Drugs in ATC Class C05AX

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Up to C05A - AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE

Drugs in ATC Class: C05AX - Other agents for treatment of hemorrhoids and anal fissures for topical use

Tradename	Generic Name
ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride
ADVIL MULTI-SYMPTOM COLD & FLU	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride
PHENERGAN VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
PHERAZINE VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride

C05AX Market Analysis and Financial Projection

The market for ATC Class C05AX (Other agents for treatment of hemorrhoids and anal fissures for topical use) is experiencing steady growth, driven by increasing prevalence of anorectal disorders and advancements in non-invasive therapies. Below is an analysis of its market dynamics and patent landscape:

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Market Dynamics

1. Market Size and Growth

• The global anal fissure treatment market, inclusive of C05AX agents, was valued at $1.38 billion in 2023 and is projected to reach $1.49–1.96 billion by 2029–2030, growing at a 5.3–6.2% CAGR [3][7].
• Topical therapies dominate due to their non-invasive nature, cost-effectiveness, and patient preference for self-administered treatments [3][7].

2. Key Segments

• Treatment Type: Topical nitrates (e.g., nitroglycerin) hold the largest market share, favored for their efficacy in relaxing anal sphincter muscles [3].
• Route of Administration: Topical applications account for >60% of the market, driven by localized drug delivery and minimal systemic side effects [3][7].

3. Regional Insights

• North America and Europe lead due to advanced healthcare infrastructure and higher treatment adoption rates [7].
• Asia-Pacific shows rapid growth, fueled by increasing awareness and healthcare spending [3].

4. Drivers

• Rising incidence of hemorrhoids (linked to sedentary lifestyles, obesity) and anal fissures (from chronic constipation) [3][7].
• Technological advancements in formulations (e.g., sustained-release gels, mucoadhesive polymers) improving patient compliance [8][9].

5. Competitive Landscape

• Major players: Abbvie, Novartis, Teva Pharmaceuticals, and Peritech Pharma [7].
• Recent innovations: Peritech’s PP-110 (a patented OTC gel with slow-release mechanisms) demonstrated superior efficacy over conventional treatments in clinical trials [11].

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Patent Landscape

1. Key Patents and Innovations

• CA3098256C / WO2019207059A1: Covers topical compositions combining anal dilators (e.g., diltiazem) with mucoadhesive polymers (e.g., chitosan) in non-aqueous vehicles for prolonged therapeutic effect [4][8].
• US11865207: Grants protection for Ferring B.V.’s formulation targeting post-hemorrhoidectomy recovery [9].
• PP-110 Patent (US9072747): Protects Peritech’s film-based gel for hemorrhoids, valid until 2034 [11].

2. Technological Trends

• Focus on enhanced drug delivery: Patents emphasize prolonged retention (e.g., using propylene glycol) and reduced application frequency [4][8].
• Combination therapies: Integrating anti-inflammatory agents (e.g., zinc oxide) with sphincter relaxants [13].

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Challenges and Opportunities

• Regulatory Hurdles: Stricter guidelines for OTC approvals and safety profiling [11][13].
• Emerging Therapies: Biologics (e.g., stem cell therapy) and regenerative medicine present future growth avenues [3].
• Market Expansion: Untapped potential in developing economies with high disease burden but low treatment access [7].

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Key Takeaways

• The C05AX market is buoyed by patient preference for non-surgical options and continuous R&D in topical formulations.
• Patent filings highlight innovation in drug delivery systems, with a focus on improving efficacy and compliance.
• Strategic collaborations and geographic expansion will be critical for stakeholders to capitalize on growth opportunities.

References

1. https://pubchem.ncbi.nlm.nih.gov/compound/Phenylephrine
2. https://www.metropolitan.co.bw/common_up/metropolitan-health/01-08-2017_BOTSOGO%20HEALTH%20PLAN%20MEDICINE%20PRICE%20LIST%202017.xlsx
3. https://www.researchandmarkets.com/reports/5987757/anal-fissure-treatment-market-global-industry
4. https://patents.google.com/patent/CA3098256C/en
5. https://archive.org/download/storyofcropeared10maca/storyofcropeared10maca.pdf
6. https://www.julkari.fi/bitstream/handle/10024/143552/Finnish_statistics_on_medicines_2020.pdf?sequence=1andisAllowed%3Dy
7. https://www.coherentmarketinsights.com/industry-reports/anal-fissure-treatment-market
8. https://patents.google.com/patent/WO2019207059A1/en
9. https://patents.justia.com/patents-by-us-classification/514/882
10. https://www.jpmorgan.com/insights/global-research/outlook/market-outlook
11. https://www.biospace.com/b-peritech-pharma-s-b-novel-hemorrhoids-treatment-shown-superior-to-preparation-h-in-pivotal-trial
12. https://atcddd.fhi.no/filearchive/publications/2025_guidelines__final_web.pdf
13. https://www.medicines.org.uk/emc/product/1487/smpc
14. https://www.digar.ee/arhiiv/et/download/192177