updated: June 2, 2020

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SKLICE Drug Profile


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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. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in thirteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Sklice

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

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Drug patent expirations by year for SKLICE
Drug Prices for SKLICE

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Drug Sales Revenue Trends for SKLICE

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Recent Clinical Trials for SKLICE

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

SponsorPhase
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2
bioRASI, LLCPhase 3
Actavis Inc.Phase 3

See all SKLICE clinical trials

Recent Litigation for SKLICE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Arbor Pharmaceuticals, LLC v. Teva Pharmaceuticals USA, Inc.2019-01-09
Arbor Pharmaceuticals, LLC v. Taro Pharmaceuticals U.S.A., Inc.2017-12-15

See all SKLICE litigation

Pharmacology for SKLICE
Paragraph IV (Patent) Challenges for SKLICE
Tradename Dosage Ingredient NDA Submissiondate
SKLICE LOTION;TOPICAL ivermectin 202736 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 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc SKLICE ivermectin LOTION;TOPICAL 202736-001 Feb 7, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SKLICE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 C01620113/01 Switzerland   Start Trial PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
1620113 122015000079 Germany   Start Trial 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   Start Trial PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504
1620113 15C0069 France   Start Trial PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113 C300756 Netherlands   Start Trial PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113 56/2015 Austria   Start Trial PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Boehringer Ingelheim
Colorcon
Medtronic
Harvard Business School

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