Drugs in ATC Class N01AF

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Up to N - Nervous system

Up to N01 - ANESTHETICS

Up to N01A - ANESTHETICS, GENERAL

Drugs in ATC Class: N01AF - Barbiturates, plain

Tradename	Generic Name
BREVITAL SODIUM	methohexital sodium
METHOHEXITAL SODIUM	methohexital sodium
PENTOTHAL	thiopental sodium

N01AF Market Analysis and Financial Projection

The barbiturates classified under ATC code N01AF (Barbiturates, plain) occupy a specialized niche in anesthesia and sedation markets, characterized by declining clinical use but ongoing pharmaceutical relevance. Here's an analysis of their market dynamics and patent landscape:

Market Dynamics

Current Valuation & Growth Trajectory

• Global market size reached $472.9M in 2023, projected to grow at 3-3.7% CAGR through 2034[12][13][15][16]
• Key growth drivers:
  • Neurological disorder prevalence (50M epilepsy cases globally)[16]
  • Surgical anesthesia applications for ultra-short-acting variants[16]

Segmentation Insights

• By application:
  • Epilepsy treatment dominates with phenobarbital generating $303M by 2032[12]
  • Anesthesia accounts for $4.07B in general anesthetic spending (N01A class)[9]

Regional Landscape

• North America leads ($191.6M revenue in 2023)[12][14]
• Asia-Pacific emerging as fastest-growing region (3.9-5.3% CAGR in China/South Korea)[13]

Patent Landscape

Key Patents & Expirations

• Core patents expired for major N01AF agents:
  • Thiopental sodium: Patent lapsed, generic competition active[2][10]
  • Methohexital: Limited patent protection with multiple generics available[2]

Competitive Environment

• Dominant manufacturers:
  • Par Pharmaceutical
  • Akorn Operating Company LLC
  • Samarth Life Science[14][15]
• Market concentration: Top 5 players hold >60% revenue share[15]

Innovation Trends

• R&D focus shifting to non-barbiturate alternatives (benzodiazepines, propofol)[13][16]
• Recent developments:
  • Modified formulations for safer sedation protocols[12]
  • Niche applications in veterinary medicine (QN01AF90 thiamylal)[1][11]

Regulatory & Clinical Factors

• WHO Essential Medicines List includes thiopental for anesthesia[4][11]
• Prescription monitoring intensified due to abuse potential (0.31 DDD/1000 for addiction treatments)[9]

"Barbiturates remain vital in specific clinical scenarios despite broader market shifts toward safer alternatives." - WHO Guidelines on Essential Medicines[4]

Key Challenges

1. Therapeutic substitution: 34% decline in opioid combinations with barbiturates since 2004[9]
2. Regulatory constraints: Strictening controls on addictive substances[9][12]
3. Patent cliffs: No novel barbiturate patents filed since 2015[2][7]

Future Outlook

• Market stabilization expected through 2034 via:
  • Emerging economy healthcare expansion
  • Niche neurological applications
  • Cost-effective generic production[12][13]

The N01AF class exemplifies how legacy pharmaceutical agents maintain specialized roles despite broader therapeutic shifts, with market sustainability tied to generics and targeted clinical use cases.

References

1. https://en.wikipedia.org/wiki/ATC_code_N01
2. https://www.drugpatentwatch.com/p/atc-class/N01AF
3. https://atcddd.fhi.no/filearchive/publications/1_2013guidelines.pdf
4. https://list.essentialmeds.org/files/trs/KmctuAAMtPBorqeQRged3u44S6eeGKQPvOfhGr65.pdf
5. https://atcddd.fhi.no/filearchive/publications/2024_guidelines__final_web.pdf
6. https://www.ipcheckups.com/patent-landscape-analysis-how-to-5-steps/
7. https://www.knowmade.com/patent-analytics-services/patent-report/life-sciences-patent-landscape/allogeneic-car-patent-landscape-analysis-2023/
8. https://english.cnipa.gov.cn/module/download/downfile.jsp?classid=0&showname=13-Patent+Landscape_+China+and+Belt+and+Road+Partner+Countries+%282013-2023%29.pdf&filename=fbd6219df7de4ef8a817581c038eb211.pdf
9. https://pmc.ncbi.nlm.nih.gov/articles/PMC4584929/
10. https://journals.uran.ua/sr_pharm/article/download/286425/280612
11. https://www.drugsandalcohol.ie/29364/1/WHO%20Collaborating%20Centre%20for%20Drug%20Statistics%20Methodology.pdf
12. https://www.gminsights.com/industry-analysis/barbiturate-drugs-market
13. https://www.futuremarketinsights.com/reports/barbiturate-drug-market
14. https://www.mordorintelligence.com/industry-reports/barbiturate-drugs-market
15. https://www.polarismarketresearch.com/industry-analysis/barbiturate-drugs-market
16. https://www.grandviewresearch.com/industry-analysis/barbiturate-drugs-market-report