Drugs in ATC Class N02AB

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Drugs in ATC Class: N02AB - Phenylpiperidine derivatives

Tradename	Generic Name
DURAGESIC-100	fentanyl
DURAGESIC-12	fentanyl
DURAGESIC-25	fentanyl
DURAGESIC-37	fentanyl
DURAGESIC-50	fentanyl
FENTANYL CITRATE AND DROPERIDOL	droperidol; fentanyl citrate
INNOVAR	droperidol; fentanyl citrate

N02AB Market Analysis and Financial Projection

The market dynamics and patent landscape for ATC Class N02AB (phenylpiperidine derivatives) reveal a complex interplay of evolving prescription trends, strategic patenting, and competitive pressures in both medical and illicit markets. Here’s an in-depth analysis:

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Market Dynamics of Phenylpiperidine Derivatives

N02AB opioids, including fentanyl, pethidine, and ketobemidone, are critical for pain management but exhibit distinct consumption patterns:

• Fentanyl dominates prescriptions: In La Gomera, Spain (2016–2019), fentanyl accounted for 6.29% of total opioid units sold but contributed 14.87% of defined daily doses (DID) due to its high potency[1][7]. Transdermal patches (delivering 1.2 mg/day) were the most prescribed formulation, alongside tablets[1][7].
• Demand shifts: Long-acting formulations (e.g., transdermal patches) gained prominence, while nasal spray use remained minimal (1.31% in 2019)[7]. Tramadol combinations (N02AJ) overshadowed N02AB in unit sales but not potency-adjusted metrics[1].
• Illicit markets: Fentanyl represented 10% of opioid listings on darknet markets like Dream Market, with high overdose risks due to unregulated production[13].

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Patent Landscape and Strategic Evergreening

The patent strategy for phenylpiperidine derivatives focuses on formulation innovations to extend market exclusivity:

• Expired compound patents: Fentanyl’s original compound patent expired in 1982[15], but developers secured secondary patents for delivery systems (e.g., transdermal matrix patches under EP1381352B1, granted in 2007)[15].
• Litigation and competition: Companies like Janssen defended matrix patch patents against generics in Europe, delaying market entry until patent revocations[15]. Similar strategies apply to pethidine combinations (N02AB52/72)[2].
• Generics impact: Post-patent expiration, fentanyl saw 38–48% price declines for physician-administered forms and 25% for oral doses, with generic manufacturers capturing market share[14].

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Key Trends and Challenges

1. Formulation-driven markets:	Drug	Primary Formulation	Market Share (DID)
   Fentanyl	Transdermal patches	14.87%[1]
   Pethidine	Injectable solutions	<0.001%[1]

   Innovations like buccal tablets and depot patches aim to prolong patent life[16].

2. Regulatory and illicit pressures:

   • Tightening regulations target illicit fentanyl, but darknet markets persist due to low production costs and high potency[13].
   • Patent landscape analyses (sources 8–9) help identify “white spaces” for generics and novel drug development, particularly in understudied therapeutic areas[6][8].

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Future Outlook

• R&D diversification: While phenylpiperidine derivatives are traditionally CNS-focused, patent filings suggest potential in oncology (e.g., imatinib mesylate)[3] and anti-inflammatory applications[6].
• Generic competition: With 21 U.S. patents for fentanyl expiring, 8 suppliers currently offer generic versions, driving price erosion[16].
• Global disparities: Spain’s opioid consumption (19.83 DID in 2019) aligns with La Gomera’s trends, but regional prescribing habits vary widely[1][5].

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"The synthetic opioid revolution combines efficiency in illicit production with global distribution networks, complicating regulatory efforts"[13].

This landscape underscores the tension between innovation, access, and regulation in pain management therapeutics.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC8758613/
2. https://atcddd.fhi.no/atc_ddd_index/?showdescription=yes&code=N02AB
3. https://www.proquest.com/scholarly-journals/innovations-patent-trends-development-usfda/docview/2565483869/se-2
4. https://patents.google.com/patent/US5250542A/en
5. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1184457/pdf
6. https://pubmed.ncbi.nlm.nih.gov/22957817/
7. https://assets-eu.researchsquare.com/files/rs-484651/v1/12f900bb-3556-4968-8baa-740710ac37ad.pdf?c=1631882515
8. https://www.ipcheckups.com/patent-landscape-analysis-overview/
9. https://caldwelllaw.com/news/how-patent-landscape-analysis-drives-business-growth/
10. https://www.drugpatentwatch.com/p/generic-api/FENTANYL
11. https://stealthagents.com/competitive-market-analysis-questions/
12. https://www.unodc.org/unodc/en/data-and-analysis/bulletin/bulletin_1956-01-01_1_page006.html
13. https://www.aic.gov.au/sites/default/files/2020-05/ti590_fentanyl_availability_on_darknet_markets.pdf
14. https://www.nber.org/digest/sep14/patent-expiration-and-pharmaceutical-prices
15. https://ec.europa.eu/competition/antitrust/cases/dec_docs/39685/39685_1976_7.pdf
16. https://www.drugpatentwatch.com/p/generic-api/fentanyl
17. http://indiaenvironmentportal.org.in/files/Evergreening.pdf