Ivermectin - Generic Drug Details

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, 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.

Summary for ivermectin

International Patents:	77
US Patents:	12
Tradenames:	4
Applicants:	8
NDAs:	9
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	201
Patent Applications:	7,385
Formulation / Manufacturing:	see details
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
Universitas Padjadjaran	Phase 4
Galvita AG, Switzerland	Early Phase 1
University Children's Hospital Basel	Early Phase 1

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

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
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes			Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes
Merck Sharp Dohme	STROMECTOL	ivermectin	TABLET;ORAL	050742-001	Nov 22, 1996		DISCN	Yes	No
Teva Pharms Usa	IVERMECTIN	ivermectin	CREAM;TOPICAL	210019-001	Sep 13, 2019	AB	RX	No	No
Edenbridge Pharms	IVERMECTIN	ivermectin	TABLET;ORAL	204154-001	Oct 24, 2014	AB	RX	No	No

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
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014

International Patents for ivermectin

Country	Patent Number	Title	Estimated Expiration
South Africa	201600358	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN
Poland	378932	Zastosowanie ivermectiny do leczenia schorzeń dermatologicznych (TOPICAL FORMULATION OF IVERMECTIN FOR THE TREATMENT OF DERMATOLOGICAL CONDITIONS)
Japan	2021059590	イベルメクチンを用いた、酒さの炎症性病変の治療 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
Japan	2016523968	イベルメクチンによる丘疹膿疱性の酒さの治療
Chile	2016000009	Tratamiento de rosacea papulopustular con ivermectina.
Brazil	112016000350	métodos de tratamento de lesões inflamatórias da rosácea e usos de uma composição farmacêutica

Supplementary Protection Certificates for ivermectin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	C 2015 036	Romania		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	15C0069	France		PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113	C01620113/01	Switzerland		PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
1620113	CA 2015 00045	Denmark		PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
1620113	122015000079	Germany		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	PA2015033,C1620113	Lithuania		PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402