Drugs in ATC Class D07AB

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Drugs in ATC Class: D07AB - Corticosteroids, moderately potent (group II)

Tradename	Generic Name
FLUOR-OP	fluorometholone
FLUOROMETHOLONE	fluorometholone
FML	fluorometholone
HYDROCORTISONE BUTYRATE	hydrocortisone butyrate
LOCOID	hydrocortisone butyrate
LOCOID LIPOCREAM	hydrocortisone butyrate
OXYLONE	fluorometholone

D07AB Market Analysis and Financial Projection

The market dynamics and patent landscape for ATC Class D07AB (corticosteroids, moderately potent, group II) reflect a growing dermatological sector driven by rising skin disease prevalence and ongoing pharmaceutical innovation, balanced by challenges like generic competition and formulation limitations.

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Market Dynamics

Growth Projections
The global topical corticosteroids market, including D07AB-class drugs like desonide and triamcinolone, is projected to grow at a 6.1% CAGR, reaching $6.42 billion by 2030[10]. Key drivers include:

• Increasing prevalence of eczema and atopic dermatitis, affecting 31.6 million people in the U.S. alone[10].
• R&D advances, such as combination therapies (e.g., Eli Lilly’s Lebrikizumab + topical corticosteroids)[10].

Competitive Landscape

• Major players like Almirall (Verdeso), Galderma (DesOwen), and Leo Pharma (Desonate) dominate with branded formulations[8].
• Generic penetration is rising: desonide, for example, faces competition from 17 suppliers of bulk APIs and 60 raw ingredient vendors[8].

Challenges

• Side effects (e.g., skin atrophy) and high R&D costs hinder adoption[10].
• Dosing variability in chronic use complicates market expansion[4].

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Patent Landscape

Key Patents and Innovations

1. Formulation Patents:

   • US Patent 11,439,590 (2022) covers corticosteroid-antibiotic combinations (e.g., D07CB subclass) using Poloxamer excipients for ocular applications[11].
   • US Patent 8,809,307B2 (2014) describes low-concentration, high-efficacy formulations for pediatric safety, exemplified by halobetasol but applicable to group II agents[13].

2. Synthesis Patents:

   • US-10112970-B2 (2018) outlines a streamlined process for producing 17-desoxy corticosteroids, including D07AB-class drugs like clocortolone[3].

3. Lifecycle Management:

   • Desonide holds 3 U.S. patents with exclusivity expiring in 2024–2025, while generics like clobetasone face Paragraph IV challenges[8].

Strategic Trends

• Repositioning of failed compounds into dermatology (e.g., branched development programs) is rising to offset R&D risks[2].
• Geographic Expansion: Patent filings in 33 countries (EU, Canada, Mexico) aim to capture emerging markets[11].

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Clinical and Regulatory Insights

• Efficacy: Moderately potent corticosteroids (group II) show 52% treatment success in inflammatory skin diseases versus 34% for mild agents[4].
• Guidelines: Classified by clinical potency, D07AB agents avoid combinations with antifungals/antibiotics (assigned to other ATC groups)[5][6].

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Future Outlook

• Combination Therapies: Expect growth in D07BB/D07CB (antiseptic/antibiotic combos) for infections complicating dermatitis[1][9].
• Biologics Competition: IL-13/IL-4 inhibitors may reduce corticosteroid reliance, though synergies (e.g., Lebrikizumab + TCS) offer co-therapy potential[10].

“The Patent Office recognized that our advanced engineering technology results in both an effective and highly stable formula.” – Jeffrey Liegner, MD, on corticosteroid-antibiotic eye drops[11].

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This sector balances innovation in formulation and synthesis with generics-driven pricing pressures, positioning D07AB agents as mid-tier options in dermatology’s potency spectrum[4][5].

References

1. https://en.wikipedia.org/wiki/ATC_code_D07
2. https://core.ac.uk/download/pdf/161377882.pdf
3. https://pubchem.ncbi.nlm.nih.gov/patent/US-10112970-B2
4. https://pmc.ncbi.nlm.nih.gov/articles/PMC8916090/
5. https://atcddd.fhi.no/atc_ddd_index/?code=D07AB&showdescription=yes
6. https://atcddd.fhi.no/atc_ddd_index/?code=D07A
7. https://catalogues.ema.europa.eu/sites/default/files/document_files/B026%20PASS_Redacted%20(1).pdf
8. https://www.drugpatentwatch.com/p/generic/desonide
9. https://go.drugbank.com/drugs/DB00620
10. https://www.databridgemarketresearch.com/reports/global-topical-corticosteroids-market
11. https://www.ophthalmologytimes.com/view/patents-granted-for-combination-antibiotics-with-steroids-as-topical-eye-drops
12. https://www.medrxiv.org/content/10.1101/2024.08.12.24311869v1.full-text
13. https://patents.google.com/patent/US8809307B2/en