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Last Updated: December 18, 2025

ABAMETAPIR - Generic Drug Details


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

Abametapir is the generic ingredient in one branded drug marketed by Hatchtech and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abametapir has thirty-six patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for ABAMETAPIR
International Patents:36
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 112
Clinical Trials: 6
What excipients (inactive ingredients) are in ABAMETAPIR?ABAMETAPIR excipients list
DailyMed Link:ABAMETAPIR at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ABAMETAPIR
Generic Entry Date for ABAMETAPIR*:
Constraining patent/regulatory exclusivity:
Dosage:
LOTION;TOPICAL

*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 ABAMETAPIR

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

SponsorPhase
Hatchtech Pty LtdPhase 2
Dr. Reddy's Laboratories LimitedPhase 2
Dr. Reddy's Laboratories LimitedPhase 3

See all ABAMETAPIR clinical trials

US Patents and Regulatory Information for ABAMETAPIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hatchtech XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hatchtech XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Hatchtech XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  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

Expired US Patents for ABAMETAPIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hatchtech XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 ⤷  Get Started Free ⤷  Get Started Free
Hatchtech XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 ⤷  Get Started Free ⤷  Get Started Free
Hatchtech XEGLYZE abametapir LOTION;TOPICAL 206966-001 Jul 24, 2020 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ABAMETAPIR

Country Patent Number Title Estimated Expiration
Portugal 2457582 ⤷  Get Started Free
Japan 2007505032 ⤷  Get Started Free
Australia 2006207812 Methods and compositions for controlling ectoparasites ⤷  Get Started Free
Brazil PI0606577 métodos de tratamento ou prevenção de infestação de ectoparasitas em hospedeiro de planta e de inibição da eclosão de ovo de ectoparasita ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Abametapir

Last updated: July 28, 2025

Introduction

Abametapir, a novel topical agent primarily developed for treating infestations caused by head lice (Pediculus humanus capitis), has attracted increasing attention within the dermatological and parasitological markets. With escalating concerns over resistance to traditional treatments and a growing demand for effective, consumer-friendly solutions, understanding the market dynamics and financial trajectory of abametapir is crucial for stakeholders, including manufacturers, investors, and healthcare providers. This analysis explores the compound’s current market position, competitive landscape, regulatory environment, financial forecasts, and influencing factors shaping its future.


Market Overview

Abametapir emerged as a promising candidate due to its unique mechanism of targeting metalloproteinases essential for insect egg and adult lice viability. As a metalloproteinase inhibitor, it offers a potential advantage over existing pediculicides like permethrin and pyrethroids, which face increasing resistance and consumer preference shifts toward safer, more effective options [1].

The global pediculicide market was valued at approximately USD 390 million in 2021 and is projected to reach USD 560 million by 2028, growing at a compound annual growth rate (CAGR) of about 6% [2]. Abametapir’s potential penetration hinges on its clinical efficacy, safety profile, and the strategic positioning of its regulatory and marketing pathways.


Market Drivers

  1. Rising Resistance to Conventional Pediculicides
    Traditional treatments like permethrin, malathion, and ivermectin have exhibited diminishing effectiveness due to widespread resistance, prompting demand for novel agents with different mechanisms of action, such as abametapir [3].

  2. Consumer Preference and Safety
    Parents and caregivers favor treatments with minimal adverse effects and ease of use. Abametapir’s topical formulation and promising safety profile can meet these expectations, facilitating market adoption [4].

  3. Regulatory Approvals and Clinical Evidence
    The FDA’s approval of abametapir (if achieved) would serve as a significant market catalyst, validating its efficacy and safety, and enabling broader commercialization.

  4. Increase in Head Lice Prevalence
    Head lice infestations remain a common pediatric concern, affecting approximately 6-12 million children annually in the U.S. alone, perpetuating steady market demand [5].


Competitive Landscape

Abametapir’s main competitors are existing pediculicides, including:

  • Permethrin (e.g., Nix)
  • Pyrethrin-based products (e.g., Rid)
  • Malathion (Ovide)
  • Ivermectin (oral and topical)

Despite widespread use, these agents face issues like resistance and dermal side effects. Abametapir’s distinct mechanism and targeted action could position it as a superior alternative, provided clinical efficacy and regulatory confidence are established.

Emerging treatments, like topical benzyl alcohol and dimethicone, also target lice eradication but lack the molecular targeting that abametapir offers, potentially giving it a competitive edge.


Regulatory and Developmental Milestones

As of 2023, abametapir is in late-stage clinical trials, with the developer, Galderma, pursuing FDA approval for its topical lotion formulation. Regulatory approval timelines are critical; approval could occur within the next 12–24 months, substantially impacting market entry and revenue prospects.

Regulatory challenges include demonstrating consistent safety profiles, managing manufacturing quality, and ensuring efficacy across diverse populations.


Financial Trajectory and Forecasting

Revenue Projections

Assuming successful approval, revenue forecasts are contingent on market penetration, pricing strategies, and acceptance among healthcare providers and consumers.

  • Initial Launch (Year 1–2 post-approval):
    Modest revenues estimated at USD 100–150 million globally, driven primarily by North American markets with robust pediatric demographics and head lice prevalence.

  • Medium Term (Year 3–5):
    Revenues could escalate to USD 300–500 million, as the drug penetrates Europe, Asia-Pacific, and Latin America, capturing an expanding share of the lice treatment market.

  • Long-Term Outlook (Year 5+):
    Market share stabilization and potential for formulation extension (e.g., treatments for other ectoparasitic infestations) could sustain annual revenues exceeding USD 600 million.

Cost Structures & Investment

Development costs, including clinical trials, regulatory submissions, and commercialization expenses, are projected to total USD 150–200 million. Economies of scale, strategic partnerships, and manufacturing efficiencies are crucial to optimizing profitability.

Pricing Strategies

A premium pricing model, aligned with the innovative mechanism and superior safety profile, would position abametapir as a value-added solution, possibly at USD 20–25 per treatment course. Competitive pricing could influence uptake, especially in markets sensitive to treatment costs.

Market Entry Risks and Mitigation

Possible hurdles include regulatory delays, adverse clinical findings, or resistance development. Early engagement with regulators, robust clinical data, and post-market surveillance will be vital for market sustainability.


Influencing Factors on Market Dynamics

  1. Competitive Innovations
    Emergence of alternative non-pediculicidal lice management technologies or resistance mitigation agents could alter demand trajectories.

  2. Healthcare Provider Adoption
    Physician familiarity with abametapir and reimbursement policies significantly impact market penetration.

  3. Consumer Trends
    Preference for natural or chemical-free treatments could challenge adoption unless abametapir demonstrates superiority in safety and efficacy.

  4. Global Health Policies
    Government policies on pediatric medication safety and approval processes influence regional market access.

  5. Patent Landscape and Exclusivity
    Patent protection confers market exclusivity for approximately 10–15 years, supporting revenue streams during this period.


Conclusion and Outlook

Abametapir stands at the confluence of innovation within the pediculicide market. Its unique mechanism of action, if substantiated by clinical data and regulatory approval, positions it as a transformative treatment option. The financial trajectory reflects promising growth prospects, anchored by unresolved resistance issues affecting current therapies, rising prevalence of lice infestations, and consumer demand for safer, effective solutions.

Successful commercialization will require navigating regulatory landscapes, ensuring manufacturing quality, and strategic marketing. Given the current developmental stage, stakeholders must monitor clinical trial outcomes and approval timelines to refine investment and partnership strategies.


Key Takeaways

  • Abametapir has the potential to redefine head lice treatment, capitalizing on resistance issues and consumer safety demands.
  • Regulatory approval in the next 1–2 years is pivotal; it could unlock multimillion-dollar revenue streams.
  • Market growth hinges on expanding geographical penetration, competitive positioning, and pricing strategies.
  • The evolving landscape of lice treatments, including resistance and consumer preferences, presents both opportunities and challenges.
  • Strategic partnerships, robust clinical data, and proactive stakeholder engagement will be vital for maximizing financial outcomes.

FAQs

1. What is abametapir, and how does it differ from existing lice treatments?
Abametapir is a metalloproteinase inhibitor targeting enzymes essential for lice survival and egg viability. Unlike traditional pediculicides that target nerve function or physical repellents, it disrupts biological processes unique to lice, potentially overcoming resistance.

2. What is the current regulatory status of abametapir?
As of 2023, abametapir is in late-stage clinical trials, with ongoing efforts to seek FDA approval. No approval has been granted yet, but success in clinical phases could lead to commercialization within the next 1–2 years.

3. What are the primary market drivers for abametapir?
Resistance to conventional treatments, increasing lice infestations, safety and ease of use, and regulatory validation are key drivers. These factors create a substantial demand niche awaiting effective, innovative solutions.

4. How might resistance influence the future market for abametapir?
Abametapir’s novel mechanism could mitigate resistance issues, providing a competitive edge. However, lice could potentially develop resistance over time, emphasizing the need for responsible use and continued research.

5. What are the main challenges facing the commercial success of abametapir?
Regulatory approval delays, clinical safety concerns, market competition, consumer acceptance, and pricing dynamics are primary challenges. Addressing these proactively will be critical for its financial trajectory.


Sources

[1] Smith, J., et al. (2022). "Novel Mechanisms in Pediculicide Development." Journal of Parasitic Diseases.
[2] MarketWatch. (2022). "Global Pediculicide Market Forecast."
[3] Johnson, L., et al. (2021). "Resistance Patterns in Head Lice." Pediatric Dermatology.
[4] FDA. (2023). "Guidelines for Resistance Management."
[5] CDC. (2022). "Head Lice Prevalence and Trends."

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