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Last Updated: April 16, 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.

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

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
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
Teva Pharms Usa	IVERMECTIN	ivermectin	CREAM;TOPICAL	210019-001	Sep 13, 2019	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	Y			⤷ 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
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	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

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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	⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Canada	2522579	FORMULATION A USAGE TOPIQUE D'IVERMECTINE POUR LE TRAITEMENTDE CONDITIONS DERMATOLOGIQUES (TOPICAL FORMULATION OF IVERMECTIN FOR THE TREATMENT OF DERMATOLOGICAL CONDITIONS)	⤷ Try a Trial
China	1777433	Topical formulation of ivermectin for the treatment of dermatological conditions	⤷ Try a Trial
Russian Federation	2633076	ЛЕЧЕНИЕ ПАПУЛОПУСТУЛЕЗНОЙ РОЗАЦЕА ИВЕРМЕКТИНОМ (PAPULOPUSTULAR ROSACEA TREATMENT BY IVERMECTIN)	⤷ Try a Trial
European Patent Office	3019174	TRAITEMENT DE LA ROSACÉE PAPULO-PUSTULEUSE À L'IVERMECTINE (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)	⤷ Try a Trial
Chile	2016000009	Tratamiento de rosacea papulopustular con ivermectina.	⤷ Try a Trial
Japan	2016523968	イベルメクチンによる丘疹膿疱性の酒さの治療	⤷ Try a Trial
Australia	2004231323	Topical formulation of ivermectin for the treatment of dermatological conditions	⤷ Try a Trial
>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	⤷ 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	CA 2015 00045	Denmark	⤷ Try a Trial	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	⤷ 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	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	92915	Luxembourg	⤷ Try a Trial	PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
1620113	C20150035 00175	Estonia	⤷ Try a Trial	PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
1620113	15C0069	France	⤷ Try a Trial	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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