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Drugs in ATC Class M01AB
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Drugs in ATC Class: M01AB - Acetic acid derivatives and related substances
| Tradename | Generic Name |
|---|---|
| CLINORIL | sulindac |
| SULINDAC | sulindac |
| TOLECTIN DS | tolmetin sodium |
| TOLMETIN SODIUM | tolmetin sodium |
| >Tradename | >Generic Name |
Showing 1 to 4 of 4 entries
M01AB Market Analysis and Financial Projection
The ATC class M01AB, encompassing acetic acid derivative NSAIDs like diclofenac, ketorolac, and indometacin, exhibits dynamic market trends shaped by regional utilization patterns, patent strategies, and evolving regulatory landscapes. These drugs, primarily used for pain and inflammatory conditions, face competition from generics while innovation in formulations drives niche opportunities.
Market Dynamics
- Regional Utilization Differences: Serbia’s median expenditure on M01AB drugs (€10.3M, 2010–2015) significantly outpaced Croatia’s (€4.7M), reflecting divergences in prescribing practices or healthcare policies[1].
- External Demand Influences: Sales of M01AB drugs show sensitivity to atmospheric pressure changes, suggesting weather-related pain fluctuations may impact consumption patterns[6].
- Growth Drivers: The global acetic acid market, a precursor for some M01AB drugs, is projected to grow at 5.1% CAGR (2018–2023), potentially influencing raw material costs and supply stability[16].
Patent Landscape
- Key Drug Patents:
- Diclofenac: Holds 48 active patents, with recent innovations like Lincoln Pharmaceuticals’ rectal spray (IN320894, valid until 2039)[12][15].
- Ketorolac: Supported by 23 patents, reflecting sustained R&D investment[3].
- Etodolac: No active patents, indicating full genericization[8].
- USPTO Policy Shifts: The 2025 leadership transition at the USPTO prioritizes patent-owner-friendly policies, though operational hurdles like examiner shortages may prolong application backlogs (currently 26.2 months average pendency)[14].
- Emerging Technologies: Patent filings for acetic acid production methods declined 2016–2020, with methanol carbonylation remaining dominant (62% of patents) and fermentation methods attracting interest for sustainability[2][7].
Competitive Forces
- Generic Penetration: Drugs like etodolac face stiff generic competition, while diclofenac’s novel delivery systems (e.g., metered-dose sprays) carve branded niches[12][15].
- Strategic Portfolio Management: Companies leverage patent landscaping to identify white spaces and monitor competitors. For example, 2,895 patent families in bispecific antibodies highlight cross-industry innovation spillovers[10][17].
Regulatory and Economic Factors
- Pricing Power: Drugs with inelastic demand (e.g., essential NSAIDs) retain pricing flexibility despite competition, contrasting with elastic markets like luxury goods[9].
- Fee Structures: The USPTO’s 2025 fee adjustments target older filings, potentially discouraging prolonged patent extensions and accelerating generics entry[14].
Future Outlook
The M01AB market will likely balance cost pressures from generics against opportunities in advanced formulations and geographic expansion. Companies investing in patient-centric delivery systems (e.g., Lincoln’s spray) or targeting underserved regions may offset revenue losses from patent cliffs. Meanwhile, regulatory agility and AI-driven patent analytics[14][17] will be critical for navigating the evolving IP landscape.
“Globally, no liquid formulation of diclofenac for rectal administration is available. This innovation offers better compliance and rapid drug release.” — Mahendra Patel, Lincoln Pharma[12]
References
- https://pmc.ncbi.nlm.nih.gov/articles/PMC6070606/
- https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID4198207_code2688756.pdf?abstractid=3928478&mirid=1
- https://go.drugbank.com/drugs/DB00465
- https://atcddd.fhi.no/atc_ddd_index/?showdescription=yes&code=M01AB
- https://www.atccode.com/M01AB
- https://www.eventiotic.com/eventiotic/files/Papers/URL/ecd717ff-6839-4b01-a64f-d05f52721de1.pdf
- https://www.ssrn.com/abstract=3928478
- https://go.drugbank.com/drugs/DB00749
- https://www.investopedia.com/terms/m/market-dynamics.asp
- https://www.knowmade.com/wp-content/uploads/2025/01/Bispecific-Ab-Patent-Landscape-2025-FLYER.pdf
- https://www.bccresearch.com/market-research/biotechnology/antibody-drugs-technologies-global-markets-report.html
- https://www.pharmtech.com/view/lincoln-pharmaceuticals-receives-patent-novel-diclofenac-solution
- https://marketdynamics.com
- https://www.morganlewis.com/pubs/2025/03/uspto-in-2025-leadership-operational-legislative-and-policy-changes-to-watch
- https://go.drugbank.com/drugs/DB00586
- https://www.bccresearch.com/market-research/chemicals/acetic-acid-derivatives-and-global-markets.html
- https://patentskart.com/technology-landscape/
- https://www.pharmamanufacturing.com/home/article/55249347/key-drugs-losing-patent-protection-in-2025
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