Drugs in ATC Class V04CX

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Drugs in ATC Class: V04CX - Other diagnostic agents

Tradename	Generic Name
IC-GREEN	indocyanine green
INDOCYANINE GREEN	indocyanine green
INFUVITE ADULT	alpha-tocopherol acetate; ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a palmitate; vitamin k
SPY AGENT GREEN KIT	indocyanine green

V04CX Market Analysis and Financial Projection

The ATC class V04CX ("Other diagnostic agents") encompasses a diverse group of agents used for specialized diagnostic purposes, including indocyanine green (liver function tests), folic acid (folate deficiency assessment), methacholine (airway hyperresponsiveness testing), and patent blue V (lymph node mapping). Here's an analysis of its market dynamics and patent landscape:

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Market Dynamics

Growth Drivers

• Rising demand for precision diagnostics: Agents like indocyanine green (ICG) saw expanded use in fluorescence-guided surgeries, with the global diagnostic reagents market projected to reach $62.8B by 2025 (CAGR: 5.9% in the U.S., 12.2% in India)[10][14].
• Chronic disease burden: Increased need for tests using agents like methacholine (asthma diagnostics) and mannitol (lung function tests)[14].
• Emerging markets: India and Southeast Asia showed rapid growth (CAGR 10-12%) due to healthcare infrastructure expansion[10].
• Technological advancements: Novel formulations like water-resistant diagnostic films ([US3630957A][4]) improved reliability in detecting biochemical components.

Market Restraints

• Regulatory challenges: Stringent requirements for diagnostic agent approvals delayed commercialization[14].
• Allergy risks: Patent blue V carries warnings for hypersensitivity reactions, limiting its adoption despite 82.9% efficacy in sentinel node biopsies[16].
• Generic competition: Folic acid, a V04CX02 agent, faces price pressures with multiple generic entrants post-patent expiration[2].

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Patent Landscape

Key Trends

• Expired patents: Older agents like folic acid (generic since 2009) and methacholine have open patent landscapes, enabling cost-effective alternatives[2].
• Active innovation: Recent patents focus on:
  • Novel delivery systems: E.g., polyvinyl propionate-based diagnostic films for blood/urine testing[4].
  • Combination techniques: Dual tracer methods (e.g., patent blue V + radiopharmaceuticals) to improve accuracy[16].

Regional Patent Strategies

• Europe: Harmonized regulatory pathways via the EMA streamlined approvals, though post-Brexit divergence poses challenges[12].
• U.S.: Patent cliffs for legacy agents (e.g., IC-Green) led to biosimilar development, while newer agents like pafolacianine (V04CX10) retain exclusivity[8][9].

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Comparative Analysis of Key Agents

Agent (ATC Code)	Primary Use	Patent Status	Market Trend
Indocyanine green (V04CX01)	Liver function, angiography	Expired (generics available)	Growing in fluorescence imaging[8][9]
Patent blue V (V04CX09)	Lymph node mapping	Formulation patents expired	Declining due to allergy risks[16]
13C-urea (V04CX05)	H. pylori detection	Active (method-of-use patents)	Rising demand in gastroenterology[1]
Pafolacianine (V04CX10)	Ovarian cancer detection	Under patent protection (2030+)	High growth in oncology[1][7]

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Future Outlook

• Personalized medicine: DNA-based diagnostic agents (e.g., hexaminolevulinate for bladder cancer) are gaining traction[1][14].
• AI integration: Machine learning platforms optimize diagnostic reagent formulations, reducing R&D timelines[14].
• Sustainability focus: Biodegradable reagents (e.g., sodium alginate films[4]) align with green chemistry trends.

"The shift toward minimally invasive diagnostics will amplify demand for imaging-centric V04CX agents like ICG." – Cognitive Market Research (2025)[10]

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Key Takeaways
The V04CX class faces bifurcation: commoditized agents (folic acid) compete on cost, while novel tracers (pafolacianine) leverage exclusivity. Regulatory harmonization and allergy-mitigation strategies will shape next-generation products.

References

1. https://atcddd.fhi.no/atc_ddd_index/?code=V04CX&showdescription=yes
2. https://www.drugpatentwatch.com/p/generic/folic+acid
3. https://www.atccode.com/V04C
4. https://patents.google.com/patent/US3630957A/en
5. https://www.drugsandalcohol.ie/29364/1/WHO%20Collaborating%20Centre%20for%20Drug%20Statistics%20Methodology.pdf
6. https://publications.gc.ca/collections/collection_2016/cepmb-pmprb/RG79-1-1998-eng.pdf
7. https://www.drugpatentwatch.com/p/atc-class/V04C
8. https://pubchem.ncbi.nlm.nih.gov/compound/5284572
9. https://pubchem.ncbi.nlm.nih.gov/compound/IC-Green
10. https://www.cognitivemarketresearch.com/diagnostic-reagents-market-report
11. https://aei.pitt.edu/49838/1/1997.pdf
12. https://pmc.ncbi.nlm.nih.gov/articles/PMC8465965/
13. https://www.ema.europa.eu/ga/media/64383
14. https://www.databridgemarketresearch.com/reports/global-diagnostic-reagents-market
15. https://atcddd.fhi.no/atc_ddd_index/?code=V04C&showdescription=no
16. https://womenshealth.guerbet.com/media/tnroljvd/gue-bpv_brochure_a5_0319_pages.pdf