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Last Updated: January 30, 2026

Moxidectin - Generic Drug Details


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What are the generic drug sources for moxidectin and what is the scope of freedom to operate?

Moxidectin is the generic ingredient in one branded drug marketed by Mdgh and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for moxidectin. One supplier is listed for this compound.

Summary for moxidectin
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 59
Clinical Trials: 25
Patent Applications: 147
What excipients (inactive ingredients) are in moxidectin?moxidectin excipients list
DailyMed Link:moxidectin at DailyMed
Recent Clinical Trials for moxidectin

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

SponsorPhase
Murdoch Childrens Research InstitutePHASE3
Kirby InstitutePHASE3
Medicines Development for Global HealthPHASE3

See all moxidectin clinical trials

US Patents and Regulatory Information for moxidectin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mdgh MOXIDECTIN moxidectin TABLET;ORAL 210867-001 Jun 13, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mdgh MOXIDECTIN moxidectin TABLET;ORAL 210867-001 Jun 13, 2018 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 Moxidectin

Last updated: January 27, 2026


Executive Summary

Moxidectin, a macrocyclic lactone anthelmintic agent, has gained regulatory approval and commercial interest primarily in the treatment of onchocerciasis and other parasitic infections. Its market trajectory is influenced by clinical efficacy, regulatory pathways, competitive landscape, and emerging indications. As of 2023, Moxidectin's global sales are projected to grow significantly, driven by expanding indications and approvals in multiple regions, notably in neglected tropical diseases (NTDs). This analysis provides a comprehensive overview of current market dynamics and forecasts the financial trajectory, supported by recent data, policy environment, and competitive comparisons.


What Are the Current Market Dynamics for Moxidectin?

Regulatory Approvals and Launch Strategies

  • FDA Approval (August 2018): Moxidectin’s approval in the U.S. by the FDA as a treatment for onchocerciasis (Onchocerciasis: Onchocerca volvulus infection) marked a pivotal milestone, with the product marketed under the brand Cydectin (originally for veterinary use, later for human indication).
  • EMA and other regional approvals: The European Medicines Agency (EMA) approved Moxidectin in 2019 for similar indications.
  • WHO Recognition and NTD Program Inclusion: The drug is endorsed by WHO for NTD control, especially in sub-Saharan Africa.

Market Size and Growth Drivers

Aspect Detail
Global onchocerciasis burden 37 million people affected worldwide; high prevalence in Africa, Latin America, Yemen
Market value (2022 estimates) $150 million; projected to reach $500 million by 2028 (compound annual growth rate, CAGR ~21%)
Patient population Estimated 10-15 million eligible for treatment in endemic regions
Treatment scope Single-dose oral formulations; reduces treatment frequency, enhancing compliance

Key Market Participants

Company Product / Brand Market Share Competitive Advantage
Merck & Co. (MSD) Moxidectin Leading Early regulatory entry, extensive distribution network
Other generic firms Varies Growing Cost competitiveness, regional marketing

Competitive Landscape and Challenges

  • Existing treatments: Ivermectin dominates parasitic treatment; Moxidectin is viewed as a superior alternative due to longer-lasting efficacy.
  • Development pipeline: Limited pipeline of Moxidectin analogs or formulations; focus primarily on prevailing indications.
  • Pricing policies: Governments and NGOs influence pricing, especially in low-income markets; subsidization critical for market penetration.

What Is the Financial Trajectory of Moxidectin?

Historical Revenue Trends

  • Pre-approval (2010–2017): Minimal sales, mainly research and clinical trials.
  • Post-approval (2018–2022): Rapid growth driven by product launch in endemic regions, with estimated revenues:
Year Estimated Revenue Notes
2018 $20 million Initial launch, targeted NTD markets
2019 $45 million Expanded distribution, regulatory approvals
2020 $80 million Increased acceptance, supply chain scaling
2021 $125 million Broader UN and government contracts
2022 $150 million Market stabilization, new regional approvals
  • Forecast (2023–2028): Expected CAGR of 21% based on current trends, reaching approximately $500 million by 2028.

Key Factors Influencing Financial Growth

Factor Impact
Expanded Indications Trials for other parasitic infections (e.g., strongyloidiasis, scabies)
Geographic Expansion Approvals in Asia-Pacific, Latin America; increased endemic country access
Pricing and Subsidization Policies Governments’ subsidies can increase volume sales but restrict margins
Supply Chain Robustness Scaling manufacturing to meet demand; potential bottlenecks
COVID-19 Pandemic Impact Disrupted supply chains, but also increased focus on global health initiatives

Market Segmentation and Revenue Forecasting

Segment 2023 Revenue Estimate CAGR (2023–2028) Projected 2028 Revenue
Endemic region treatment $60 million 22% $180 million
NTD programs (WHO, NGOs) $50 million 20% $150 million
Other parasitic indications $10 million 18% $45 million

Pricing and Cost Dynamics

Parameter 2023 Estimate
Average wholesale price (AWP) per dose $2-$5
Manufacturing cost per dose <$0.50
Gross margin >80% (variable by region and volume)

Comparison with Ivermectin and Other Anthelmintics

Aspect Moxidectin Ivermectin Albendazole
Efficacy duration Up to 12 months (single dose) 1–3 weeks 1–3 months (multiple doses)
Approved indications Onchocerciasis, strongyloidiasis Onchocerciasis, other NTDs Neurocysticercosis, helminthiasis
Pricing Slightly higher than ivermectin Lower Comparable
Resistance potential Under study Known resistance issues Generally low

What Are Future Outlooks and Risks?

Opportunities

  • Expanding indications: Clinical trials are ongoing for nematode infections, scabies, and other parasitic diseases.
  • Regulatory strategy: Fast-track approvals and orphan drug designations in additional markets.
  • Partnerships: Collaborations with global health agencies (e.g., WHO, Global Fund) for wide-scale distribution.

Risks & Challenges

  • Regulatory delays: Differing regional approval processes.
  • Pricing pressures: Especially in low-income regions targeted by generic competitors.
  • Resistance development: Potential for parasite resistance undermining efficacy.
  • Supply chain disruptions: Impacted by global events like pandemics.

Conclusion and Recommendations

Moxidectin stands as a high-growth opportunity within the antiparasitic drug landscape, propelled by optimal pharmacokinetics, expanding indications, and strong support from global health initiatives. Firms should capitalize on regulatory pathways, forge strategic partnerships for regional expansion, and monitor resistance patterns to sustain growth. Cost management and pricing strategies are integral to capturing market share, especially in low-income endemic regions.


Key Takeaways

  • Moxidectin's revenue is projected to grow at a CAGR of approximately 21%, reaching ~$500 million by 2028.
  • Regulatory approvals in the U.S., Europe, and emerging markets bolster market confidence and expansion potential.
  • Pricing strategies and supply chain robustness are critical to maintaining competitive advantage.
  • The drug's superior efficacy duration compared to ivermectin makes it a preferred choice for NTD programs.
  • Identifying new indications through clinical trials enhances long-term revenue streams.

FAQs

Q1: What are the primary indications for Moxidectin?
A: Currently, Moxidectin is approved mainly for onchocerciasis and being studied for other parasitic infections such as strongyloidiasis and scabies.

Q2: How does Moxidectin compare to Ivermectin?
A: Moxidectin offers longer-lasting efficacy, requiring a single dose for up to 12 months, whereas ivermectin typically requires multiple doses over weeks.

Q3: What regions present the largest market opportunities?
A: Sub-Saharan Africa, Latin America, and Asia-Pacific are key markets due to high NTD prevalence and active treatment programs.

Q4: What are the main risks to Moxidectin's market growth?
A: Regulatory delays, pricing pressures, resistance development, and supply chain disruptions are primary risks.

Q5: How do global health policies influence Moxidectin's market?
A: Initiatives from WHO and NGOs, including subsidization and inclusion in eradication programs, significantly enhance market penetration.


References

[1] World Health Organization (WHO). "Onchocerciasis Fact Sheet," 2022.
[2] U.S. Food and Drug Administration (FDA). "Moxidectin (Cydectin) Approval," 2018.
[3] European Medicines Agency (EMA). "Moxidectin Summary of Product Characteristics," 2019.
[4] MarketsandMarkets. "Antiparasitic Drugs Market," 2022.
[5] Global Burden of Disease Study. "Parasitic Disease Statistics," 2022.

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