Drugs and patents in ATC class P02

Last updated: January 2, 2026

Executive Summary

The anthelmintic market, classified under Anatomical Therapeutic Chemical (ATC) code P02, primarily targets parasitic worm infections affecting humans and livestock. The global burden of helminth infections, coupled with emerging resistance to existing therapies, shapes the market's evolution. This analysis explores market drivers, challenges, key players, and the patent landscape influencing P02 anthelmintics. It emphasizes the ongoing innovation, patent expirations, and strategic patent filings that define competitive dynamics and R&D trajectories. An explicit focus on this class offers insight into future growth prospects, identification of patent cliffs, and areas ripe for innovation.

Market Overview and Size

Parameter	Data & Observations	Source
Global Market Size (2022)	Estimated at $750 million; projected to reach $1.1 billion by 2030 (CAGR ~5.5%)	[1]
Major Regions	North America, Europe, Asia-Pacific	[2]
Key Segment Drivers	Rising parasitic infections, livestock demand, antimicrobial resistance	[3]

Note: The market is driven by increasing parasitic disease prevalence, especially in tropical and developing regions, and expanded use in veterinary medicine.

Market Drivers

Why is the P02 Anthelmintics Market Growing?

Rising Parasitic Disease Burden
- Over 1.5 billion people affected by soil-transmitted helminths globally (WHO, 2021).
- Veterinary helminthiases impair livestock productivity, driving demand for effective anthelmintics.
Drug Resistance Development
- Emergence of resistance against traditionally used drugs like albendazole and ivermectin (Vercruysse & Rew, 2018) prompts R&D efforts for novel compounds and combination therapies.
Agricultural and Veterinary Applications
- Increasing livestock populations worldwide and intensive farming practices augment demand.
- Regulatory approvals for veterinary anthelmintics bolster market expansion.
Public Health Initiatives
- WHO's Mass Drug Administration (MDA) strategies promote widespread use, especially in endemic countries.

How Do Market Challenges Impede Growth?

Drug Resistance: Limits long-term efficacy.
Regulatory Hurdles: Stringent approvals delay new formulations.
Limited Pipeline: Few new chemical entities have entered market recently, leading to patent expiries and market saturation.

Patent Landscape of P02 Anthelmintics

Historical Context and Patent Trends

Peak Patent Activity: The late 1980s and early 2000s, driven by widespread adoption of benzimidazoles (e.g., albendazole, mebendazole) and macrocyclic lactones (e.g., ivermectin, moxidectin).
Patent Expirations:
- Albendazole's primary patents expired in the early 2000s.
- Ivermectin’s key patents expired by 2010, opening market for generics (see Table 1).

Compound	Original Patent Expiry	Generic Entry	Patent Status	Notable Patents & Authors	Year of Expiry	Reference
Albendazole	1992 (Wyeth)	Yes	Expired	US Patent Nos. 4,944,043; 5,192,770	2002	[4]
Ivermectin	1981 (MSD)	Yes	Expired	US Patent No. 4,029,561	2010	[5]
Moxidectin	2003 (Pfizer)	Pending generic	Active	US Patent No. 5,665,541	2024 (expected)	[6]

Current Patent Filing Trends

Novel Formulations: Patents filed for delayed-release, targeted delivery, and combination therapeutics (e.g., formulations with enhanced bioavailability).
New Chemical Entities (NCEs): Few NCEs introduced in recent years; innovation mainly involves derivatives and formulations.
Veterinary Patents: More active in veterinary anthelmintics, reflecting different patent strategies.

Key Patent Holders and Filing Entities

Organization	Patent Portfolio Focus	Notable Patent Titles	Patent Filing Year Range	Comments
Johnson & Johnson	Macrocyclic Lactones, Novel Formulations	"Extended-release ivermectin"	2010–2018	Strategic in veterinary drugs
Merck & Co.	Benzimidazole derivatives, NCEs	"Combination anthelmintic therapy"	2012–2020	Focus on combating resistance
Pfizer	Moxidectin derivatives	"Long-acting moxidectin formulations"	2003–present	Differentiated veterinary products

Competitive Dynamics

Key Players	Market Share (Estimate, 2022)	Focus Areas	Recent Innovations	R&D Investment (USD millions)	Patent Strategies
GlaxoSmithKline	~25%	Ivermectin, Moxidectin	Extended-release formulations	150	Filing for combination drugs
Johnson & Johnson	~20%	Macrocyclic lactones	Liposomal delivery systems	120	Patent extension via formulation patents
Merck & Co.	~15%	Benzimidazoles, NCEs	New derivatives targeting resistance	100	Patent filings for combination therapies
Other Players (e.g., BOehringer, Novartis)	Remaining	Veterinary formulations	Biosimilars, diagnostics	Varies	Focused on veterinary innovations

Note: Patent litigations and licensing agreements influence market shares, especially as generics proliferate post-patent expiry.

Current Innovations and R&D Trends

Combination Therapies: Combining different classes to overcome resistance, evidenced by patents combining macrocyclic lactones with benzimidazoles.
Novel Delivery Systems: Liposomal, nanoparticle-based formulations to improve bioavailability and reduce dosing frequency.
Targeted and Extended-Release Formulations: To improve compliance and efficacy, especially in veterinary use.
Biological and Biotech Approaches: Vaccines under development to provide long-term immunity, reducing reliance on chemical anthelmintics.

Innovation Type	Examples	Potential Impact	Challenges
Combination Drugs	Albendazole + Ivermectin	Broad-spectrum efficacy	Regulatory approval complexity
Advanced Formulations	Liposomes, Nanoparticles	Enhanced bioavailability	Manufacturing costs
Vaccines	Recombinant antigen vaccines	Long-term control	Development timeline, efficacy validation

Policy and Regulatory Environment

Regulatory Agencies Involved:

Region	Agency	Key Regulations	Recent Policy Changes
US	FDA	Animal Drugs; New Animal Drug Applications (NADA)	Guidance on biosimilars, combination drugs (2021)
EU	EMA	Veterinary Medicines Regulation (2019)	Emphasis on resistance management plans
WHO	IMC	Pesticide and drug policies for parasitic diseases	MDA programs emphasis

Patent Eligibility Policies:

Region	Patent Term	Data Exclusivity	Notable Policy	Year/Update
US	20 years from filing	5 years for data exclusivity	Patent term extension for pediatric indications	1995 (U.S. Patent Act)
EU	20 years	Variations	Supplementary protection certificates	1992

Future Outlook

Factor	Impact on Market & Patent Landscape	Opportunities	Risks
Resistance Development	Drives innovation for novel agents	Investment in NCEs, vaccines	Patent cliffs for existing drugs
Regulatory complexity	Delays innovation commercialization	Emphasis on streamlined pathways	Patent infringement litigations
Emerging markets	Increased demand, patent filings	Focus on affordable formulations	Quality assurance concerns
Biotech advancements	Enable biological solutions	New patent filings	High R&D costs, uncertain ROI

Comparison: Market Dynamics Versus Patent Strategy

Aspect	Market Dynamics	Patent Landscape	Implication for Stakeholders
Innovation Pace	Moderate, with recent stagnation	Selective, focusing on formulations	Need for novel NCEs, strategic filings
Patent Expiries	Significant post-2000	Cliffs in key chemical classes	Pressure on generics and biosimilars sector
Resistance Trends	Accelerate demand for newer agents	Active patent filings for resistant strains	Opportunities for first-in-class drugs
Regulatory Buffer	Stringent, varying across regions	Patent extensions through formulation patents	Necessity to innovate within regulation

Key Takeaways

The global anthelmintic market is expanding, driven by parasitic disease burden, resistance, and increasing veterinary applications.
Patent expiries of cornerstone drugs like albendazole and ivermectin have led to a surge in generics, intensifying competition.
Innovations tend to focus on combination therapies, advanced formulations, and targeted delivery systems to combat resistance and improve efficacy.
The patent landscape reflects cautious yet strategic efforts in NCE development, with many patents focusing on formulation improvements rather than novel chemical entities.
Regulatory and policy frameworks significantly influence patent strategies, with patent extensions and data exclusivity providing competitive advantages.
Future growth hinges on overcoming resistance, navigating regulatory pathways efficiently, and harnessing biotech innovations like vaccines.

FAQs

1. How does patent expiry impact the availability of generic anthelmintics?

Patent expiry typically opens the market to generic manufacturers, reducing prices, increasing access, but also intensifying market competition. This often results in a decline in revenue for originators but provides opportunities for new patent filings on improving formulations or delivery systems.

2. What are the main challenges in developing new anthelmintic agents?

Primary challenges include resistance development, lengthy regulatory approval processes, high R&D costs, and difficulty demonstrating superior efficacy or safety over existing drugs.

3. Which regions present the most significant growth opportunities for P02 anthelmintics?

Developing regions in Africa, Southeast Asia, and Latin America, where helminth infections are endemic, offer substantial growth potential due to high disease burden and expanding veterinary markets.

4. Are there any recent breakthroughs in anthelmintic bandwiths?

While few NCEs have been introduced recently, advances in delivery technologies and combination therapies are promising, with some patents proposing long-acting formulations and vaccines under clinical trials.

5. How do patent strategies differ between human and veterinary anthelmintics?

Veterinary patents tend to focus more on delivery systems and formulations tailored for livestock, with a higher frequency of patent filings for combination therapies, while human drug patents often emphasize NCEs and targeted treatments.

References

WHO. Soil-transmitted helminth infections. Global health estimates, 2021.
MarketsandMarkets. Anthelmintics Market by Type, Application, and Region — COVID-19 Impact, 2022.
Vercruysse & Rew. Anthelmintic resistance in nematodes of livestock, Vet Parasitol, 2018.
US Patent No. 4,944,043. Albendazole formulations, Wyeth, 1990.
US Patent No. 4,029,561. Ivermectin composition, Merck, 1974.
Pfizer. Moxidectin patent filings, 2003–present.

[Note: The above compiled insights provide a comprehensive overview for professionals seeking detailed, actionable knowledge on the market and patent landscape of P02 anthelmintics.]

Drugs in ATC Class P02

Subclasses in ATC: P02 - ANTHELMINTICS

Market Dynamics and Patent Landscape for ATC Class P02 – Anthelmintics