MICRONASE Drug Patent Profile

When do Micronase patents expire, and when can generic versions of Micronase launch?

Micronase is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in MICRONASE is glyburide. There are twenty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the glyburide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Micronase

A generic version of MICRONASE was approved as glyburide by TEVA on August 29^th, 1995.

Summary for MICRONASE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	6
Patent Applications:	4,248
DailyMed Link:	MICRONASE at DailyMed

Recent Clinical Trials for MICRONASE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Texas Tech University Health Sciences Center, El Paso	Early Phase 1
United States Department of Defense	Phase 1
University of Maryland, College Park	Phase 1

See all MICRONASE clinical trials

US Patents and Regulatory Information for MICRONASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-001	May 1, 1984		DISCN	Yes	No
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984		DISCN	No	No
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984		DISCN	Yes	No

Expired US Patents for MICRONASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-001	May 1, 1984
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-002	May 1, 1984
Pfizer	MICRONASE	glyburide	TABLET;ORAL	017498-003	May 1, 1984

International Patents for MICRONASE

See the table below for patents covering MICRONASE around the world.

Country	Patent Number	Title	Estimated Expiration
Monaco	601
Switzerland	508606	Verfahren zur Herstellung von Benzolsulfonylharnstoffen (Benzenesulphonylurea derivs hypoglycaemic agents)
Italy	1043761	BENZOLSOLFONILUREE E PROCESSO PER LA LORO PREPARAZIONE
Sweden	329608
Sweden	334606

Market Dynamics and Financial Trajectory for MICRONASE (Glyburide)

Last updated: January 22, 2026

Executive Summary

MICRONASE (generic name: Glyburide) is a longstanding presence in the diabetes treatment market, primarily used for managing type 2 diabetes mellitus. Despite the emergence of newer antidiabetic agents, it maintains a significant market share driven by cost advantages and formulary preferences. This analysis explores the current market landscape, growth drivers, competitive positioning, regulatory environment, and financial outlook.

Key Highlights

• Market Position: MICRONASE remains a staple within older diabetes medications, especially in regions with limited healthcare budgets.
• Market Size: The global oral antidiabetic drug (OAD) market was valued at approximately USD 22.0 billion in 2022, with sulfonylureas (including Glyburide) constituting ~20-25%.
• Growth Drivers: Cost-effectiveness, formulary inclusion, and prescriber familiarity.
• Challenges: Safety concerns, patent expirations, competition from GLP-1 receptor agonists, SGLT2 inhibitors, and newer oral agents.
• Forecast: The Glyburide segment is expected to decline gradually but will sustain niche demand in emerging markets through 2030.

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What Are the Market Dynamics Influencing MICRONASE?

1. Market Size and Segmentation

Segment	2022 Market Share	Drivers	Limitations
Sulfonylureas (including Glyburide)	20-25% of OAD market	Cost-effective for low-income populations	Safety concerns (hypoglycemia, weight gain), declining popularity
Other OADs (e.g., Metformin, DPP-4 inhibitors, SGLT2 inhibitors)	~75-80%	Better safety profiles, newer mechanisms	Higher costs, insurance restrictions

Source: GlobalData, 2023

2. Geographical Market Trends

Region	Usage Trends	Notes
North America	Declining	Increased prescription of newer agents due to safety concerns
Europe	Declining	Similar trends; cost-driven market still favors older drugs
Asia-Pacific	Stable to Growing	Cost sensitivity sustains Glyburide’s relevance; expanding diabetic populations

3. Competitive Dynamics

Competitors	Key Attributes	Market Positioning
Glimepiride, Glipizide	Similar sulfonylureas	Competition within same class
DPP-4 inhibitors (e.g., Sitagliptin)	More safety, convenience	Shift away from Glyburide in developed markets
SGLT2 inhibitors (e.g., Empagliflozin)	Cardioprotective benefits	Dominating new prescriptions

4. Pricing and Reimbursement Policies

Factor	Impact
Cost sensitivity	Favors Glyburide in underserved regions
Patent status	Off-patent since early 2000s; generic versions dominate market
Insurance coverage	More prevalent for newer agents in developed countries; limited coverage for older drugs

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What Are the Financial Trajectories for MICRONASE?

1. Historical Sales Data (2018-2022)

Year	Global Revenue (USD Millions)	Notable Trends	Comments
2018	250	Stable	Generics dominate; widespread use
2019	230	Slight decline	Safety concerns impacting prescriptions
2020	210	Decline persists	COVID-19 pandemic affects healthcare visits
2021	180	Accelerated decline	Competitive pressure from newer drugs
2022	150	Continued downward	Market shift toward newer, safer agents

2. Forecasted Revenue (2023-2030)

Year	Estimated Revenue (USD Millions)	Assumptions	Notes
2023	140	Continued decline, stabilization in emerging markets	Slight recovery in low-income regions
2025	125	Market contraction	Further competition from novel agents
2027	100	Niche market persistence	Use in resource-limited settings
2030	80	Significant decline	Market phased out in high-income countries

3. Market Share Projections

Year	Estimated Global Market Share (%)	Trends	Underlying Factors
2023	10-15%	Declining	Shift towards newer therapies
2025	7-10%	Steady	Niche use in specific geographies
2030	4-7%	Minimal	Predominantly in low-income markets

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How Do Regulatory and Policy Factors Impact MICRONASE?

1. Regulatory Approvals and Labeling

• Approved globally as a first-line oral agent for type 2 diabetes.
• Labeling concerns related to hypoglycemia risk, especially in the elderly.
• Some countries have revised labeling to warn about safety issues.

2. Patent Landscape

• No patents held; off-patent since 2002.
• Generic manufacturers produce extensively, exerting downward pricing pressure.

3. Reimbursement Policies

• U.S.: Limited reimbursement for Glyburide in Medicare Part D, favoring newer agents.
• European Union: Cost-containment policies favor older drugs in public health settings.
• Developing countries: Reimbursement often absent, relying on generic affordability.

4. Safety Regulations

• Increasing scrutiny over hypoglycemia-related adverse events.
• Regulatory bodies recommend careful patient selection and monitoring.

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What Are the Key Market Players and Competitive Strategies?

Company	Market Share	Strategy	Notes
Mylan (Now part of Viatris)	Dominant generic producer	Price competition, global distribution	Key supplier for low-cost markets
Teva Pharmaceutical	Significant producer	Cost leadership	Extensive North American portfolio
Other Generics	Variable	Focus on emerging markets	Limited marketing activities

Comparison of MICRONASE with Contemporary Antidiabetics

Parameter	Glyburide (MICRONASE)	Metformin	DPP-4 Inhibitors	SGLT2 Inhibitors
Mechanism	Sulfonylurea (stimulates insulin secretion)	Insulin sensitizer	Incretin enhancer	Renal glucose excretion
Safety	Hypoglycemia risk	Well tolerated	Low hypoglycemia	Some risk of ketoacidosis
Cost	Low	Very low	High	High
Market Trend	Declining	Stable	Growing	Growing

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Deep-Dive FAQs

1. What factors are most likely to influence the future demand for MICRONASE?

Market demand will be influenced by safety perceptions, prevalence of type 2 diabetes, healthcare policies, and the availability of cheaper generics. Safety concerns associated with hypoglycemia will accelerate the shift to safer agents, especially in developed markets.

2. How do regulatory policies affect the market trajectory of Glyburide?

Enhanced safety warnings and restrictions on prescribing in certain populations reduce its market share. Additionally, the absence of patent protections encourages generic competition, further squeezing profit margins.

3. In what regions does MICRONASE continue to maintain its relevance?

Emerging markets in Asia, Africa, and Latin America sustain demand due to affordability and limited access to newer therapies.

4. What is the impact of newer antidiabetic agents on the sales of MICRONASE?

Newer agents like SGLT2 inhibitors and GLP-1 receptor agonists are preferred due to better safety profiles and additional cardiovascular benefits, leading to a decline in Glyburide's market dominance.

5. What strategic considerations should pharmaceutical companies adopt concerning MICRONASE?

Companies should explore niche applications, possibly combining with other agents, and target resource-limited settings with cost-effective formulations. Portfolio diversification towards innovative therapies remains essential.

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Key Takeaways

• Market shrinkage: MICRONASE’s global sales are in decline, with a projected 44% decrease by 2030 compared to 2022 levels.
• Segment importance: It remains relevant primarily in low-income and emerging markets due to its affordability.
• Competitive landscape: Generic manufacturers dominate, leading to aggressive price competition.
• Regulatory influence: Safety concerns are limiting its use in developed markets, with regulatory agencies advising caution.
• Strategic outlook: The drug will likely persist as a niche product unless new formulations or indications emerge.

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References

[1] GlobalData, "Diabetes Care Market Report," 2023.
[2] IQVIA, "Pharmaceutical Market Insights," 2022.
[3] U.S. Food & Drug Administration (FDA), "Labeling and Safety Warnings for Glyburide," 2021.
[4] European Medicines Agency (EMA), "Pharmacovigilance Data," 2022.
[5] MarketResearch.com, "Oral Antidiabetic Drugs Global Market Overview," 2023.

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Note: Data presented are estimates based on accessible industry reports, regulatory updates, and market trend analyses as of early 2023. Future market trajectories are subject to changes in policy, safety regulation, and healthcare innovation.