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, Epic Pharma Llc, Rubicon Research, Senores Pharms, and Merck Sharp Dohme, and is included in twelve NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ivermectin has forty-five patent family members in sixteen countries.

There are five drug master file entries for ivermectin. Twenty-three suppliers are listed for this compound.

Summary for ivermectin

International Patents:	45
US Patents:	5
Tradenames:	4
Applicants:	11
NDAs:	12
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	222
Patent Applications:	6,921
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
Kirby Institute	PHASE3
Medicines Development for Global Health	PHASE3
Murdoch Childrens Research Institute	PHASE3

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
Rubicon Research	IVERMECTIN	ivermectin	TABLET;ORAL	215922-001	Jan 22, 2025	AB	RX	No	No
Padagis Israel	IVERMECTIN	ivermectin	CREAM;TOPICAL	210225-001	Apr 13, 2020	AB	RX	No	No
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	10,206,939
Taro	IVERMECTIN	ivermectin	LOTION;TOPICAL	210720-001	May 6, 2020		OTC	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	7,550,440
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	8,470,788
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	11,033,565
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	8,815,816

International Patents for ivermectin

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1223841	使用伊維菌素治療丘疹膿皰性紅斑痤瘡 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN)
World Intellectual Property Organization (WIPO)	2015006319
Singapore	11201510420U	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN
Russian Federation	2016103715	ЛЕЧЕНИЕ ПАПУЛОПУСТУЛЕЗНОЙ РОЗАЦЕА ИВЕРМЕКТИНОМ

Supplementary Protection Certificates for ivermectin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	C300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; 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	15C0069	France		PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402

Market Dynamics and Financial Trajectory for Ivermectin

Last updated: July 27, 2025

Introduction

Ivermectin, a drug originally developed in the 1970s for parasitic infections, has recently garnered intense global attention due to its controversial application in COVID-19 treatment. While its primary use remains in veterinary medicine and for parasitic diseases, emerging discussions around its off-label use in humans have reshaped its market landscape. This article critically examines the current market dynamics, financial trajectory, and future outlook for ivermectin amid evolving regulatory environments, scientific evidence, and commercial interests.

Historical Context and Medical Applications

Initially approved in the 1980s, ivermectin revolutionized parasitic disease management, notably onchocerciasis (river blindness) and strongyloidiasis. Its safety profile and efficacy enabled mass distribution programs, primarily facilitated by pharmaceutical companies and global health organizations (WHO, 2021). The drug is on the World Health Organization’s List of Essential Medicines, underscoring its public health importance.

In veterinary medicine, ivermectin remains widely used for parasite control in livestock and companion animals, representing a significant revenue stream for pharmaceutical manufacturers such as Merck & Co., which developed ivermectin through its subsidiary, Merck Animal Health.

The COVID-19 Catalyst: Market Disruptions and Controversies

Surge in Off-Label Use and Market Expansion

In 2020-2021, ivermectin emerged as a contentious candidate for COVID-19 treatment. Despite limited robust evidence supporting its efficacy, widespread publicity, fueled by social media and political endorsements, led to a surge in off-label prescription and self-medication. Countries like India, Honduras, and others reported increased demand, straining supply chains and prompting regulatory scrutiny (US FDA, 2021).

Pharmaceutical companies experienced unpredictable market shifts. While some, like Merck & Co., publicly dismissed ivermectin for COVID-19, others supplied the surge in demand, often through off-label channels. This period underscored the drug’s potential as a high-volume, low-cost, off-patent solution—if scientifically validated.

Regulatory and Scientific Developments

Regulatory agencies, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), issued warnings against using ivermectin for COVID-19 outside clinical trials, citing insufficient evidence and potential toxicity. Several high-profile clinical trials yielded mixed or negative results, dampening the initial enthusiasm and realigning the market.

However, some regions continued approving or prescribing ivermectin for COVID-19, influencing local demand dynamics and creating a bifurcated global market. The proliferation of counterfeit and substandard formulations further complicated regulation and safety assessments.

Market Dynamics

Supply Chain Challenges

Demand spikes, combined with logistical constraints, led to shortages in human formulations. The supply of veterinary ivermectin, with its higher manufacturing volume, provided some buffer; however, concerns arose regarding diversion to human use. The global supply chain experienced pressure points due to increased demand, regulatory clampdowns, and manufacturing bottlenecks.

Competitive Landscape

Ivermectin’s generic status means multiple manufacturers produce the drug, resulting in competitive pricing. This low-cost environment initially lowered barriers for widespread adoption, but ongoing debates over efficacy have caused market volatility—a phenomenon typical of off-patent drugs with emergent uses.

Consumer and Prescriber Behavior

Health authorities’ warnings have restrained mainstream medical use, but persistent public interest driven by media and political figures has maintained a segment of demand. In some regions, politicization of ivermectin has led to widespread procurement, including from unregulated sources, which complicates market oversight.

Patent and Legal Issues

Since ivermectin is off-patent, legal disputes over rights are less prominent. Nonetheless, ongoing litigation related to false advertising, safety claims, and regulatory compliance influence the commercial environment, particularly as new formulations or combination therapies are developed.

Financial Trajectory

Revenue Streams and Market Segmentation

Currently, ivermectin’s revenue primarily stems from:

• Veterinary products: Dominant segment, with Merck & Co. leading worldwide.
• Human medicine: Historically minor, but potential growth driven by emerging indications and off-label use.

The COVID-19 episode temporarily boosted sales in some regions. For example, Indian manufacturers, such as Cipla and Sun Pharma, reported increased production, boosting sales volumes. However, this spike was transient, heavily influenced by external factors like media coverage and regulatory stance.

Future Growth Potential

Post-pandemic, the market faces downward pressures due to:

• Weak scientific support for COVID-19 use.
• Regulatory restrictions in key markets.
• Public health initiatives discouraging unapproved therapies.
• Patent sunset for formulations, leading to low pricing and reduced profit margins.

Conversely, ivermectin may sustain a niche market in parasitic and tropical disease treatment, especially in underserved regions. Additionally, ongoing research into new indications or combination therapies could unlock new revenue streams, contingent upon rigorous clinical validation.

Investment and Commercialization Outlook

Pharmaceutical firms are unlikely to pursue ivermectin as a blockbuster COVID-19 treatment without substantiated clinical evidence. However, companies involved in parasitic disease portfolios may maintain or modestly expand production, particularly targeting low-income markets.

Investment in research and development, quality control, and regulatory engagement remains crucial. Companies focusing on formulation innovations—like sustained-release or combination drugs—may find niche markets or respond to emerging antimicrobial resistance challenges.

Legal and Ethical Considerations

While ivermectin’s affordability and availability support its use in global health, misinformation and off-label prescribing pose ethical concerns. Manufacturers face scrutiny over claims and marketing practices—especially when scientific evidence remains inconclusive.

Regulatory agencies continue to monitor and regulate claims, with violations potentially resulting in sanctions, recalls, or legal challenges. Ethical business strategies must align with scientific consensus, emphasizing safety and efficacy.

Price Trends and Market Opportunities

Given its off-patent status, ivermectin's price has historically been low, particularly in bulk veterinary formulations. Market volatility during the COVID-19 pandemic caused transient price increases, but stability is expected to resume. Opportunities exist in developing region-specific formulations, combination therapies, and expanding indications through rigorous clinical research, which could support modest price premium and market differentiation.

Conclusion

Ivermectin’s market landscape is currently characterized by volatility driven by non-scientific factors, regulatory challenges, and its off-label COVID-19 application. Its core remains as a vital antiparasitic agent with a steady demand in veterinary and tropical medicine sectors. The future financial trajectory hinges on scientific validation for new indications, regulatory responses, and ethical marketing practices.

Key takeaways:

• Ivermectin’s market is heavily influenced by non-scientific demand spikes, especially during the COVID-19 pandemic.
• The core market remains in anti-parasitic and tropical medicine applications, with stable long-term demand.
• Regulatory restrictions and scientific evidence are critical determinants of future market potential.
• Patent expiration and low production costs constrain profitability, but niche development may offer incremental opportunities.
• Ethical considerations and regulatory compliance are vital for sustainable market growth.

FAQs

1. Will ivermectin become a widely accepted COVID-19 treatment?
Current clinical evidence does not support ivermectin as an effective COVID-19 therapy; therefore, it is unlikely to achieve widespread acceptance without new, rigorous data. Regulatory agencies remain cautious.

2. How does ivermectin's patent status affect its market potential?
Being off-patent drives low prices and broad accessibility but limits high-margin opportunities. Innovation and new indications are necessary for extended commercial viability.

3. What are the main risks for pharmaceutical companies involved with ivermectin?
Regulatory bans, safety concerns, misinformation campaigns, and reputation risks pose significant challenges. Ensuring compliance and scientific integrity is essential.

4. Are there regional differences in ivermectin markets post-pandemic?
Yes. Developing countries continue to rely heavily on ivermectin for parasitic diseases, while its use in COVID-19 remains controversial and region-dependent, influenced by local regulations and health policies.

5. Could ivermectin's future lie in combination therapies?
Potentially. Combining ivermectin with other agents could enhance efficacy or broaden indications, but such applications require substantial clinical validation and regulatory approval.

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References
[1] World Health Organization. (2021). Essential Medicines List.
[2] U.S. Food and Drug Administration. (2021). FDA warnings about ivermectin use.
[3] National Institutes of Health. (2022). COVID-19 Treatment Guidelines.