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Drugs in ATC Class N05CE
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Drugs in ATC Class: N05CE - Piperidinedione derivatives
| Tradename | Generic Name |
|---|---|
| DORIDEN | glutethimide |
| GLUTETHIMIDE | glutethimide |
| NOLUDAR | methyprylon |
| >Tradename | >Generic Name |
Showing 1 to 3 of 3 entries
N05CE Market Analysis and Financial Projection
The market dynamics and patent landscape for ATC Class N05CE (Piperidinedione derivatives) reflect a niche segment within the sedative-hypnotic category, shaped by historical use, safety concerns, and evolving pharmaceutical trends. Here's a detailed analysis:
Market Dynamics
Current Market Status
- Declining Clinical Use: Piperidinedione derivatives like glutethimide and methyprylon were once used for insomnia but are now rarely prescribed due to high addiction potential, overdose risks, and the availability of safer alternatives (e.g., benzodiazepines, non-benzodiazepine hypnotics)[13][16]. Methyprylon was discontinued in the U.S. in 1993, while glutethimide production ceased in 1993 (U.S.) and 2006 (Eastern Europe)[13][16].
- Piperidine Market Context: The broader piperidine market (valued at $64M in 2022, projected to reach $86M by 2027 at 5.9% CAGR) includes derivatives used in pharmaceuticals, agrochemicals, and solvents[3]. While N05CE drugs are not primary drivers, their structural analogs remain relevant in drug synthesis[7].
Key Challenges
- Safety and Regulation: Both drugs are classified as Schedule II controlled substances in the U.S., with glutethimide linked to fatal combinations (e.g., with codeine)[16]. Regulatory hurdles and post-market surveillance (e.g., PASS studies for cardiovascular risks, as seen in COPD drugs like NVA237[1]) limit commercial viability.
- Generic Competition: With patents expired and no recent exclusivity extensions, generic alternatives dominate residual markets. However, demand remains minimal due to clinical obsolescence[14].
Patent Landscape
Historical and Expired Patents
- Original Patents: Early patents for glutethimide (Doriden) and methyprylon (Noludar) have long expired. For example, glutethimide synthesis methods were patented in the 1950s[16], while methyprylon’s use as a sedative was covered under now-lapsed patents[13].
- Secondary Strategies: While newer patents on delivery devices or formulations are common for blockbuster drugs (e.g., GLP-1 agonists[14]), such strategies are absent for N05CE drugs due to limited commercial interest.
Emerging Innovations
- Novel Derivatives: Patent WO2015140133A1 (2015) highlights piperidine-dione derivatives with antineoplastic potential, indicating a shift toward oncology applications rather than CNS disorders[9].
- Regional Activity: China dominates piperidine production[3], but no significant N05CE-related patent filings are noted in recent years.
Competitive Landscape
- Key Players: Companies like Jubilant Ingrevia (India) and Vertellus (U.S.) lead in piperidine production[3], though not specifically for N05CE drugs.
- Abandoned Markets: Major pharmaceutical firms have exited N05CE drug production. For instance, Ciba (glutethimide) and Roche (methyprylon) discontinued these products decades ago[16][13].
Future Outlook
- Repurposing Potential: Research into piperidinedione derivatives for non-sedative applications (e.g., cancer therapy[9]) could revitalize interest, though clinical adoption remains speculative.
- Regulatory Barriers: Stricter safety protocols and the rise of non-addictive sleep aids (e.g., melatonin receptor agonists) further marginalize N05CE drugs[4][8].
Key Takeaways
- N05CE drugs are largely obsolete, with markets constrained by safety issues and generics.
- The broader piperidine market thrives due to pharmaceutical and agrochemical demand, but not directly through N05CE-class agents.
- Patent activity focuses on novel derivatives for non-CNS indications, though commercial impact is yet to materialize.
"The decline of piperidinedione derivatives underscores the pharmaceutical industry's shift toward safer, more targeted therapies." [7][16]
References
- https://catalogues.ema.europa.eu/sites/default/files/document_files/NVA237A2402T-v03--protocol_Redacted.pdf
- https://www.ngb.co.jp/en/resource/news/4203/
- https://www.marketsandmarkets.com/Market-Reports/piperidine-market-262881406.html
- https://atcddd.fhi.no/atc_ddd_index/?code=N05CE&showdescription=yes
- https://atcddd.fhi.no/filearchive/publications/2025_guidelines__final_web.pdf
- https://www.knowmade.com/patent-analytics-services/patent-report/gan-electronics-patent-landscape-analysis-2023/
- https://www.vasudhapharma.com/piperidone-piperidine-derivatives.php
- https://www.bionity.com/en/encyclopedia/ATC+code+N05.html
- https://patents.google.com/patent/WO2015140133A1/en
- https://www.alliedmarketresearch.com/patented-drugs-market-A110993
- https://www.promarketreports.com/reports/n-butylpyrrolidinone-43509
- https://patentimages.storage.googleapis.com/60/25/19/9bc9339f291d9b/US6165500.pdf
- https://www.pharmacompass.com/active-pharmaceutical-ingredients/methyprylon
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11457043/
- https://www.trade.gov/pharmaceuticals-and-biopharmaceuticals
- https://en.wikipedia.org/wiki/Glutethimide
- https://synapse.patsnap.com/drug/c50f12e535b84952bced436dab8b2fd2
- https://www.pharmacompass.com/chemistry-chemical-name/glutethimide
- https://www.maximizemarketresearch.com/market-report/glutethimide-market/148578/
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