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Drugs in ATC Class N04BA
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Drugs in ATC Class: N04BA - Dopa and dopa derivatives
| Tradename | Generic Name |
|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa |
| STALEVO 100 | carbidopa; entacapone; levodopa |
| STALEVO 125 | carbidopa; entacapone; levodopa |
| STALEVO 150 | carbidopa; entacapone; levodopa |
| >Tradename | >Generic Name |
N04BA Market Analysis and Financial Projection
The market dynamics and patent landscape for ATC Class N04BA (Dopa and dopa derivatives) reflect a sector driven by innovation in Parkinson’s disease treatment, competitive pressures from generics, and strategic patent management. Below is a detailed breakdown:
Market Dynamics
Growing Demand in Parkinson’s Disease
The global Parkinson’s disease drug market was valued at $3.4 billion in 2023 and is projected to reach $7.9 billion by 2033 (CAGR: 8.9%)[4]. The U.S. dominates with 63.3% market share, driven by high treatment costs and a large patient population[4]. Levodopa, the cornerstone therapy, accounts for a $1.7 billion market (2022) expected to grow to $2.9 billion by 2032 (CAGR: 6.1%)[17]. Key growth drivers include:
- Aging populations and rising Parkinson’s prevalence[17].
- Demand for sustained-release formulations to reduce dosing frequency[11][16].
Segmentation and Distribution
- Formulation: Tablets dominate (convenience, affordability), followed by capsules and liquid forms[17].
- Route of Administration: Oral delivery leads (93% market share), preferred for ease[17].
- Distribution: Retail pharmacies account for 50% of sales, with online channels growing[17].
Competitive Landscape
- Generic Dominance: Levodopa/carbidopa combinations are widely genericized, reducing costs but limiting differentiation[6].
- Innovative Therapies: New formulations like IPX203 (extended-release carbidopa/levodopa) and foscarbidopa/foslevodopa (AbbVie’s subcutaneous infusion) aim to extend market exclusivity[11][19].
Patent Landscape
Key Trends
- Patent Cliffs: Major drugs (e.g., levodopa/carbidopa) face generic competition, but reformulations and combinations drive new patents (e.g., Stalevo)[9].
- Strategic Filings: Companies focus on:
- Delivery Systems: Proprietary technologies like Intec Pharma’s Accordion Pill™ (patented until 2031)[16].
- Combination Therapies: Additions of COMT inhibitors (e.g., entacapone) to improve efficacy[1][9].
- Geographic Focus: 60% of patents originate in the U.S., with secondary filings in Japan and Europe[6].
Notable Patents
| Patent/Product | Key Innovation | Expiry | Company |
|---|---|---|---|
| US-10624839-B2[5] | Low-impurity carbidopa formulations | 2040 | NeuroDerm |
| IPX203[11] | Extended-release carbidopa/levodopa | 2030s | Amneal |
| Accordion Pill™[16] | Gastric retention for steady absorption | 2031 | Intec Pharma |
| Foslevodopa[19] | Continuous subcutaneous infusion | 2039 | AbbVie |
Challenges
- R&D Slowdown: Parkinson’s drug patents peaked in 2017, reflecting barriers to novel targets[6].
- Litigation Risks: Disputes over terms like “stable dose of levodopa” highlight the importance of precise patent claims[18].
Strategic Insights
- White Spaces: Opportunities exist in non-oral delivery (e.g., subcutaneous infusions) and digital therapeutics[19].
- Collaborations: Partnerships between generics manufacturers and innovators to co-develop formulations (e.g., NeuroDerm’s licensing deals)[5].
- Regulatory Shifts: Pro-crypto policies under recent U.S. administrations may accelerate blockchain use in IP management[2].
Future Outlook
While generics will pressure pricing, the market will grow through niche formulations (e.g., hourly expirations, event-specific dosing) and personalized therapies. Patent landscape analysis remains critical to navigate crowded fields and identify adjacencies (e.g., gene therapy patents)[10][15].
“Derivatives are used to hedge and profit in nearly every global market, and those markets most impacted by the world’s unknowns are likely to benefit the most.” [2]
References
- https://atcddd.fhi.no/atc_ddd_index/?code=N04BA
- https://www.greenwich.com/market-structure-technology/drivers-derivatives-markets-growth-year-ahead
- https://patentpc.com/blog/assess-the-market-viability-of-your-patent
- https://www.globenewswire.com/news-release/2025/03/05/3037571/28124/en/7MM-7-9-Bn-Parkinson-s-Disease-Market-Drug-Forecast-and-Market-Analysis-2023-2025-2033-Novel-Symptomatic-treatments-will-continue-to-shape-the-PD-market.html
- https://pubchem.ncbi.nlm.nih.gov/patent/US-10624839-B2
- https://www.maxval.com/blog/pharma-patent-landscape-parkinsons-disease-uncovered/
- https://go.drugbank.com/drugs/DB01235
- https://www.elibrary.imf.org/display/book/9781589062917/ch04.xml
- https://www.drugpatentwatch.com/p/atc-class/N04BA
- https://caldwelllaw.com/news/how-patent-landscape-analysis-drives-business-growth/
- https://investors.amneal.com/news/press-releases/press-release-details/2018/Amneal-Announces-Issuance-of-New-Patent-for-IPX203-an-Investigational-Extended-Release-Formulation-of-Carbidopa-Levodopa/default.aspx
- https://www.globenewswire.com/news-release/2025/02/06/3021838/28124/en/Blood-Plasma-Derivatives-Market-Insights-and-Forecast-2025-2030-Grifols-SK-Plasma-and-Fusion-Health-Care-Lead-the-Competition.html
- https://vvkt.lrv.lt/media/viesa/saugykla/2023/9/nvNsI8S7K9U.pdf
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10663041/
- https://www.ipcheckups.com/patent-landscape-analysis-overview/
- https://www.biospace.com/intec-pharma-granted-u-s-patent-for-accordion-pill-comprising-levodopa-for-improved-treatment-of-parkinson-s-diseases-symptoms
- https://www.alliedmarketresearch.com/levodopa-market-A213646
- https://www.finnegan.com/en/insights/blogs/prosecution-first/intrinsic-evidence-decodes-disputed-claim-terms.html
- https://clarivate.com/drugs-to-watch/drugs-to-watch-listing/foscarbidopa-foslevodopa/
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