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Last Updated: February 26, 2024

Ivermectin - Generic Drug Details


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What are the generic sources for ivermectin and what is the scope of patent protection?

Ivermectin is the generic ingredient in four branded drugs marketed by Padagis Israel, Teva Pharms Usa, Zydus, 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
Universitas PadjadjaranPhase 4
Permamed AG, SwitzerlandEarly Phase 1
Galvita AG, SwitzerlandEarly Phase 1

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Edenbridge Pharms IVERMECTIN ivermectin TABLET;ORAL 204154-001 Oct 24, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro IVERMECTIN ivermectin LOTION;TOPICAL 210720-001 May 6, 2020 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa IVERMECTIN ivermectin LOTION;TOPICAL 212485-001 Mar 21, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Arbor Pharms Llc SKLICE ivermectin LOTION;TOPICAL 202736-001 Feb 7, 2012 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ivermectin

Country Patent Number Title Estimated Expiration
Mexico 2016000122 TRATAMIENTO DE ROSACEA PAPULOPUSTULAR CON INVERMECTINA. (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN.) ⤷  Try a Trial
South Africa 200507346 Topical formulation of ivermectin for the treatment of dermatological conditions ⤷  Try a Trial
Luxembourg 92915 ⤷  Try a Trial
Denmark 1620113 ⤷  Try a Trial
Russian Federation 2016103753 ЛЕЧЕНИЕ ВОСПАЛИТЕЛЬНЫХ ПОВРЕЖДЕНИЙ ПРИ РОЗАЦИА С ПОМОЩЬЮ ИВЕРМЕКТИНА ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004093886 ⤷  Try a Trial
Mexico PA05011208 USO DE IVERMECTINA PARA EL TRATAMIENTO DE DESORDENES DERMATOLOGICOS. (TOPICAL FORMULATION OF IVERMECTIN FOR THE TREATMENT OF DERMATOLOGICAL CONDITIONS.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ivermectin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 122015000079 Germany ⤷  Try a 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 CR 2015 00045 Denmark ⤷  Try a Trial PRODUCT NAME: LVERMECTIN (22,23-DIHYDROAVERMECTIN B1 A + 22,23-DIHYDROAVERMECTIN B1 B); NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
1620113 PA2015033,C1620113 Lithuania ⤷  Try a Trial PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113 2015/046 Ireland ⤷  Try a Trial PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
1620113 C300756 Netherlands ⤷  Try a Trial PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113 C 2015 036 Romania ⤷  Try a Trial 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 300756 Netherlands ⤷  Try a Trial PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MT MA117/01101 20150402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Express Scripts
Harvard Business School
Baxter

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