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Drugs in ATC Class D04AX
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Drugs in ATC Class: D04AX - Other antipruritics
| Tradename | Generic Name |
|---|---|
| DOXEPIN HYDROCHLORIDE | doxepin hydrochloride |
| SILENOR | doxepin hydrochloride |
| SINEQUAN | doxepin hydrochloride |
| ZONALON | doxepin hydrochloride |
| >Tradename | >Generic Name |
D04AX Market Analysis and Financial Projection
The ATC class D04AX (Other antipruritics) encompasses drugs used to relieve itching that are not classified under antihistamines or anesthetics. This category includes systemic and topical agents like doxepin (D04AX01), a tricyclic antidepressant repurposed for antipruritic use. Below, we analyze the market dynamics and patent landscape for this therapeutic subgroup.
Market Dynamics of D04AX Drugs
COVID-19 Pandemic Impact
- Prescribing Patterns: During the pandemic, D04AX drugs saw volume decreases in regions like Romagna (–30.1%)[14], while structural market shifts influenced pack-size changes. For example, Lithuania’s shift toward smaller packs (–1.6%) was offset by market composition changes[1][7].
- Therapeutic Volume Trends: Analgesics (N02) and antimycotics (J02) dominated prescribing changes across Europe, but antipruritics faced declines linked to reduced dermatological consultations during lockdowns[1].
Packaging and Structural Shifts
- The average number of defined daily doses (DDDs) per pack increased in some countries due to shifts toward larger pack sizes. In Germany, structural market changes contributed +4.1% to pack-size growth[1][7].
Regulatory and Supply Factors
- Smaller markets, like Malta, rely on parallel imports and expedited authorizations (e.g., EU Article 126a) to maintain supply, highlighting vulnerabilities in drug availability for niche classes like D04AX[6].
Patent Landscape
Key Drug: Doxepin
- Patents: Doxepin’s formulation innovations include US10653660B2, which focuses on improving pharmacokinetics for insomnia treatment[12][13]. Other patents cover extended-release formulations and topical applications.
- Mechanism and Classification: While classified under D04AX for antipruritic use, doxepin also retains its psychiatric classification (N06AA12)[13], reflecting its dual therapeutic role.
Competitive Dynamics
- Expired Patents: Older patents (e.g., US6211229) have lapsed, enabling generic entry. However, newer patents targeting dermatological applications aim to extend market exclusivity[12][13].
- Pipeline Drugs: Difelikefalin, a κ-opioid receptor agonist, faced debates over its ATC classification (eventually placed in V03AX), highlighting regulatory challenges for novel antipruritics[15].
Market Outlook
- Growth Drivers: Aging populations and chronic dermatological conditions (e.g., eczema) may boost demand for D04AX drugs.
- Barriers: Regulatory complexity and competition from generics limit revenue potential. For example, doxepin’s cost remains low due to generic saturation[12].
- Innovation Trends: Focus on topical formulations and combination therapies (e.g., doxepin with moisturizers) to enhance efficacy and patentability[13][15].
Highlight: "Structural market shifts during COVID-19 influenced prescribing patterns, with pack-size adjustments reflecting both logistical challenges and long-term trends in dermatological care." [1][7]
Key Takeaways
- D04AX drugs faced volume declines during COVID-19, driven by reduced outpatient visits.
- Doxepin dominates the subclass, with patent activity focused on pharmacokinetic optimization.
- Regulatory decisions (e.g., ATC classification debates) significantly impact market access for new entrants.
FAQs
Q1: What is the primary use of D04AX drugs?
Antipruritics in this class treat itching associated with eczema, psoriasis, and allergic reactions.
Q2: Why did pack sizes increase in some EU countries during the pandemic?
Structural shifts toward larger packs (+4.1% in Germany) aimed to reduce dispensing frequency amid supply-chain disruptions[1][7].
Q3: Is doxepin available as a generic?
Yes, most doxepin formulations are generic, though novel delivery systems (e.g., low-dose oral films) remain patented[12][13].
Q4: How does ATC classification affect drug development?
Misclassification (e.g., difelikefalin’s placement in V03AX) can delay market entry and complicate prescribing[15].
Q5: Are there new antipruritics in development?
Yes, κ-opioid agonists and biologics targeting IL-31 are under study, though regulatory hurdles persist[15].
References
- https://pureportal.strath.ac.uk/files/172469678/Krulichova_etal_PDS_2022_Comparison_of_drug_prescribing_before_and_during_the_COVID_19_pandemic.pdf
- https://www.drugpatentwatch.com/p/atc-class/D04A
- https://www.metropolitan.co.bw/common_up/metropolitan-health/01-08-2017_BOTSOGO%20HEALTH%20PLAN%20MEDICINE%20PRICE%20LIST%202017.xlsx
- https://atcddd.fhi.no/filearchive/publications/1_2013guidelines.pdf
- https://en.wikipedia.org/wiki/ATC_code_D04
- https://www.um.edu.mt/library/oar/bitstream/123456789/118105/1/2327MDSPHR663705069682_1.PDF
- https://cris.unibo.it/bitstream/11585/907654/3/Comparison%20of%20drug%20prescribing%20before%20and%20during%20the%20COVID-19%20pandemic:%20A%20cross-national%20European%20study.pdf
- https://go.drugbank.com/drugs/DB01142
- https://github.com/norddrg/NDMS_workmaps/blob/master/text/ice/csp.TXT
- https://prediction.charite.de/subpages/tree.php
- https://ztl.nuph.edu.ua/wp-content/uploads/2019/11/%D0%A2%D0%B5%D1%85%D0%BD%D0%BE%D0%BB%D0%BE%D0%B3%D1%96%D1%87%D0%BD%D1%96-%D1%82%D0%B0-%D0%B1%D1%96%D0%BE%D1%84%D0%B0%D1%80%D0%BC%D0%B0%D1%86%D0%B5%D0%B2%D1%82%D0%B8%D1%87%D0%BD%D1%96-%D0%B0%D1%81%D0%BF%D0%B5%D0%BA%D1%82%D0%B8-%D1%81%D1%82%D0%B2%D0%BE%D1%80%D0%B5%D0%BD%D0%BD%D1%8F-%D0%BB%D1%96%D0%BA%D0%B0%D1%80%D1%81%D1%8C%D0%BA%D0%B8%D1%85-%D0%BF%D1%80%D0%B5%D0%BF%D0%B0%D1%80%D0%B0%D1%82%D1%96%D0%B2-%D1%80%D1%96%D0%B7%D0%BD%D0%BE%D1%97-%D0%BD%D0%B0%D0%BF%D1%80%D0%B0%D0%B2%D0%BB%D0%B5%D0%BD%D0%BE%D1%81%D1%82%D1%96-%D0%B4%D1%96%D1%97-2019.pdf
- https://patentimages.storage.googleapis.com/78/65/33/a6301f7269aa4f/US10653660.pdf
- https://pubchem.ncbi.nlm.nih.gov/compound/Cidoxepin
- https://cris.unibo.it/retrieve/d38ede64-ca6e-44d3-96d3-0eab14cb084c/pds5509-sup-0001-supinfo.pdf
- https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/atc-ddd/50th_atc_ddd_executive_summary.pdf?sfvrsn=aac14c8e_7
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