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. Twenty 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:	152
Clinical Trials:	6
Patent Applications:	4,279
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	017498-003	May 1, 1984
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

International Patents for MICRONASE

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

Country	Patent Number	Title	Estimated Expiration
Finland	45959
Cyprus	436	Benzenesulphonyl-ureas and process for their manufacture
India	139501	PROCESS FOR THE MANUFACTURE OF BENZENSULFONYL-UREAS
Germany	1301812	Verfahren zur Herstellung von Benzolsulfonylharnstoffen

MICRONASE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MICRONASE

Overview of MICRONASE

MICRONASE, containing the active ingredient glyburide, is an oral blood-glucose-lowering drug of the sulfonylurea class. It is widely used in the management of type 2 diabetes to help control blood sugar levels.

Market Size and Growth

The sulfonylureas market, which includes MICRONASE, is projected to experience steady growth over the coming years. As of 2024, the sulfonylureas market is estimated to be valued at USD 9.98 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.12% to reach USD 11.32 billion by 2029[1].

Regional Market Performance

North America

North America currently holds the largest market share in the sulfonylureas market, driven by a high prevalence of diabetes and well-established healthcare infrastructure. This region is expected to continue its dominance due to the increasing incidence of diabetes and the availability of advanced healthcare services[1].

Middle East and Africa

The Middle East and Africa region is anticipated to be the fastest-growing market for sulfonylureas, including MICRONASE. This growth is attributed to the alarming increase in the prevalence of diabetes in this region, largely due to lifestyle changes. By 2030, the number of adults living with diabetes in the IDF MENA Region is expected to rise from 73 million in 2021 to 95 million[1].

Impact of COVID-19

The COVID-19 pandemic has significantly influenced the sulfonylureas market. The increased prevalence of diabetes among patients hospitalized with COVID-19 and the recognition of improved glycemic control as a factor in better patient outcomes have heightened the demand for oral anti-diabetic drugs like MICRONASE. This has contributed to the market's growth globally[1].

Key Players and Competition

The sulfonylureas market, including MICRONASE, is competitive with several major players such as Sanofi Aventis, Pfizer Inc., Merck & Co., Inc., Torrent Pharma, and Dr. Reddy's Laboratories. These companies play a crucial role in driving market growth through their extensive product portfolios and strong distribution networks[1].

Clinical and Safety Considerations

Efficacy and Dosage

MICRONASE has been shown to effectively lower blood glucose levels in diabetic patients. The drug's efficacy is dose-dependent, and it is typically administered in doses ranging from 1.25 to 20 mg daily. The maintenance dose is often adjusted based on the patient's blood glucose levels[2].

Safety and Adverse Reactions

While effective, MICRONASE can cause severe hypoglycemia, a critical safety concern. Other potential adverse reactions include gastrointestinal disturbances, allergic skin reactions, and liver function abnormalities. Patients must be closely monitored for these side effects, and dosage adjustments may be necessary to mitigate risks[2].

Financial Trajectory

Revenue Projections

Given the overall growth of the sulfonylureas market, MICRONASE is expected to contribute significantly to the revenue of its manufacturers. The market's projected growth from USD 9.98 billion in 2024 to USD 11.32 billion by 2029 indicates a stable financial trajectory for MICRONASE and similar drugs[1].

Cost and Pricing

The cost of MICRONASE can vary based on regional healthcare policies and market dynamics. However, the average cost per oral antidiabetes drug prescription has been increasing over the years, partly due to the introduction of more costly antidiabetes drugs. This trend may influence the pricing strategy for MICRONASE and other sulfonylureas[5].

Market Drivers

Increasing Prevalence of Diabetes

The rising prevalence of diabetes globally, particularly in regions like the Middle East and Africa, is a significant driver for the sulfonylureas market. As more people are diagnosed with type 2 diabetes, the demand for effective oral antidiabetic drugs like MICRONASE is expected to increase[1].

Lifestyle Changes

Lifestyle changes, including dietary habits and physical inactivity, are contributing to the growing incidence of diabetes. This trend is particularly pronounced in the Middle East and Africa, where the rate of diabetes is at an all-time high[1].

Healthcare Infrastructure

The availability and accessibility of advanced healthcare services in regions like North America also drive the market for MICRONASE. Well-established healthcare infrastructure ensures that more patients have access to these medications, contributing to market growth[1].

Market Challenges

Competition from New Therapies

The emergence of new therapies, such as GLP-1s (Glucagon-like peptide-1 receptor agonists), poses a challenge to traditional oral antidiabetic drugs like MICRONASE. The growing demand for GLP-1s, driven by their clinical efficacy and weight loss benefits, may divert some market share away from sulfonylureas[4].

Safety Concerns

The potential for severe hypoglycemia and other adverse reactions associated with MICRONASE can be a deterrent for some patients and healthcare providers. This necessitates careful patient selection and dosage management to minimize risks[2].

Key Takeaways

• The sulfonylureas market, including MICRONASE, is expected to grow from USD 9.98 billion in 2024 to USD 11.32 billion by 2029.
• The Middle East and Africa region is anticipated to be the fastest-growing market.
• North America holds the largest market share due to its well-established healthcare infrastructure.
• The COVID-19 pandemic has highlighted the importance of effective glycemic control, boosting demand for MICRONASE.
• Safety concerns and competition from new therapies are key challenges for the market.

FAQs

What is the expected market size of the sulfonylureas market by 2029?

The sulfonylureas market is expected to reach USD 11.32 billion by 2029[1].

Which region is the fastest-growing market for sulfonylureas?

The Middle East and Africa region is expected to witness the highest CAGR in the sulfonylureas market over the forecast period[1].

What are the potential adverse reactions associated with MICRONASE?

MICRONASE can cause severe hypoglycemia, gastrointestinal disturbances, allergic skin reactions, and liver function abnormalities[2].

How has the COVID-19 pandemic impacted the sulfonylureas market?

The COVID-19 pandemic has increased the demand for oral anti-diabetic drugs like MICRONASE due to the importance of glycemic control in patient outcomes[1].

Who are the major players in the sulfonylureas market?

Major players include Sanofi Aventis, Pfizer Inc., Merck & Co., Inc., Torrent Pharma, and Dr. Reddy's Laboratories[1].

Sources:

1. Mordor Intelligence: Sulfonylureas Market - Share, Size & Growth.
2. FDA: Micronase glyburide tablets, USP For Oral Use.
3. Mordor Intelligence: Microneedle Drug Delivery Systems Market Size & Share Analysis.
4. IQVIA: New Demand in an Old Market.
5. CADTH: Optimal Therapy Report.