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Last Updated: February 27, 2021

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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 Perrigo Uk Finco, Teva Pharms Usa, Galderma Labs Lp, Taro, Arbor Pharms Llc, Edenbridge Pharms, and Merck Sharp Dohme, and is included in seven NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ivermectin has one hundred and one patent family members in twenty-nine countries.

There are five drug master file entries for ivermectin. Eight suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for ivermectin

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Recent Clinical Trials for ivermectin

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

SponsorPhase
Public Health Laboratory Ivo de Carneri, Chake Chake, Pemba, Zanzibar, TanzaniaPhase 2/Phase 3
Coordinación de Investigación en Salud, MexicoPhase 3
Gilberto Cruz ArteagaPhase 3

See all ivermectin clinical trials

Generic filers with tentative approvals for IVERMECTIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.5%LOTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ivermectin
Medical Subject Heading (MeSH) Categories for ivermectin
Paragraph IV (Patent) Challenges for IVERMECTIN
Tradename Dosage Ingredient NDA Submissiondate
SKLICE LOTION;TOPICAL ivermectin 202736 2017-09-01
SOOLANTRA CREAM;TOPICAL ivermectin 206255 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
Arbor Pharms Llc SKLICE ivermectin LOTION;TOPICAL 202736-001 Feb 7, 2012 OTC Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Arbor Pharms Llc SKLICE ivermectin LOTION;TOPICAL 202736-001 Feb 7, 2012 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 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

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

Supplementary Protection Certificates for ivermectin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 C 2015 036 Romania   Start 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 PA2015033,C1620113 Lithuania   Start 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 15C0069 France   Start Trial PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113 92915 Luxembourg   Start Trial PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
1620113 PA2015033 Lithuania   Start Trial 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   Start Trial PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: 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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