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 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. Twenty suppliers are listed for this compound.

Summary for ivermectin

International Patents:	77
US Patents:	12
Tradenames:	4
Applicants:	8
NDAs:	9
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	206
Patent Applications:	7,396
Drug Prices:	Drug price trends for ivermectin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ivermectin
What excipients (inactive ingredients) are in ivermectin?	ivermectin excipients list
DailyMed Link:	ivermectin at DailyMed

See drug prices for ivermectin

Recent Clinical Trials for ivermectin

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

Sponsor	Phase
Public Health Laboratory Ivo de Carneri	Phase 2
National Public Health Institute of Liberia	Phase 2
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda	Phase 3

See all ivermectin clinical trials

Pharmacology for ivermectin

Drug Class	Antiparasitic Pediculicide

Medical Subject Heading (MeSH) Categories for ivermectin

Antiparasitic Agents
Insecticides

Anatomical Therapeutic Chemical (ATC) Classes for ivermectin

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 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

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Glossary

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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				⤷ 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
Taro	IVERMECTIN	ivermectin	LOTION;TOPICAL	210720-001	May 6, 2020		OTC	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
>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

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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
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

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Country	Patent Number	Title	Estimated Expiration
Japan	6438466		⤷ Sign Up
Brazil	PI0410503	uso da ivermectina para a fabricação de uma composição farmacêutica tópica, composição tópica e uso da composição	⤷ Sign Up
Chile	2016000009	Tratamiento de rosacea papulopustular con ivermectina.	⤷ Sign Up
Poland	378932	Zastosowanie ivermectiny do leczenia schorzeń dermatologicznych (TOPICAL FORMULATION OF IVERMECTIN FOR THE TREATMENT OF DERMATOLOGICAL CONDITIONS)	⤷ Sign Up
Russian Federation	2005136438	ПРИМЕНЕНИЕ ИВЕРМЕКТИНА ДЛЯ ЛЕЧЕНИЯ ДЕРМАТОЛОГИЧЕСКИХ РАССТРОЙСТВ	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ivermectin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2015 00045	Denmark	⤷ Sign Up	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	C300756	Netherlands	⤷ Sign Up	PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
1620113	PA2015033,C1620113	Lithuania	⤷ Sign Up	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	⤷ 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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