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 Lifesciences, Galderma Labs Lp, Taro, Arbor Pharms Llc, Edenbridge Pharms, Senores Pharms, and Merck Sharp Dohme, and is included in ten 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-one suppliers are listed for this compound.

Summary for ivermectin

International Patents:	77
US Patents:	12
Tradenames:	4
Applicants:	9
NDAs:	10
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	206
Patent Applications:	7,388
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

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			Y
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
Merck Sharp Dohme	STROMECTOL	ivermectin	TABLET;ORAL	050742-001	Nov 22, 1996		DISCN	Yes	No
Zydus Lifesciences	IVERMECTIN	ivermectin	CREAM;TOPICAL	215210-001	Aug 2, 2022	AB	RX	No	No
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			Y

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
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736-001	Feb 7, 2012
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
Israel	243315	טיפול של פאפולוסטר רוסאסיה דרך איברמקטין (Treatment of papulopustular rosacea with ivermectin)
Australia	2004231323	Topical formulation of ivermectin for the treatment of dermatological conditions
South Korea	20160061311	이버멕틴을 사용한 구진농포성 주사의 치료 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
China	1777433	Topical formulation of ivermectin for the treatment of dermatological conditions
Russian Federation	2633076	ЛЕЧЕНИЕ ПАПУЛОПУСТУЛЕЗНОЙ РОЗАЦЕА ИВЕРМЕКТИНОМ (PAPULOPUSTULAR ROSACEA TREATMENT BY IVERMECTIN)
China	105792829	使用伊维菌素治疗丘疹脓疱性红斑痤疮 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
South Korea	101863085

Supplementary Protection Certificates for ivermectin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	C20150035 00175	Estonia		PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
1620113	C01620113/01	Switzerland		PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
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	PA2015033	Lithuania		PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113	300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MT MA117/01101 20150402
1620113	2015/046	Ireland		PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 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

Ivermectin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ivermectin

Market Overview

The global ivermectin market has been experiencing significant growth, driven by various factors including the rise in parasitic infections and its misuse during the COVID-19 pandemic.

• As of 2022, the global ivermectin market valued at USD 293.95 million, and it is projected to reach USD 398.46 million by 2028, with a Compound Annual Growth Rate (CAGR) of 5.2% during the forecast period[1].

Market Drivers

Several key factors are driving the growth of the ivermectin market:

• Prevalence of Parasitic Infections: The increasing prevalence of parasitic infections such as ascariasis, lymphatic filariasis, and river blindness in both humans and animals is a major driver. For instance, in dogs, the prevalence of roundworms, hookworms, and whipworms ranges significantly, necessitating the use of anthelmintic drugs like ivermectin[1].

• Veterinary Use: Ivermectin is widely used in veterinary medicine, which contributes substantially to its market growth. The demand for ivermectin in treating parasitic infections in livestock and pets continues to rise[3].

• Misuse During COVID-19: Although ivermectin has no proven efficacy against COVID-19, its prescriptions surged during the pandemic, leading to significant spending by insurers. This misuse, however, is considered wasteful and not aligned with economic theory or medical evidence[2][5].

Market Segmentation

The ivermectin market is segmented based on several criteria:

• Type: Ivermectin is available in various forms, including powder and liquid, each catering to different applications[3][4].

• Application: The market is divided into human medicine and veterinary medicine. The veterinary segment is particularly robust due to the widespread use of ivermectin in animal health care[3][4].

• Geography: The market is analyzed across different regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics and growth prospects[3][4].

Financial Trajectory

The financial outlook for the ivermectin market is promising but complex due to various factors:

• Global Market Size: The global ivermectin market is expected to grow from USD 293.95 million in 2022 to USD 398.46 million by 2028, with a CAGR of 5.2%[1].

• Regional Markets: The European market, for example, is forecasted to reach USD 213.7 million by 2030, growing at a CAGR of 7.3% from 2024 to 2030[4].

• Wasteful Spending: The misuse of ivermectin for COVID-19 has led to significant wasteful spending by insurers. Estimates suggest that insurers spent nearly $130 million annually on ivermectin prescriptions for COVID-19, which is considered ineffective care[2][5].

Key Players

The ivermectin market is dominated by several key players:

• Merck & Co. Inc.: One of the original developers and major suppliers of ivermectin.
• CSPC Pharmaceutical Group Limited: A significant player in the Asian market.
• Jubilant Life Sciences Ltd.: Known for its extensive range of pharmaceutical products, including ivermectin.
• Boehringer Ingelheim International GmbH: A global pharmaceutical company with a strong presence in the veterinary segment.
• Other notable players include Hero Pharmaceutical, HuBei YuanCheng SaiChuang, ENN, and LAND[3][4].

Market Dynamics

The market dynamics are influenced by several factors:

• Drivers: Increasing demand due to parasitic infections, advancements in pharmaceutical technology, and the expanding veterinary market.
• Restraints: Regulatory challenges, the misuse of ivermectin for COVID-19, and the potential for resistance development in parasites.
• Opportunities: Growing awareness of animal health, expansion into new markets, and the development of new formulations.
• Challenges: Ensuring the responsible use of ivermectin, managing wasteful spending, and addressing regulatory hurdles[3].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the ivermectin market, albeit largely negative:

• Increased Prescriptions: Despite having no proven efficacy against COVID-19, ivermectin prescriptions surged, leading to substantial wasteful spending by insurers.
• Economic Implications: The annual spending on ivermectin for COVID-19 was estimated at $129.7 million, which is higher than spending on some low-value medical services[2][5].

Future Outlook

The future of the ivermectin market looks promising, especially in the veterinary segment:

• Growth Projections: The market is expected to continue growing, driven by the increasing need for effective treatments against parasitic infections.
• Regulatory Measures: There is a need for stricter regulatory measures to prevent the misuse of ivermectin and ensure its responsible use.
• Innovation: The development of new formulations and delivery methods could further boost the market[3][4].

Key Takeaways

• The global ivermectin market is growing, driven by the rise in parasitic infections and veterinary use.
• The misuse of ivermectin for COVID-19 has led to significant wasteful spending.
• Key players dominate the market, and regional markets show varying growth rates.
• Regulatory measures and innovation are crucial for the future growth and responsible use of ivermectin.

FAQs

Q: What is the current market size of the global ivermectin market? A: As of 2022, the global ivermectin market valued at USD 293.95 million[1].

Q: What is the projected growth rate of the ivermectin market? A: The market is expected to grow at a CAGR of 5.2% from 2022 to 2028[1].

Q: Why did ivermectin prescriptions surge during the COVID-19 pandemic? A: Despite having no proven efficacy against COVID-19, ivermectin prescriptions increased significantly, leading to wasteful spending by insurers[2][5].

Q: Who are the major players in the ivermectin market? A: Major players include Merck & Co. Inc., CSPC Pharmaceutical Group Limited, Jubilant Life Sciences Ltd., and Boehringer Ingelheim International GmbH, among others[3][4].

Q: What are the main segments of the ivermectin market? A: The market is segmented by type (powder, liquid), application (human medicine, veterinary medicine), and geography (North America, Europe, Asia-Pacific, etc.)[3][4].

Sources

1. Global Ivermectin Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029 - Market Research.
2. US Insurer Spending on Ivermectin Prescriptions for COVID-19 - JAMA.
3. Global Ivermectin API Sales Market Size, Scope And Forecast Report - Market Research Intellect.
4. Ivermectin - Market, Report Size, Worth, Revenue, Growth, Industry - Valuates Reports.
5. Study: Insurers spend nearly $130M a year on ivermectin prescriptions - Fierce Healthcare.