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Last Updated: June 21, 2024

Ivermectin - Generic Drug Details


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What are the generic drug sources for ivermectin and what is the scope of freedom to operate?

Ivermectin is the generic ingredient in four branded drugs marketed by Padagis Israel, Teva Pharms Usa, Zydus Lifesciences, Galderma Labs Lp, Taro, Arbor Pharms Llc, Edenbridge Pharms, and Merck Sharp Dohme, and is included in nine NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ivermectin has seventy-seven patent family members in twenty-eight countries.

There are five drug master file entries for ivermectin. Nineteen suppliers are listed for this compound.

Drug Prices for ivermectin

See drug prices for ivermectin

Recent Clinical Trials for ivermectin

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

SponsorPhase
National Public Health Institute of LiberiaPhase 2
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, UgandaPhase 3
Insel Gruppe AG, University Hospital BernPhase 2

See all ivermectin clinical trials

Pharmacology for ivermectin
Medical Subject Heading (MeSH) Categories for ivermectin
Paragraph IV (Patent) Challenges for IVERMECTIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SKLICE Lotion ivermectin 0.50% 202736 1 2017-09-01
SOOLANTRA Cream ivermectin 1% 206255 1 2016-12-30

US Patents and Regulatory Information for ivermectin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Taro IVERMECTIN ivermectin LOTION;TOPICAL 210720-001 May 6, 2020 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zydus Lifesciences IVERMECTIN ivermectin CREAM;TOPICAL 215210-001 Aug 2, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Padagis Israel IVERMECTIN ivermectin CREAM;TOPICAL 210225-001 Apr 13, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ivermectin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Arbor Pharms Llc SKLICE ivermectin LOTION;TOPICAL 202736-001 Feb 7, 2012 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ivermectin

Country Patent Number Title Estimated Expiration
Israel 243314 טיפול בנגעים דלקתיים של רוזצאה על ידי איוורמקטין (Treatment of inflammatory lesions of rosacea with ivermectin) ⤷  Sign Up
Canada 2916704 TRAITEMENT DES LESIONS INFLAMMATOIRES CAUSEES PAR LA ROSACEE A L'IVERMECTINE (TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN) ⤷  Sign Up
New Zealand 716033 Treatment of papulopustular rosacea with ivermectin ⤷  Sign Up
China 111467301 使用伊维菌素治疗丘疹脓疱性红斑痤疮 (Treatment of papulopustular rosacea with ivermectin) ⤷  Sign Up
South Korea 20160061310 이버멕틴을 사용한 주사의 염증성 병변 치료 (TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN) ⤷  Sign Up
China 103800353 Topical application of ivermectin for the treatment of dermatological conditions/afflictions ⤷  Sign Up
South Korea 101187231 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ivermectin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 2015/046 Ireland ⤷  Sign Up PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
1620113 C20150035 00175 Estonia ⤷  Sign Up PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
1620113 PA2015033 Lithuania ⤷  Sign Up PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113 C300756 Netherlands ⤷  Sign Up PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113 C 2015 036 Romania ⤷  Sign Up 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
1620113 56/2015 Austria ⤷  Sign Up PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
1620113 15C0069 France ⤷  Sign Up PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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