Drugs in ATC Class P02CF

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Drugs in ATC Class: P02CF - Avermectines

Tradename	Generic Name
IVERMECTIN	ivermectin
SKLICE	ivermectin
SOOLANTRA	ivermectin
STROMECTOL	ivermectin

P02CF Market Analysis and Financial Projection

The market dynamics and patent landscape for ATC Class P02CF (Avermectines) reflect a complex interplay of growth drivers, regulatory factors, and evolving competition. Here's a comprehensive analysis:

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Market Dynamics

1. Current Market Valuation
   The global ivermectin market (the primary drug in P02CF) was valued at USD 1.04 billion in 2025, with a projected CAGR of 10.29% driven by rising parasitic infections in humans and animals[10]. Key segments include:

   • Veterinary applications: Dominates due to high demand for livestock and pet parasite control.
   • Human applications: Growing use for conditions like onchocerciasis and strongyloidiasis[2][10].

2. Regional Demand

   • Asia-Pacific: Expected to lead growth due to increased livestock production and awareness of antiparasitic treatments[10].
   • Africa: High burden of neglected tropical diseases amplifies reliance on WHO-recommended avermectins like ivermectin[4][8].

3. Supply-Demand Challenges

   • Overcapacity: Production oversupply in China (e.g., 3,600 tons produced vs. 2,800 tons demand) led to price drops of 28.6% for avermectin powder and 16.7% for emamectin benzoate[13].
   • Price volatility: Aggressive pricing strategies by manufacturers during peak seasons destabilized markets[13].

4. Innovation Trends

   • New formulations: Topical creams (e.g., Soolantra for rosacea) and injectables[11].
   • Expanding applications: Research into antiviral (e.g., COVID-19) and neurological uses (e.g., patent WO2021142425A1 for neurodegenerative disorders)[15].

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Patent Landscape

1. Key Expirations (2025)

   • Tudorza Pressair and Duaklir Pressair (Covis Pharma): Patents expire in February 2025, likely accelerating generic competition[14].

2. Manufacturing Patents

   • Streptomyces avermitilis: Patents cover bacterial strains engineered to produce natural and non-natural avermectins (e.g., US5565359A)[12].
   • Process innovations: Methods for optimizing fermentation yields and novel substitutions at the 25-position of avermectin molecules[9][12].

3. Emerging Applications

   • Neurological disorders: A 2025 patent (WO2021142425A1) proposes ivermectin for Alzheimer’s and Parkinson’s disease, signaling potential diversification[15].

4. Regulatory Protections

   • Drug Master Files (DMFs): Critical for API manufacturers to comply with regional standards (e.g., Japan’s JDMF, Europe’s CEP)[5].
   • NDC codes: Required for U.S. market entry, ensuring transparency in drug listings[5].

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Regulatory and Global Health Factors

1. WHO Essential Medicines List (EML)
   Ivermectin is included for parasitic infections, reinforcing its accessibility in low-resource settings[4][8]. Initiatives like UNITAID’s patent pool aim to improve affordability in developing regions[4].

2. ATC Classification

   • P02CF: Classifies avermectines under antinematodal agents, aligning with their use against roundworms and hookworms[1][3].
   • Defined Daily Dose (DDD): Standardized dosing (e.g., 12 mg oral DDD for ivermectin) ensures consistent therapeutic benchmarking[3][6].

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Competitive Landscape

• Key players: Merck (Stromectol), Galderma (Soolantra), and generic manufacturers[11].
• Market concentration: Moderately concentrated, with innovation and M&A shaping strategies (e.g., Covis Pharma’s acquisitions)[10][14].
• Threats: Generic entry post-2025 and substitute antiparasitics (e.g., benzimidazoles)[10].

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Key Takeaways

• Growth drivers: Rising parasitic disease burden and expansion into non-traditional applications.
• Challenges: Oversupply, price instability, and patent expirations.
• Future outlook: Sustainability hinges on regulatory harmonization, novel therapeutic applications, and balancing production capacity with demand.

"The imbalance between supply and demand has had a profound impact on the avermectin market" – ArticlesFactory[13].

References

1. https://icdcode.info/atc-ddd/index-p02cf.html
2. https://go.drugbank.com/drugs/DB00602
3. https://atcddd.fhi.no/atc_ddd_index/?code=P02CF01
4. https://list.essentialmeds.org/files/trs/Ny8eU2gkJAmi85MnjL3R9naY4LWvnpKREcroWn6m.pdf
5. https://www.pharmacompass.com/active-pharmaceutical-ingredients/ivermectin
6. https://atcddd.fhi.no/filearchive/publications/2025_guidelines__final_web.pdf
7. https://prediction.charite.de/subpages/tree.php
8. https://list.essentialmeds.org/files/trs/KmctuAAMtPBorqeQRged3u44S6eeGKQPvOfhGr65.pdf
9. https://patentimages.storage.googleapis.com/34/77/60/ff4ffbcb9dc978/EP0284176A2.pdf
10. https://www.promarketreports.com/reports/ivermectin-market-12632
11. https://www.drugpatentwatch.com/p/atc-class/P02CF
12. https://patents.google.com/patent/US5565359A/en
13. https://www.articlesfactory.com/articles/gardening/avermectin-market-is-rising.html
14. https://www.pharmamanufacturing.com/home/article/55249347/key-drugs-losing-patent-protection-in-2025
15. https://patents.google.com/patent/WO2021142425A1/en