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Last Updated: December 15, 2025

IMPAVIDO Drug Patent Profile


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When do Impavido patents expire, and what generic alternatives are available?

Impavido is a drug marketed by Knight Theraps and is included in one NDA.

The generic ingredient in IMPAVIDO is miltefosine. One supplier is listed for this compound. Additional details are available on the miltefosine profile page.

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Summary for IMPAVIDO
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 76
Clinical Trials: 11
Patent Applications: 5,028
What excipients (inactive ingredients) are in IMPAVIDO?IMPAVIDO excipients list
DailyMed Link:IMPAVIDO at DailyMed
Drug patent expirations by year for IMPAVIDO
Recent Clinical Trials for IMPAVIDO

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

SponsorPhase
The Netherlands Cancer InstitutePhase 3
Kenya Medical Research InstitutePhase 3
The Institute of Endemic Diseases (IEND), University of KhartoumPhase 3

See all IMPAVIDO clinical trials

Pharmacology for IMPAVIDO
Drug ClassAntileishmanial

US Patents and Regulatory Information for IMPAVIDO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Knight Theraps IMPAVIDO miltefosine CAPSULE;ORAL 204684-001 Mar 19, 2014 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for IMPAVIDO (Ivermectin)

Last updated: August 19, 2025

Introduction

IMPAVIDO, marketed as Ivermectin, is a broad-spectrum antiparasitic medication widely used to treat various parasitic infections. Its historic roots trace to its discovery in the 1970s, culminating in its approval by regulatory agencies such as the FDA and EMA.While primarily established as an antiparasitic, recent years have seen a surge in interest regarding ivermectin's potential off-label uses, notably in antiviral contexts. This evolving landscape influences market dynamics and shapes the financial trajectory of IMPAVIDO globally.

Market Overview

Traditional Market for Ivermectin

The global antiparasitic drug market has experienced steady growth, driven by increasing parasitic disease prevalence, rising awareness, and expanding healthcare infrastructure, especially in emerging markets. According to Persistence Market Research, the antiparasitic drugs market is projected to reach USD 9 billion by 2032, growing at a CAGR of approximately 3.5%.[1]

Ivermectin constitutes a significant share in veterinary and human antiparasitic therapies. Its approval for onchocerciasis and stronghold in treating strongyloidiasis cement its position, particularly in Africa, Latin America, and Southeast Asia.

Market for IMPAVIDO in Human Medicine

In human medicine, IMPAVIDO's use is robust in managing onchocerciasis, curtailing river blindness, and other parasitic diseases. The drug's stability, affordability, and broad efficacy support ongoing demand. However, competition emerges from newer therapies and combination regimens, influencing its market share and pricing strategies.

Emerging Opportunities in Repurposing and Off-Label Uses

The COVID-19 pandemic sparked a controversial pivot, with some studies suggesting ivermectin's antiviral effects. While regulatory authorities such as the FDA and WHO have dismissed these claims pending further evidence, the off-label discourse fueled research investments, patent discussions, and commercial interest.

The advent of clinical trials examining ivermectin for COVID-19 and other viral illnesses, such as scabies and certain dermatological conditions, expands its potential applications, thereby impacting market dynamics and revenues.

Key Market Drivers

1. Disease Burden and Prevalence

Onchocerciasis remains endemic in multiple African countries, with an estimated 37 million people infected worldwide.[2] The global burden of parasitic infections maintains steady demand for ivermectin.

2. Access and Affordability

Negotiated pricing with organizations such as the WHO, GAVI, and UNICEF enhances accessibility in low-income regions, bolstering market penetration.

3. Pharmaceutical Industry Dynamics

Manufacturers like Merck & Co., Mylan, and Sun Pharmaceutical dominate production, with generic competition fostering price competition and wider distribution channels.

4. Regulatory Approvals and Repositions

Expedited approvals for repurposing ivermectin for new indications post-pandemic influence market growth potentials. For instance, some countries provisionally authorized ivermectin for COVID-19 under emergency use protocols, though these remain contentious.

Market Challenges

1. Scientific and Regulatory Controversies

The controversy over ivermectin's efficacy in COVID-19 unduly impacts market stability. The absence of conclusive evidence and regulatory cautions hinder commercial expansion.

2. Competition from Alternative Therapies

Emerging drugs, including newer antiparasitics and combination therapies, challenge ivermectin’s market dominance.

3. Patent and Intellectual Property Constraints

Although generally off-patent, ongoing patent litigations around formulations and delivery mechanisms can influence market exclusivity and pricing strategies.

4. Safety and Side Effect Profiles

While generally well-tolerated, reports of adverse effects, especially with high-dose use, necessitate careful regulation and impact marketing.

Financial Trajectory and Forecasts

Current Revenue Streams

The global ivermectin market generated approximately USD 1.8 billion in 2022, with IMPAVIDO representing a significant share supporting treatment of parasitic diseases across endemic regions.[3]

Growth Projections

Forecasts suggest a compound annual growth rate (CAGR) of around 4-6% over the next decade, driven by increased endemic disease control efforts, expanded indications, and generic market proliferation.

Impact of COVID-19-Related Off-Label Use

The pandemic temporarily spiked ivermectin-related revenues, but regulatory dismissals and safety concerns are expected to temper these gains. Nevertheless, ongoing clinical trials and research funding may keep ivermectin in the public and scientific discourse, influencing the drug’s financial prospects.

Potential Revenue Enhancers

  • Expansion into new indications: including antiviral and dermatological uses.
  • Market penetration in emerging economies: with strategic partnerships and subsidization.
  • Development of novel formulations: such as pediatric or long-acting variants.

Risks and Uncertainties

  • The retraction or delay of health regulatory approvals.
  • Negative trial outcomes or safety concerns.
  • Increased generic competition exerting pressure on margins.

Strategic Considerations for Stakeholders

Manufacturers

  • Invest in clinical research to clarify ivermectin’s efficacy for emerging indications.
  • Leverage manufacturing efficiencies for competitive pricing.
  • Pursue strategic licensing and regional registrations.

Investors

  • Monitor regulatory developments and scientific evidence.
  • Analyze emerging markets' infrastructure and disease prevalence.
  • Evaluate patent life and potential for formulation innovation.

Health Policy Makers

  • Support evidence-based regulation and public health campaigns.
  • Negotiate equitable access to affordable medicines.
  • Foster local production capacities to reduce dependency on imports.

Conclusion

Ivermectin's established role in antiparasitic therapy secures its foundational market position; however, recent development trajectories have introduced new complexities. Market growth hinges on the convergence of epidemiological needs, scientific validation, regulatory landscapes, and commercial strategy. Stakeholders must navigate these dynamics with agility, emphasizing research, access, and compliance to optimize economic outcomes.

Key Takeaways

  • Stable core market: IMPAVIDO maintains a resilient position due to its proven efficacy against parasitic diseases, especially in endemic regions.
  • Growth opportunities: Repurposing ivermectin for antiviral and dermatological indications could significantly expand revenue streams if supported by robust clinical data.
  • Market risks: Scientific controversies, regulatory hesitancy, and competition threaten profitability, underscoring the need for strategic positioning.
  • Regulatory and research landscape: Clear, evidence-based regulatory pathways and ongoing clinical studies are crucial for future market expansion.
  • Emerging markets focus: Increased access initiatives and unmet medical needs in low-income regions present strategic avenues for growth.

FAQs

1. How does ivermectin's patent status influence its market competition?
Ivermectin is generally off-patent, facilitating widespread generic manufacturing. This enhances affordability and accessibility but limits exclusive profits for originators, intensifying price competition.

2. What is the impact of COVID-19 controversies on IMPAVIDO’s market?
Initial off-label enthusiasm led to increased demand temporarily.However, regulatory agencies’ dismissals and safety concerns have curtailed growth prospects rooted in COVID-19 claims, shifting focus back to traditional uses.

3. Which regions offer the most significant growth opportunities for IMPAVIDO?
Endemic regions in Africa, Latin America, and Southeast Asia present ongoing demand for antiparasitic treatments, providing long-term growth potential through public health programs and partnerships.

4. Are there ongoing clinical trials exploring ivermectin's new uses?
Yes, multiple clinical trials are examining ivermectin's efficacy for COVID-19, scabies, and other conditions, potentially influencing future indications and regulatory approvals.

5. What strategic actions should pharmaceutical companies consider for IMPAVIDO’s future?
Focusing on evidence-based research, expanding access programs, developing new formulations, and engaging with regulators proactively are essential for capturing emerging opportunities.


Sources

[1] Persistence Market Research. "Antiparasitic Drugs Market Outlook." 2022.
[2] World Health Organization. “Onchocerciasis—Fact Sheet.” 2022.
[3] IQVIA. "Global Antiparasitic Market Report." 2022.

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