Last Updated: August 8, 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: 213
What excipients (inactive ingredients) are in moxidectin?moxidectin excipients list
DailyMed Link:moxidectin at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for moxidectin
Generic Entry Date for moxidectin*:
Constraining patent/regulatory exclusivity:

TREATMENT OF ONCHOCERCIASIS DUE TO ONCHOCERCA VOLVULUS IN PEDIATRIC PATIENTS AGED 4 TO LESS THAN 12 YEARS AND WEIGHING AT LEAST 13 KG

Dosage:

TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for moxidectin

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

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

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Mdgh MOXIDECTIN moxidectin TABLET;ORAL 210867-001 Jun 13, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: July 26, 2026

Moxidectin market dynamics and financial trajectory: pricing, demand drivers, competitive pressure, and revenue outlook

Moxidectin is a veterinary antiparasitic used primarily against endo- and ectoparasites, with product positioning and revenue largely tied to parasite seasonality, resistance management, and ongoing expansion of approved indications across major livestock geographies. Financial trajectory depends on (1) manufacturer share in branded channels, (2) pace of generic and label expansions, and (3) competitive intensity from alternative macrocyclic lactones and newer antiparasitic classes.

Because “MOXIDECTIN” is not a single, FDA/EMA-defined drug brand in the public domain and multiple jurisdictions and formulations exist (notably oral and topical veterinary products), a complete, accurate financial trajectory requires a specific licensed product and geography. Without that, any revenue or exclusivity-linked market forecast would be incomplete.

What drives moxidectin demand in veterinary antiparasitic markets?

Moxidectin demand is determined by parasitology outcomes in target species and by how well dosing regimens fit real farm protocols.

Parasite seasonality and control program cycles

  • Revenue timing typically tracks high parasite pressure periods (warm, humid months in many temperate markets) when farmers intensify treatment schedules.
  • Strategic stocking before peak season can smooth quarterly revenue, but late approvals or supply constraints can create short-term volatility.

Resistance management and switching behavior

  • Macrocyclic lactone resistance risk (especially in nematodes and some ectoparasites) shifts demand between molecules within the same class.
  • Moxidectin adoption increases when it delivers consistent efficacy in rotational programs or as a replacement after reduced performance of older actives.

Species and indication breadth

  • Broader label coverage (additional parasite species, age ranges, and dosing intervals) generally increases addressable market size.
  • Updates that reduce dosing frequency or enable more flexible administration improve compliance and can shift share from competitors.

Pricing power versus channel conditions

  • Veterinary markets often see price compression where multiple generics or competing branded products coexist.
  • The strongest pricing power typically aligns with (a) differentiated efficacy, (b) fewer comparable alternatives on-label, and (c) entrenched distributor relationships.

How does the moxidectin competitive landscape affect pricing and market share?

Moxidectin competes within macrocyclic lactones and against other antiparasitics used in the same farm treatment calendars.

Key competitor categories

  • Other macrocyclic lactones: ivermectin, doramectin, eprinomectin, selamectin, abamectin (depending on species and route).
  • Anthelmintic classes: benzimidazoles, imidazothiazoles, nicotinic acetylcholine receptor agonists, and newer targeted or combination products where available.

Share dynamics and substitution

  • When competitors maintain label breadth and price positioning, moxidectin tends to face margin pressure.
  • Switching to moxidectin usually happens after documented performance issues with alternative products or where a competitor’s label fails to match the farmer’s parasite profile.

Manufacturing and supply stability

  • API and formulation scale can influence short-term availability and distributor allocations during peak seasons.
  • Supply interruptions can accelerate loss of shelf position, especially in retail-facing channels.

When does moxidectin face generic or label-expansion risk?

In veterinary, “exclusivity” is typically governed by data protection, marketing authorization timelines, and regulatory exclusivity regimes rather than the US Hatch-Waxman construct used for human drugs. The generic risk depends on:

  • Whether the original product uses protected manufacturing methods or formulation advantages.
  • The scope of data protection for the approved dossiers in each jurisdiction.
  • Whether competitor filings can rely on bridging to existing reference products.

What to track for exclusivity and entry risk

  • Change in authorization holders for key dossiers or transfer of marketing rights.
  • Launch of authorized generics or AB-rated equivalents (where jurisdictional frameworks allow).
  • Supplemental approvals expanding indications, which can delay erosion of share even after core authorization.

What financial trajectory does moxidectin typically follow after launch and scale-up?

Without a specific moxidectin product (brand, formulation, species, country), only structural patterns can be stated.

Stage model for revenue curves

  1. Launch ramp

    • Revenue growth is driven by initial adoption, distributor stocking, and first-year conversion among early users.
    • Growth can be lumpy due to veterinary seasonality and inventory cycles.
  2. Plateau / share consolidation

    • As approvals and label confidence expand, unit volumes can stabilize.
    • Price competition starts to appear once multiple channels carry comparable options.
  3. Margin compression

    • Generic or competitive branded alternatives tend to compress prices over time.
    • Manufacturers offset with formulation upgrades, package sizes, or additional claims.
  4. Renewed growth via lifecycle extensions

    • New indications, longer intervals, improved routes, or combination products can re-open growth.
    • If resistance trends increase treatment intensity, volume can grow even under stable pricing.

How do formulation route and dosage form shape moxidectin performance and economics?

Moxidectin’s commercial outcomes differ by route because adherence, handling, and perceived efficacy affect farmer behavior.

Oral versus topical economics

  • Oral products can simplify dosing accuracy and reduce labor requirements for some operations.
  • Topical or injectable formats can be selected for herd management workflows, influencing customer preference independent of parasite biology.

Dosing interval and compliance

  • Longer dosing intervals can improve compliance, reduce labor costs, and support premium pricing.
  • Shorter intervals or complex titration increase total farm handling costs and can reduce willingness to pay.

Package size and stocking

  • Larger pack sizes can reduce unit cost and improve uptake where volumes are predictable.
  • Smaller packs can widen access for mixed operations but can carry lower realized pricing.

What is the role of distribution partnerships in moxidectin revenue?

Veterinary antiparasitic revenue is often distribution-led.

  • Master distributor agreements can lock in shelf space ahead of peak season.
  • Private label or contract manufacturing by wholesalers can commoditize pricing in certain markets.
  • Co-marketing with veterinary practices can lift conversion, especially for newly approved indications.

How does regulatory status by region affect moxidectin sales trajectories?

Sales expand when regulatory clearances align with distributor readiness and farmer demand windows.

Common regional impact mechanisms

  • Approval timing can miss a peak season, shifting revenue into the next cycle.
  • Differences in label restrictions by species or weight bands limit addressable volume.
  • Post-authorization changes in labeling (contraindications, withdrawal periods, or safety updates) can restrict demand temporarily.

Which manufacturers commercialize moxidectin and how does that map to financial exposure?

This section cannot be completed accurately without tying “moxidectin” to specific authorized products, holders, and geographies. Market exposure differs substantially by whether the firm sells a leading branded product, a smaller localized product, or a generic portfolio.

What patent estate issues matter for moxidectin commercialization economics?

For moxidectin, patent relevance is typically product-dossier and formulation-specific (especially in jurisdictions with data protection regimes) and can affect:

  • Timing of generic authorizations.
  • Use of specific manufacturing methods or stabilized formulations.
  • Label-protected combinations.

A complete patent estate analysis requires a defined product claim set and jurisdictional filing records. Without that, any listing of “patents protecting moxidectin” would risk being inaccurate.

How strong is moxidectin’s revenue resilience under price pressure and resistance trends?

Moxidectin revenue resilience is strongest when:

  • On-label efficacy against the dominant local parasite species remains high.
  • The dosing interval matches farm operational schedules.
  • The product has fewer direct substitutes with equivalent label breadth.
  • Farmers can justify switching based on measured performance outcomes rather than purely on price.

Weakness appears when:

  • Resistance reduces efficacy, driving rapid substitution to other classes or stronger actives.
  • Multiple branded or authorized generic options compress realized pricing.
  • Label expansions lag behind competitor claims in target parasite coverage.

Key competitive and financial scenarios for moxidectin over the next 3 to 5 years

This scenario set is structured to support commercial planning, not to claim specific revenue numbers.

Scenario A: steady share, modest price erosion

  • Happens when resistance management keeps moxidectin relevant but competition increases.
  • Expected outcome: stable unit volumes with declining net pricing; profit depends on cost-down and pack mix.

Scenario B: share gains from label and performance

  • Triggered by new approvals (additional species or parasite targets) or superior dosing convenience.
  • Expected outcome: volume growth offsets partial price erosion; distributor expansion accelerates during peak cycles.

Scenario C: efficacy-driven substitution

  • Triggered by clear local resistance or reduced performance in practice.
  • Expected outcome: unit volume declines; pricing may fall faster as channel partners switch inventory.

Scenario D: accelerated commoditization

  • Triggered by authorized generics in major markets or multi-source competition.
  • Expected outcome: margin compression; market becomes portfolio-managed via economies of scale and lifecycle extensions.

Key Takeaways

  • Moxidectin’s commercial performance is dominated by veterinary parasite pressure cycles, resistance-driven switching, and label breadth by species and geography.
  • Competitive intensity in macrocyclic lactones typically drives price erosion unless moxidectin has differentiated on-label efficacy, dosing convenience, or combination positioning.
  • A precise financial trajectory requires mapping “moxidectin” to specific authorized brands/formulations, country approvals, and distributor channel economics; without that, revenue forecasting would be incomplete.

FAQs

  1. What parasite species most influence moxidectin sales in cattle versus sheep?
  2. How do resistance patterns to macrocyclic lactones change farmer willingness to pay for moxidectin?
  3. Which moxidectin dosage forms (oral, topical, injectable) typically win on compliance and total cost to treat?
  4. How does veterinary regulatory timing (approval dates and label restrictions) shift annual moxidectin revenue cycles?
  5. What mix of pricing, pack size, and distributor contracts most determines moxidectin net revenue in competitive markets?

References

  1. (No sources provided in the prompt.)

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