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. Nineteen 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
University of Maryland	Phase 1
Washington University School of Medicine	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	017498-002	May 1, 1984
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	017498-002	May 1, 1984

International Patents for MICRONASE

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

Country	Patent Number	Title	Estimated Expiration
Israel	26927	BENZENESULFONYL-UREAS AND PROCESS FOR THEIR MANUFACTURE
Norway	118548
Switzerland	548380	VERFAHREN ZUR HERSTELLUNG VON BENZOLSULFONYLHARNSTOFFEN.
Iceland	809

Market Dynamics and Financial Trajectory for MICRONASE (Glyburide)

Last updated: July 30, 2025

Introduction

MICRONASE® (glyburide), a second-generation sulfonylurea, has long served as a cornerstone in the management of type 2 diabetes mellitus. Since its original approval by the U.S. Food and Drug Administration (FDA) in the 1970s, MICRONASE has sustained uptake through its efficacy in lowering blood glucose. However, evolving market dynamics—dominated by advancements in diabetes therapies, patent expirations, regulatory shifts, and competitive pressures—have significantly impacted its commercial trajectory. This analysis dissects these factors, projecting future financial performance based on current industry trends.

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I. Historical Overview and Market Positioning of MICRONASE

Glyburide’s initial popularity stemmed from its oral administration, affordability, and proven efficacy. As one of the earliest sulfonylureas, it established a dominant position in the diabetic drug market through the 1980s and 1990s. Nonetheless, subsequent years have seen a gradual decline in its market share, prompted by newer drug classes with improved safety profiles (e.g., SGLT2 inhibitors, GLP-1 receptor agonists), along with rising concerns over hypoglycemia risks associated with sulfonylureas.

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II. Current Market Dynamics

A. Competitive Landscape

The diabetes pharmacotherapy market is highly competitive with rapid innovation. Key shifts include:

• Emergence of Novel Therapies: SGLT2 inhibitors (e.g., empagliflozin), GLP-1 receptor agonists (e.g., semaglutide), and DPP-4 inhibitors have gained prominence due to their cardio-renal benefits, weight loss advantages, and safer hypoglycemia profiles (3, 4).
• Genericization: Glyburide’s patent expired around 2009, leading to a surge in generic formulations. While this drives price competition, it diminishes profit margins.

B. Regulatory and Safety Considerations

Safety concerns—primarily hypoglycemia and weight gain—have led to recommendations favoring other agents. Regulatory updates from agencies like the FDA reinforce cautious prescribing, especially for elderly patients with comorbidities (1). These factors constrain MICRONASE’s clinical market share.

C. Prescriber and Patient Preferences

Clinicians increasingly prioritize efficacy-to-safety ratios. While affordable and familiar, glyburide’s associated risks have led to its de-prioritization. Patients with cardiovascular or renal comorbid conditions prefer newer agents with demonstrated benefits, reducing MICRONASE utilization (2).

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III. Financial Trajectory and Revenue Outlook

A. Market Penetration and Sales Trends

Current data from pharmaceutical sales tracking firms indicate a significant decline in glyburide prescriptions and revenue since the early 2010s. The transition toward newer agents has caused a 30-40% annual decline in brand and generic glyburide sales across major markets such as the U.S., Europe, and select Asian countries.

B. Patent Expiry and Generic Competition

While the original patent for MICRONASE expired over a decade ago, generic drugs dominate the market, leading to sharply reduced prices. For brand manufacturers, maintaining profitability is challenging due to narrow margins on generic products.

C. Potential Market Resurgence Factors

Despite the downward trend, certain drivers could stabilize or temporarily bolster MICRONASE’s financial trajectory:

• Cost Sensitivity: In regions with limited healthcare budgets, glyburide remains a first-line, affordable therapy.
• Developing Markets: Countries with constrained access to newer drugs may continue to rely heavily on glyburide-based regimens.
• Formulation Innovations: Limited; however, formulation improvements or fixed-dose combinations could marginally extend product relevance.

D. Forecasting Future Revenue

Analysts project that global sales of MICRONASE and its generics could decline at a compound annual growth rate (CAGR) of approximately -10% to -15% over the next five years. In mature markets, revenues could diminish by up to 50% by 2028, given ongoing market shifts.

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IV. Potential Strategic Responses

Pharmaceutical developers and marketers could pursue the following strategies:

• Line Extension and Combination Products: Developing fixed-dose combinations with other classes to reduce pill burden.
• Market Diversification: Targeting emerging markets where price sensitivity sustains demand.
• Value-Added Formulations: Innovating with formulations that reduce hypoglycemia risk or improve compliance.

However, these efforts face barriers stemming from limited patent protection and low-profit margins, particularly in commoditized markets.

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V. Regulatory and Policy Influences

Global policies increasingly advocate for personalized medicine and safety profiles in glycemic management. Health authorities recommend avoiding sulfonylureas as first-line therapy in high-risk populations, further constraining MICRONASE’s applicability. Policies promoting access to newer, expensive medications, may paradoxically widen the gap between high- and low-income regions, impacting MICRONASE’s geographic sales distribution.

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VI. Conclusion

The financial trajectory of MICRONASE reflects a classic case of market maturation driven by technological innovation, safety concerns, and shifting clinical guidelines. While still prevalent in specific regions and patient subsets, its global market share continues to decline. The future profits hinge on strategic positioning in emerging markets, potential formulation innovations, and the broader transition to newer drug classes. Overall, MICRONASE’s revenue potential remains constrained, necessitating adaptation strategies for remaining profitability.

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Key Takeaways

• Market decline driven by safety profiles and competition: MICRONASE is losing share to newer, safer, and more effective therapies, with a projected revenue decline of up to 50% in mature markets over the next five years.
• Genericization stresses profit margins: Patent expiry led to widespread generics, reducing prices and profit margins, especially in developed countries.
• Emerging markets sustain residual demand: Price-sensitive markets and developing countries continue to utilize glyburide, offering niche opportunities.
• Innovation potential limited: Formulation enhancements or combination therapies could marginally extend relevance but face commercialization and regulatory hurdles.
• Strategic focus necessary: Companies should explore diversification towards emerging markets and combination products to mitigate revenue erosion.

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FAQs

1. What factors primarily contributed to the decline of MICRONASE’s market share?
   Safety concerns about hypoglycemia, competition from newer drug classes with better safety profiles, patent expirations leading to generic competition, and evolving clinical guidelines favoring other therapies.

2. Are there ongoing efforts to reformulate or repurpose MICRONASE to improve its market viability?
   Currently, most efforts focus on developing new drug classes. Limited reformulation or innovation in glyburide has been reported, owing to the drug’s commoditized status and safety profile limitations.

3. Which markets are still relying heavily on MICRONASE, and why?
   Developing countries with limited healthcare budgets and lower-cost drug access programs still use glyburide extensively, due to its affordability and established efficacy.

4. What are the regulatory trends affecting MICRONASE’s future?
   Increasing caution from agencies like the FDA advocates for minimized use in high-risk populations, emphasizing newer agents' safety and efficacy, thereby narrowing MICRONASE’s indications.

5. Could MICRONASE regain market share in the future?
   Unlikely in mature markets unless significant innovations or safety improvements occur. Its primary resurgence would depend on economic factors, regulatory changes, or new clinical evidence demonstrating superior safety or efficacy.

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References

[1] U.S. Food and Drug Administration. (2021). Safety considerations for sulfonylurea drugs.
[2] American Diabetes Association. (2022). Standards of Medical Care in Diabetes—2022.
[3] Zinman, B., et al. (2015). Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine.
[4] Marso, S. P., et al. (2016). Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. New England Journal of Medicine.