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Drugs in ATC Class N01BX
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Drugs in ATC Class: N01BX - Other local anesthetics
| Tradename | Generic Name |
|---|---|
| DYCLONE | dyclonine hydrochloride |
| DYCLOPRO | dyclonine hydrochloride |
| QUTENZA | capsaicin |
| >Tradename | >Generic Name |
Showing 1 to 3 of 3 entries
N01BX Market Analysis and Financial Projection
The ATC class N01BX ("Other local anesthetics") encompasses pharmaceutical agents like capsaicin, dyclonine, and ethyl chloride, which represent a niche but growing segment in pain management and procedural anesthesia. Below is an analysis of their market dynamics and patent landscape:
Market Dynamics
Global Growth Projections
The local anesthesia drugs market is projected to reach $4.7 billion by 2031, growing at a 6.4% CAGR from 2022, driven by increasing surgical/dental procedures and demand for non-opioid pain management[1][11]. Capsaicin—classified under N01BX04—is a key contributor, with its market expected to grow from $8.89 million (2024) to $17.83 million by 2037 at a 5.5% CAGR, fueled by applications in neuropathic pain and natural product trends[10].
Key Drivers
- Expanding Therapeutic Applications: Capsaicin is increasingly used for diabetic neuropathy and postherpetic neuralgia, supported by clinical studies showing efficacy in reducing chronic pain[10].
- Safety Profile Preference: Local anesthetics avoid systemic risks of general anesthesia, making them ideal for outpatient procedures[11].
- Emerging Formulations: Innovations like heated patches (e.g., Synera™ with lidocaine/tetracaine) enhance drug delivery[5].
Regional Demand
- Asia-Pacific: Dominates capsaicin consumption due to natural product demand[10].
- North America/Europe: Lead in surgical anesthesia adoption, with generic competition intensifying post-patent expirations[1][12].
Patent Landscape
Key Players and Innovations
| Company/Assignee | Drug/Technology | Patent Focus | Status |
|---|---|---|---|
| Pharmavax AS | Local anesthetic combinations | Optimized pain relief formulations | Pending (2024)[3] |
| Galderma Laboratories | S-Caine™ Patch | Heated lidocaine/tetracaine delivery | Discontinued (2008)[5] |
| ZARS Pharma | Synera™ | Temperature-activated delivery | Active[5] |
Notable Trends
- Patent Expirations: Dyclonine’s original patents (e.g., US 2,771,391) expired decades ago, enabling generic alternatives[7][12].
- New Entrants: 52 newcomers entered the broader bispecific antibody IP landscape since 2020, signaling innovation spillover into adjacent therapeutic areas[1][9].
Strategic Challenges
- EP Oppositions: Multiple European patent disputes reflect competitive pressures, particularly in formulation technologies[1][9].
- Regulatory Hurdles: 30% of blockchain-related patents face rejections under U.S. §101, a trend potentially affecting novel delivery mechanisms[17].
Clinical and Regulatory Insights
Mechanisms of Action
- Capsaicin: Targets TRPV1 receptors to deplete substance P in nociceptors, reducing pain signals[18].
- Dyclonine: Sodium channel blocker with rapid onset for mucosal anesthesia[7].
Approved Indications
- QUTENZA® (capsaicin): FDA-approved for postherpetic neuralgia[6].
- Dyclonine: Used for gag reflex suppression and oral ulcer pain[7].
Future Outlook
- Biosimilar/GENERIC Competition: Post-2030, patent cliffs for drugs like capsaicin will accelerate cost-driven market shifts[12].
- Technological Integration: AI-driven patent analytics (e.g., KnowMade’s IP reports) are becoming critical for strategic R&D planning[9].
- Sustainability Focus: Natural-derived agents like capsaicin align with eco-pharma trends, potentially gaining regulatory fast-tracking[10].
"The rise of non-opioid analgesics underscores a paradigm shift toward safer, targeted therapies." – Industry Analyst Commentary[11]
Key Takeaways
- N01BX drugs are gaining traction in chronic pain and procedural settings.
- Patent landscapes are fragmented, with legacy drugs facing generics and newer formulations prioritizing delivery innovations.
- Market growth hinges on expanding indications and overcoming regulatory/competitive barriers.
FAQs
- What distinguishes N01BX from other anesthetic classes?
Focus on non-traditional agents like capsaicin and dyclonine, often used for specialized pain syndromes[6][8]. - How long do local anesthetic patents typically last?
20 years from filing, adjustable via extensions (PTA/PTE)[12]. - Which companies lead in capsaicin production?
Glenmark, Pfizer, and Bayer dominate manufacturing[10]. - Are topical anesthetics safer than injectables?
Yes, due to localized action and reduced systemic exposure[5][11]. - What drives EP oppositions in this sector?
Competitive IP battles over formulation technologies and delivery systems[1][9].
References
- https://www.businesswire.com/news/molecularlab/20250224366580/en/Bispecific-Antibody-and-Cancer-Patent-Landscape-Analysis-2025-with-IP-Profiles-of-Key-Players-Amgen-Genentech-Roche-GenMab-Janssen-Regeneron-and-Xencor---ResearchAndMarkets.com
- https://www.metropolitan.co.bw/common_up/metropolitan-health/01-08-2017_BOTSOGO%20HEALTH%20PLAN%20MEDICINE%20PRICE%20LIST%202017.xlsx
- https://go.gale.com/ps/i.do?id=GALE%7CA809526312&sid=sitemap&v=2.1&it=r&p=HRCA&sw=w
- https://go.drugbank.com/drugs/DB03255
- https://iris.uniroma1.it/bitstream/11573/708466/1/Cantisani_New%20Patents_2014.pdf
- https://www.drugpatentwatch.com/p/atc-class/N01BX
- https://go.drugbank.com/drugs/DB00645
- https://atcddd.fhi.no/atc_ddd_index/?code=N01BX01
- https://www.knowmade.com/patent-analytics-services/patent-report/life-sciences-patent-landscape/bispecific-antibody-cancer-patent-landscape-analysis/
- https://www.researchnester.com/reports/capsaicin-market/3575
- https://www.alliedmarketresearch.com/press-release/local-anesthesia-drugs-market.html
- https://www.goodwinlaw.com/en/insights/blogs/2020/02/when-does-my-patent-expire
- https://www.drugpatentwatch.com/p/atc-class/N01
- https://www.metropolitan.co.bw/common_up/metropolitan-health/21-08-2017_Botsogo%20Health%20Plan%20Medicine%20Price%20List%202017.xlsx
- https://www.knowmade.com/patent-analytics-services/patent-report/life-sciences-patent-landscape/allogeneic-car-patent-landscape-analysis-2023/
- https://www.shipuniverse.com/news/lng-freight-rates-remain-depressed-amid-vessel-oversupply-and-market-dynamics/
- https://patentbusinesslawyer.com/blockchain-patent-landscape-comprehensive-guide-for-2024-and-2025/
- https://pubchem.ncbi.nlm.nih.gov/compound/Capsaicin
- https://testing.ehealthireland.ie/docs/hse/HSE9100-LOT2-IS-GENERAL_TERMINOLOGY-1.1.xlsx
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