Sulfonylurea Drug Class List

Drugs in Drug Class: Sulfonylurea

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Micro Labs	GLIMEPIRIDE	glimepiride	TABLET;ORAL	091220-005	Jun 29, 2012		RX	No	No
Prinston Inc	GLIMEPIRIDE	glimepiride	TABLET;ORAL	077370-003	Dec 23, 2005	AB	RX	No	No
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	AB	RX	Yes	Yes	8,071,130		Y
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-001	Jul 28, 2006	AB	RX	Yes	Yes	7,700,128		Y
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	AB	RX	Yes	No	8,071,130		Y
Takeda Pharms Usa	DUETACT	glimepiride; pioglitazone hydrochloride	TABLET;ORAL	021925-002	Jul 28, 2006	AB	RX	Yes	No	7,700,128		Y

Sulfonylurea Market Analysis and Financial Projection

The sulfonylurea drug class, a cornerstone in type 2 diabetes management, faces evolving market dynamics shaped by clinical demand, patent expirations, and competitive pressures from newer therapies. Below is a detailed analysis:

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Market Dynamics of Sulfonylureas

Current Valuation and Growth Trends
The global sulfonylureas market was valued at USD 7.25 billion in 2024, with projections reaching USD 9.32 billion by 2032 at a 3.19% CAGR [1]. Alternate estimates suggest a higher trajectory, targeting USD 12 billion by 2030 [4]. Growth is driven by:

• Rising Diabetes Prevalence: Over 537 million adults had diabetes in 2021, expected to rise to 643 million by 2030 [4].
• Cost-Effectiveness: Sulfonylureas remain 30–50% cheaper than newer agents like GLP-1 agonists, favoring adoption in low/middle-income countries [6].
• Aging Populations: Increased type 2 diabetes incidence in older demographics [10].

Regional Breakdown

Region	Market Share (2024)	Key Growth Drivers
North America	~35%	High healthcare spending, obesity rates (~42% U.S. adults) [10].
Asia-Pacific	~28%	Urbanization, sedentary lifestyles, and rising diabetic populations in India/China [3][8].
Europe	~22%	Robust generics market and aging demographics [3].

Competitive Challenges

• Newer Drug Classes: GLP-1 agonists (e.g., semaglutide) and SGLT2 inhibitors (e.g., empagliflozin) offer cardiovascular/renal benefits, capturing ~40% of new prescriptions [6].
• Side Effects: Hypoglycemia risk and weight gain (4–5 kg average) limit sulfonylurea appeal [4].

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Patent Landscape and Strategic Shifts

Historical Innovations

• Core Patents: The foundational sulfonylurea patent (US3157700A) dates to 1961, covering phenyl-substituted derivatives [2].
• Extended-Release Formulations: Patents like US6056977A (1999) for once-daily glipizide formulations sought to improve compliance [9].
• Combination Therapies: US5859037 (1999) combined sulfonylureas with glitazones (e.g., pioglitazone) to enhance efficacy [12].

Recent Expirations and Generics Impact	Patent Holder	Drug	Key Expiring Patents (2024–2028)	Impact
Sanofi	Insulin Glulisine	US9011391, US9827379 (2024)	Opens door for biosimilars in North America/Europe [5][7].
AstraZeneca	Exenatide	US8329648, US8906851 (2026)	Accelerates competition in GLP-1/Sulfonylurea combo markets [5][13].

Strategic Patent Trends

• Device-Dependent Patents: ~63% of insulin delivery system patents focus on injection devices (e.g., pens) rather than active ingredients [7].
• Post-Approval Filings: Companies like AstraZeneca extend protection by 6 years on average via post-approval patents [7][13].

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Future Outlook

• Generics Dominance: Expired patents will reduce branded sulfonylurea prices by 15–20% by 2030, improving accessibility [5][6].
• Regional Expansion: Asia-Pacific to grow at 4.1% CAGR, driven by India’s generic production and China’s diabetes surge [3][8].
• Personalized Medicine: Genetic testing (e.g., CYP2C9 variants) may refine sulfonylurea dosing, mitigating side effects [6].

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Key Market Players

• Brand Leaders: AstraZeneca, Sanofi, Novartis [1].
• Generics Manufacturers: Sun Pharma, Teva, Dr. Reddy’s [1][4].

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"The global diabetes epidemic demands innovative yet affordable therapies. Sulfonylureas’ cost-effectiveness ensures their relevance, despite newer entrants." – Mordor Intelligence Analysis [4].

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Sulfonylureas remain vital in diabetes care, particularly in resource-limited settings. However, their market longevity hinges on strategic pricing, combination therapies, and navigating patent cliffs amid intensifying competition.

References

1. https://www.databridgemarketresearch.com/reports/global-sulfonylureas-market
2. https://patents.google.com/patent/US3157700A/en
3. https://www.reanin.com/reports/global-sulfonylureas-market
4. https://www.mordorintelligence.com/industry-reports/sulfonylureas-market
5. https://www.greyb.com/blog/diabetes-drug-patents-expiring/
6. https://markwideresearch.com/sulfonylureas-market/
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC10653475/
8. https://www.qyresearch.com/reports/2580585/sulfonylurea-herbicide
9. https://patents.google.com/patent/US6056977A/en
10. https://www.globenewswire.com/news-release/2024/01/31/2820641/0/en/North-America-Sulfonylureas-Market-Projected-to-Grow-Hitting-USD-3-35-Billion-Valuation-by-2028-with-Notable-CAGR-of-1-90.html
11. https://www.epo.org/en/boards-of-appeal/decisions/t120045eu1
12. https://www.drugpatentwatch.com/p/patent/5859037
13. https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2023/pdf/AstraZeneca_Patent_Expiries_of_Key_Marketed_Products_2023.pdf
14. https://www.ipcheckups.com/patent-landscape-analysis-overview/
15. https://caldwelllaw.com/news/how-patent-landscape-analysis-drives-business-growth/
16. https://www.dilworthip.com/resources/news/patent-landscape-analysis/