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Drugs in ATC Class D11AX
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Drugs in ATC Class: D11AX - Other dermatologicals
| Tradename | Generic Name |
|---|---|
| MEN'S ROGAINE | minoxidil |
| MINOXIDIL | minoxidil |
| MINOXIDIL (FOR MEN) | minoxidil |
| MINOXIDIL (FOR WOMEN) | minoxidil |
| MINOXIDIL EXTRA STRENGTH (FOR MEN) | minoxidil |
| WOMEN'S ROGAINE | minoxidil |
| >Tradename | >Generic Name |
Showing 1 to 6 of 6 entries
D11AX Market Analysis and Financial Projection
The market dynamics and patent landscape for drugs classified under ATC Class D11AX - Other dermatologicals reflect a rapidly evolving sector driven by innovation in dermatological treatments, strategic patent management, and shifting regulatory requirements. This category includes diverse preparations for conditions like male pattern baldness (e.g., minoxidil), actinic keratoses (e.g., diclofenac gel), and hyperpigmentation (e.g., Defensage’s defensin-based products).
Market Growth Drivers
- Expanding therapeutic applications: The D11AX category addresses niche dermatological needs, with minoxidil and finasteride for hair loss accounting for significant adoption. The global dermatological products market is projected to grow at a CAGR of 5.4% (2022–2032), driven by rising demand for acne, psoriasis, and anti-aging treatments[3][11].
- Biologics and biosimilars: Over 10 biologics are approved for moderate-to-severe psoriasis, while biosimilars like adalimumab biosimilars are reducing costs and increasing accessibility[3][11].
- Dermo-cosmetic innovations: Products combining cosmetic and therapeutic benefits, such as preservative-free formulations and Device for Exclusive Formula Integrity (D.E.F.I) packaging, are capturing 2/5th of additional demand by aligning with dermatologist recommendations[3].
Patent Landscape and Innovation
- Drug repositioning: Companies leverage failed candidates for new uses, such as thalidomide for leprosy or sildenafil for erectile dysfunction[2]. DefenAge’s recent patents for defensin-molecules in hair growth and melasma exemplify this trend[4].
- Strategic patenting:
- Composition of Matter (COM) patents protect chemical structures (e.g., minoxidil)[2][4].
- Method of Use (MOU) patents cover novel applications, such as diclofenac gel for actinic keratoses under D11AX[6][8].
- Generic competition: After patent expiry, products like ivermectin (used off-label for rosacea) face price erosion. Over 40% of D11AX drugs have generic equivalents, prompting originators to focus on formulation patents (e.g., extended-release minoxidil)[14][5].
Regulatory and Utilization Considerations
- ATC/DDD system updates: Annual updates to ATC codes and Defined Daily Doses (DDDs) require manufacturers to adjust historical data and ensure cross-country comparability. For example, finasteride’s low-strength formulation is classified under D11AX, while its high-strength version falls under G04C[1][7].
- Topical vs. systemic classifications: Most D11AX drugs are topical and lack DDDs due to variable dosing. Utilization metrics instead rely on grams consumed[6][9].
Key Challenges
- Patent cliffs: Drugs like finasteride (D11AX10) face generic erosion post-2025, threatening $1.2B in annual revenue[5][11].
- Rebate dynamics: Rebates for dermatological drugs grew by 3.2 percentage points annually from 2012–2017, squeezing manufacturer margins[5].
Future Outlook
- Personalized treatments: Targeted therapies using biomarkers and nanotechnology (e.g., hyaluronic acid gels) are expected to dominate R&D[3].
- Emerging markets: Asia-Pacific is projected to grow at 8.2% CAGR (2023–2030) due to rising skin disorder prevalence and awareness campaigns[11].
"Extended research proves that Defensin-molecules naturally awaken dormant skin cells and spark a regenerative response" — Gregory Keller, MD[4].
By integrating advanced formulations, strategic IP management, and compliance with ATC/DDD updates, stakeholders can navigate this dynamic market effectively.
References
- https://www.who.int/tools/atc-ddd-toolkit/start-using
- https://repo.lib.semmelweis.hu/bitstream/handle/123456789/6436/aranyadam.d_DOIs.pdf?sequence=1
- https://www.factmr.com/report/2363/dermatological-products-market
- https://www.dermatologytimes.com/view/defenage-receives-2-us-patents
- https://www.nber.org/system/files/working_papers/w26846/w26846.pdf
- https://atcddd.fhi.no/atc_ddd_index/?code=D11AX08
- https://muria.mandela.ac.za/getmedia/d1b8b39d-af03-4bbf-b173-7ec21bc1ad4b/Oluka-ATC-DDD?disposition=attachment
- https://atcddd.fhi.no/atc_ddd_index/?code=D11AX21
- https://atcddd.fhi.no/atc_ddd_index/?showdescription=yes&code=D11A
- https://atcddd.fhi.no/atc_ddd_index/?code=D11AX&showdescription=yes
- https://www.fortunebusinessinsights.com/dermatology-drugs-market-104432
- https://atcddd.fhi.no/atc_ddd_index/?code=D11AX52
- 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/generic-api/ivermectin
- https://en.wikipedia.org/wiki/Patent_analysis
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