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Drugs in ATC Class A10BB
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Drugs in ATC Class: A10BB - Sulfonylureas
| Tradename | Generic Name |
|---|---|
| CHLORPROPAMIDE | chlorpropamide |
| DIABINESE | chlorpropamide |
| GLUCAMIDE | chlorpropamide |
| >Tradename | >Generic Name |
Showing 1 to 3 of 3 entries
A10BB Market Analysis and Financial Projection
The sulfonylureas market (ATC Class A10BB) demonstrates steady growth driven by rising diabetes prevalence, while facing headwinds from patent expirations and generic competition. Here's an analysis of the market dynamics and intellectual property landscape:
Market Dynamics
Current Valuation & Projections
- Valued at $7.25B in 2024, the market is projected to reach $9.32B by 2032 (3.19% CAGR)[1][6]. Alternative estimates suggest a higher trajectory, reaching $12B by 2030[6].
- Key growth drivers:
- 537M global diabetes cases (2021), expected to rise to 643M by 2030[6]
- Obesity-linked Type 2 diabetes accounting for 90-95% of cases[1][6]
- Initiatives like WHO's Global Diabetes Compact improving treatment access[6]
Regional Trends
- North America dominates with >40% market share due to high obesity rates and advanced healthcare[6]
- Middle East & Africa show highest growth (15% CAGR) driven by:
- 73M diabetes cases in MENA region (2021)[6]
- Saudi Arabia's healthcare reforms and insurance expansion[6]
| Competitive Landscape | Key Players | Strategic Focus |
|---|---|---|
| Sanofi, Pfizer, Merck | Patent-protected brands (e.g., Amaryl)[5] | |
| Dr. Reddy's, Sun Pharma, Lupin | Generic production post-patent expiry[1][5] | |
| AstraZeneca, Novartis | R&D for combination therapies[8] |
Challenges
- Generic erosion from expired patents (e.g., glimepiride generics approved in 2/4/8mg doses)[5]
- Contraindications for patients with renal/hepatic impairment or sulfa allergies[1]
- Side effects: hypoglycemia (4.9% incidence), weight gain, GI disturbances[1][6]
Patent Landscape
Key Therapeutic Patents
- WO2016131098A1: Covers novel sulfonylurea derivatives with improved stability (2016 priority date)[2]
- US3157700A: Fundamental patent for para-nitrophenyl sulfonylureas (expired)[3]
- EP2800811: Protects combination therapies with insulin sensitizers like pioglitazone[8]
| Generic Competition Timeline | Drug | Patent Expiry | Generic Status |
|---|---|---|---|
| Glimepiride | 2025 (US)[5] | Tentative approvals for 2/4/8mg tablets[5] | |
| Glyburide | Expired | 15+ generic versions available[16] |
Strategic IP Developments
- Combination Therapies: Patent disputes over metformin-sulfonylurea combinations (e.g., PTAB rulings on pioglitazone-glimepiride synergy)[8]
- Formulation Patents: Extended-release technologies (e.g., polymer-based delivery systems) facing challenges from ANDA filings[10][14]
- Regional Variations:
- European revocations of Broad Institute's diabetes patents[9]
- India's Section 3(d) preventing evergreening of minor modifications[1]
Future Outlook
- R&D Opportunities: 83 clinical trials active for sulfonylureas, focusing on cardiovascular outcomes and combo therapies[5][8]
- Market Threats: SGLT2 inhibitors and GLP-1 agonists capturing 38% of new prescriptions[12]
- Generic Impact: Post-2025 patent cliffs may reduce brand prices by 60-80% while expanding access[10][14]
"The advent of new diabetic monitoring systems could revitalize sulfonylurea use through precision dosing, mitigating hypoglycemia risks."[1]
This evolving landscape positions sulfonylureas as cost-effective options in LMICs, while innovation focuses on reducing adverse effects through pharmacokinetic optimization and digital health integration[6][15].
References
- https://www.databridgemarketresearch.com/reports/global-sulfonylureas-market
- https://patents.google.com/patent/WO2016131098A1/en
- https://patents.google.com/patent/US3157700A/en
- https://www.intellectualmarketinsights.com/report/sulfonylureas-market-research-current-trends-and-growth/imi-005681
- https://www.drugpatentwatch.com/p/generic/glimepiride
- https://www.mordorintelligence.com/industry-reports/sulfonylureas-market
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11207096/
- https://www.epo.org/en/boards-of-appeal/decisions/t120045eu1
- https://ersgenomics.com/wp-content/uploads/2023/05/LSPN-Deck-043023.pdf
- https://www.drugs.com/availability/generic-bydureon-bcise.html
- https://patentpc.com/blog/assess-the-market-viability-of-your-patent
- https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/mir-antidiabetic-drugs-2012-2021.html
- https://www.fbrice.com.au/ip-news-insights/traversing-a-dynamic-adc-patent-landscape-2/
- https://www.drugs.com/availability/generic-bydureon.html
- https://patentpc.com/blog/the-role-of-market-analysis-in-patent-valuation/
- https://www.databridgemarketresearch.com/reports/global-sulfonylureas-market/market-analysis
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