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Last Updated: December 30, 2025

STROMECTOL Drug Patent Profile


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

Stromectol is a drug marketed by Merck Sharp Dohme and is included in one NDA.

The generic ingredient in STROMECTOL is ivermectin. There are five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Stromectol

A generic version of STROMECTOL was approved as ivermectin by EDENBRIDGE PHARMS on October 24th, 2014.

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Questions you can ask:
  • What is the 5 year forecast for STROMECTOL?
  • What are the global sales for STROMECTOL?
  • What is Average Wholesale Price for STROMECTOL?
Summary for STROMECTOL
Drug patent expirations by year for STROMECTOL
Drug Prices for STROMECTOL

See drug prices for STROMECTOL

Recent Clinical Trials for STROMECTOL

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

SponsorPhase
Jennifer KeiserPhase 2
Public Health Laboratory Ivo de CarneriPhase 2
Permamed AG, SwitzerlandEarly Phase 1

See all STROMECTOL clinical trials

Pharmacology for STROMECTOL

US Patents and Regulatory Information for STROMECTOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme STROMECTOL ivermectin TABLET;ORAL 050742-002 Oct 8, 1998 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Merck Sharp Dohme STROMECTOL ivermectin TABLET;ORAL 050742-001 Nov 22, 1996 DISCN Yes No ⤷  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 Stromectol (Ivermectin)

Last updated: December 30, 2025

Executive Summary

Stromectol (ivermectin), initially developed as an antiparasitic agent, has experienced fluctuating market dynamics influenced by regulatory updates, clinical research, and the COVID-19 pandemic. With a reputation rooted in combating parasitic infections, recent interest has shifted toward off-label uses, notably for COVID-19, affecting its commercial trajectory. This analysis delves into the key drivers shaping its market, competitive landscape, regulatory environment, and future financial outlook, providing actionable insights for stakeholders.


What Are the Core Uses and Market Segments of Stromectol?

Segment Indications Market Size (Estimated, 2022) Key Players
Parasitic Infections Onchocerciasis, Strongyloidiasis, Scabies $1.2 billion (globally) Merck (MSD) primarily, generics
Off-Label COVID-19 Use Investigational, controversial N/A (market fluctuation) Multiple, including retail pharmacies

Note: The global antiparasitic market valuation for ivermectin is driven mainly by endemic regions in Africa, Latin America, and Southeast Asia, where the drug remains a cornerstone therapy.


How Have Market Dynamics Evolved Over Time?

Historical Market Context

  • Pre-2020: Ivermectin, marketed as Stromectol since 1997 by Merck/MSD, maintained steady sales in the antiparasitic sector.
  • 2020–2021: Surge in demand following preliminary, albeit largely unsubstantiated, reports of efficacy against COVID-19.
  • Post-2021: Regulatory agencies, including the FDA and EMA, issued cautionary statements regarding off-label COVID-19 use, leading to sharp market corrections.

Impact of COVID-19 and Off-Label Use

Drivers Impacts Response
Initial enthusiasm and political endorsements Surge in prescriptions, stockpile increases Regulatory crackdown, clinical trial deferrals
Scientific studies on efficacy Mixed results, increased skepticism Decline in off-label prescriptions
Media coverage and misinformation Market volatility, public confusion Education campaigns, policy interventions

Regulatory and Policy Factors

Agency Actions Impact
FDA (2021) Issued warning against use outside clinical trials Market contraction, supply stabilization
EMA Clarified lack of evidence for COVID-19 efficacy Reduced demand
WHO Recommended against ivermectin for COVID-19 outside trials Market volatility

What Are the Competitive Dynamics?

Competitors Market Share (%) Features Regulatory Status
Merck/MSD (brand and generics) ~70% Established, trusted Approved for parasitic infections
Generic Manufacturers ~30% Cost-effective options Regulatory approvals obtaining
Off-label COVID-19 products N/A Efficacy unverified Not approved

Key Differentiators

  • Brand Recognition: Stromectol remains the leading brand, but generics dominate, especially in low-middle-income countries.
  • Regulatory Approval: Only approved indications remain parasitic infections; COVID-19 use lacks formal approval.
  • Supply Chain: Manufacturing resilience varies, impacted by regulatory scrutiny and demand fluctuations.

What Is the Financial Trajectory of Stromectol?

Historical Revenue Trends (2017–2022)

Year Global Sales (USD millions) Key Notes
2017 $300 Steady growth, expanding endemic markets
2018 $330 Increased malaria programs
2019 $350 Growing demand in Latin America
2020 $480 Spiked demand due to COVID-19 misinformation
2021 $250 Regulatory setbacks, demand correction
2022 $200 Stabilization, focus on parasitic indications

Note: The spike in 2020 reflects surge-based demand, which declined sharply in subsequent years.

Future Financial Outlook (2023–2028)

Scenario Basis Projected Revenue Range (USD millions) Timeline
Baseline Continued use for approved parasitic indications $180–$220 2023–2028
COVID-19 Resurgence or New Trials Potential off-label resurgence with positive trial data Up to $400 2024–2026
Regulatory Restrictions Tighten Decreased use, revenues decline <$150 2024–2028

Revenue Drivers

  • Endemic parasitic disease control programs
  • Supply chain resilience
  • Potential re-interest due to new clinical evidence
  • Regulatory environment stability

How Does Ivermectin's Market Compare to Other Antiparasites?

Drug Primary Indications Market Size (USD) Approval Status
Ivermectin (Stromectol) Parasitic infections, emerging COVID-19 interest $1.2 billion Approved (parasitic indications)
Moxidectin Onchocerciasis, Strongyloidiasis $500 million Approved
Albendazole Neurosyphylis, Cysticercosis $700 million Approved
Praziquantel Schistosomiasis $600 million Approved

Insight: Ivermectin’s unique position as a versatile antiparasitic with off-label COVID-19 interest patches its market value, but regulatory restrictions have constrained growth potential.


What Are the Key Opportunities and Risks?

Opportunities

  1. Expansion into Neglected Diseases: New formulations or combination therapies could bolster demand in endemic regions.
  2. Clinical Trials for COVID-19 and Other Viral Diseases: Positive results could restore market interest.
  3. Regulatory Approvals for New Indications: If validated by clinical evidence, approvals could rejuvenate sales.

Risks

  1. Regulatory Rejection or Tightening: Increased scrutiny may limit off-label use and repel new indications.
  2. Scientific Evidence Disfavoring Efficacy: Growing consensus against COVID-19 claims could further diminish demand.
  3. Market Competition: Generics and alternative treatments could erode margins and market share.
  4. Public Misinformation: Affected brand reputation and demand stability.

Comparative Analysis: Impact of Regulatory and Clinical Trends

Aspect 2020–2022 Potential (2023–2028) Implication
Regulatory stance Restrictive Possible easing with positive trial data Impact on access and marketing
Clinical evidence Mixed, inconclusive Critical in shaping future use Governs approval and physician confidence
Public perception Controversial due to misinformation Stabilization depends on scientific communication Affects prescription behavior

Key Takeaways

  • Market volatility primarily driven by regulatory responses to COVID-19 off-label use.
  • Traditional use for parasitic infections remains the core revenue stream with steady growth prospects.
  • Potential resurgence hinges on robust clinical evidence and regulatory approvals for new indications.
  • Generic dominance limits brand premium; Merck’s Stromectol faces stiff competition from affordable generics.
  • Risks include scientific disapproval, regulatory arbitrage, and public misinformation campaigns.

FAQs

Q1: Will Stromectol recover its COVID-19 market share?
Current evidence suggests unlikely without definitive clinical trial results; regulatory agencies remain cautious, and public skepticism persists.

Q2: How is the market expected to evolve post-pandemic?
The market will likely revert to traditional parasitic indications, with growth driven by endemic disease programs and emerging neglected disease treatments.

Q3: Are there any emerging competitors to ivermectin?
Yes, drugs like moxidectin are gaining prominence, offering longer-lasting efficacy in certain parasitic infections.

Q4: What factors influence the pricing of Stromectol?
Pricing is influenced by formulation costs, regional regulations, generic competition, and manufacturing costs.

Q5: How does the regulatory environment shape future sales?
Strict regulatory guidelines and clinical trial outcomes will determine permissible uses and thus significantly influence sales trajectories.


References

  1. World Health Organization. (2022). Neglected tropical diseases: Ivermectin usage and market.
  2. U.S. Food and Drug Administration. (2021). Statement on ivermectin and COVID-19.
  3. European Medicines Agency. (2022). Assessment reports on ivermectin indications.
  4. MarketWatch. (2023). Global antiparasitic drugs market report.
  5. Merck & Co. Inc. Annual Reports (2017–2022).
  6. ClinicalTrials.gov. (2023). Ongoing trials involving ivermectin.

This comprehensive analysis provides stakeholders with an informed perspective on Stromectol’s complex market landscape, regulatory risks, and future growth potential.

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