MICRONASE Drug Patent Profile

When do Micronase patents expire, and what generic alternatives are available?

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

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

International Patents for MICRONASE

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	478104	Verfahren zur Herstellung von Benzolsulfonylharnstoffen
Iceland	1424
Sweden	329608
Spain	344046
Monaco	601
Sweden	311151
Austria	262309

Summary

Last updated: February 14, 2026

MICRONASE (glyburide) is an oral antihyperglycemic agent used to manage type 2 diabetes. Its market performance faces pressure from generic competition, emerging therapies, and regulatory challenges. Analyzing its investment scenario requires examining patent status, market share, competitors, regulatory trends, and pipeline developments.

Patent and Regulatory Status

Glyburide, the active ingredient in MICRONASE, was originally patented in the late 1960s. Its patent protections have long expired, primarily transitioning the product into generic markets since the early 2000s. FDA approval for MICRONASE remains active, with no recent formal brand-specific regulatory changes reported. However, regulatory shifts emphasizing newer drug classes (e.g., SGLT2 inhibitors, GLP-1 receptor agonists) influence its market position.

Market Fundamentals

Aspect	Details
Market Size (2022)	Estimated at $5.2 billion for oral antidiabetics globally[1]
MICRONASE’s Market Share	Historically around 2-3% of oral diabetes medications in the U.S.[2]
Pricing	Approx. $25–$50 per prescription, depending on formulary inclusion
Volume Trends	Declining due to substitution with newer agents and generics
Generic Competition	Present; several manufacturers produce glyburide tablets[3]

Recent data indicate a continuous decline in MICRONASE's sales volume, driven by generics and patent expiration.

Competitive Landscape

Competitor Class	Market Position	Key Products
SGLT2 Inhibitors	Market growth, new standard of care	Jardiance (empagliflozin), Invokana (canagliflozin)
GLP-1 Receptor Agonists	Increasing use for glycemic and cardiovascular benefits	Trulicity (dulaglutide), Victoza (liraglutide)
DPP-4 Inhibitors	Stable, moderate growth	Januvia (sitagliptin)

Glyburide and MICRONASE specifically face obsolescence pressures because of safety concerns (hypoglycemia risk, contraindications in renal impairment) and the benefits of newer agents with additional cardiovascular protection.

Pipeline and Development Trends

While no new formulations of MICRONASE are in advanced development, research continues into more stable, long-acting sulfonylureas. However, the focus remains on novel drug classes. No new proprietary formulations of MICRONASE are imminent.

Regulatory and Policy Considerations

Recent FDA guidelines promote the use of safer, more effective antidiabetic drugs. There is increased scrutiny on older therapies with safety issues, accelerating substitution with newer agents. Patent landscapes favor generic manufacturers, reducing exclusivity and profitability for the brand.

Financial Outlook

Metric	Observation
Revenue	Declined over the past decade, with minimal recent growth[2]
Profitability	Historically low margins for brand owing to generic competition; profits largely eroded[3]
R&D Investment	Not significant for MICRONASE as a product; focus on pipeline drugs

Unless a novel formulation or lipid-modified glyburide emerges, MICRONASE's prospects remain limited.

Investment Risks

• Patent expiry and generic erosion reduce revenue.
• Kinetic shifts toward newer classes diminish market relevance.
• Regulatory preferences favor therapies with better safety profiles.
• Healthcare payers and formularies favor cost-effective, newer options.

Key Takeaways

• MICRONASE operates in a mature, declining segment of oral antidiabetics.
• The lack of patent protection limits pricing power; generics dominate.
• Market share diminishes as clinicians prefer newer therapies with added benefits.
• Future growth prospects are minimal unless new formulations or combinations are developed.
• Investment should consider risks linked to patent expiration and competition.

FAQs

1. Why has MICRONASE's market share declined recently?
   Due to patent expiration, increased use of generics, and clinician preference for newer agents with better safety and efficacy profiles.

2. Are there opportunities for MICRONASE to innovate?
   Limited; no recent advancements or pipeline innovations for MICRONASE specifically are publicly reported. Focus remains on new drug classes.

3. How do regulatory trends impact older antidiabetics?
   Increased safety scrutiny favors newer drugs, discouraging long-term use of older agents like glyburide.

4. What is the outlook for generic glyburide manufacturers?
   Positive, as patent expiration means steady demand from patients switching from branded MICRONASE; however, market saturation limits growth.

5. Is MICRONASE a good investment?
   Given the mature status, patent expiry, and competition from newer therapies, MICRONASE presents limited investment upside without significant innovation or repositioning.

Citations

[1] IQVIA, Global Diabetes Market Report, 2022.
[2] Pharmacy Benefits Management Data, 2022.
[3] FDA Drug Approval and Evaluation Data, 2022.