GLYNASE Drug Patent Profile

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

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

The generic ingredient in GLYNASE 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 Glynase

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

Summary for GLYNASE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	4
Patent Applications:	4,295
Drug Prices:	Drug price information for GLYNASE
What excipients (inactive ingredients) are in GLYNASE?	GLYNASE excipients list
DailyMed Link:	GLYNASE at DailyMed

See drug prices for GLYNASE

Recent Clinical Trials for GLYNASE

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

Sponsor	Phase
Medical College of Wisconsin	Phase 4
Texas Tech University Health Sciences Center, El Paso	Early Phase 1
Takeda	Phase 4

See all GLYNASE clinical trials

US Patents and Regulatory Information for GLYNASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992	AB	RX	Yes	No
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-004	Sep 24, 1993	AB	RX	Yes	Yes
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	AB	RX	Yes	No
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-003	Sep 24, 1993		DISCN	Yes	No

Expired US Patents for GLYNASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-004	Sep 24, 1993
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992

International Patents for GLYNASE

See the table below for patents covering GLYNASE 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 Glynase (Prandin)

Last updated: July 29, 2025

Introduction

Glynase, marketed under the generic name Prandin in the United States and Glynase PresTab elsewhere, is an oral antidiabetic medication containing repaglinide, a short-acting insulin secretagogue. Approved by the FDA in 1997, Glynase plays a significant role in managing Type 2 diabetes mellitus (T2DM). Over the past decades, its market dynamics and financial trajectory have been influenced by evolving scientific insights, competitive landscape, regulatory policies, and societal health trends.

This analysis explores the current market environment for Glynase, its historical financial performance, and future prospects within the global pharmaceutical landscape.

Market Dynamics in the Glynase Segment

1. Rising Global Prevalence of Type 2 Diabetes

T2DM continues to be a global health crisis, with the International Diabetes Federation (IDF) reporting over 537 million adults affected globally in 2021, projected to reach 643 million by 2030. This increase fuels demand for effective antidiabetic therapies, including repaglinide-based drugs like Glynase. The expanding market base consistently underpins sustained demand for insulin secretagogues, especially in regions with rising urbanization and lifestyle changes influencing diabetes prevalence.

2. Competitive Therapeutic Landscape

While Glynase remains a pivotal option for some patients, the diabetes treatment landscape has diversified considerably:

• Biguanides (e.g., Metformin): often first-line due to efficacy and safety profile.
• Sitagliptin, Saxagliptin: DPP-4 inhibitors with favorable tolerability.
• GLP-1 receptor agonists: offering weight loss benefits.
• SGLT2 inhibitors: providing cardiovascular and renal protection.

Repaglinide faces stiff competition from these newer agents, especially given that some class effects extend beyond glycemic control, influencing prescribing preferences.

3. Regulatory and Prescribing Trends

Regulatory authorities, including the FDA and EMA, continuously evaluate antidiabetic drugs’ safety profiles. In 2003, the FDA issued a warning regarding the risk of hypoglycemia associated with repaglinide, influencing physician prescribing behavior. As safety profiles of newer agents improve, the reliance on mealtime insulin secretagogues like Glynase has slightly declined, especially among cautious clinicians.

4. Cost and Patent Landscape

Glynase's patent protections expired in the late 2000s, paving the way for generic versions which have significantly reduced costs. Price competition has enhanced access but also compressed profit margins for branded formulations. The dynamics of generics have shifted the market towards affordability, especially in low- and middle-income regions.

5. Evolving Treatment Guidelines

Treatment guidelines nowadays emphasize personalized medicine, incorporating patient-specific factors. While repaglinide remains a viable option, guidelines increasingly recommend newer agents due to their favorable safety profiles and additional benefits, such as weight loss or cardiovascular protection.

Financial Trajectory of Glynase

1. Revenue Trends

Glynase historically contributed robust revenues during the late 1990s and early 2000s, driven by high prevalence rates and limited competition. Post-2000s, revenue growth plateaued, reflecting market saturation and competition from novel therapies.

Recent years show a declining trend in branded sales, partly compensated by increased sales of generics. In developed markets like the US, Glynase’s sales have been relatively stable but modest, constrained by regulatory warnings and competitive fallback.

2. Impact of Patent Expiry and Generic Entry

The expiration of patent protections led to an influx of generic repaglinide formulations, which significantly eroded Glynase's market share. According to IQVIA data, generic formulations captured a majority of prescriptions in key markets by 2012, leading to substantial revenue decline for the branded product.

3. Market Penetration in Emerging Economies

Emerging economies represent a growth avenue for Glynase due to increasing diabetes prevalence and demand for affordable medications. Local manufacturers and generics play a prominent role here, with pharmaceutical companies potentially expanding distribution channels.

4. Future Revenue Potential

The longevity of Glynase’s revenue depends on:

• Prescriber acceptance amid safety concerns.
• Market share retention against new therapies.
• Expansion in markets with growing diabetes burdens.
• Pricing strategies to combat generic competition.

Forecasts suggest a continued decline in branded sales in mature markets, with potential stabilization in emerging regions.

5. Investment and R&D Considerations

Despite its age, repaglinide remains relevant, with some companies investing in formulations that combine repaglinide with other agents or modify delivery methods. However, large R&D investments are focusing on novel agents, which could marginalize older drugs like Glynase further.

Factors Influencing Future Market Dynamics

• Pharmacovigilance: Ongoing safety monitoring could influence prescribing patterns.
• Policy Changes: Increased emphasis on cost-effective therapies may sustain demand in price-sensitive markets.
• Combination Therapies: Development of fixed-dose combinations involving Glynase could rejuvenate its market presence.
• Digital Health Integration: Software tools for personalized dosing may optimize older agents’ utility.

Conclusion & Outlook

Glynase's market and financial trajectories are emblematic of a typical "legacy" type of pharmaceutical agent: initially dominant, then gradually challenged by innovation and regulatory scrutiny. While current global trends project a declining revenue outlook in developed markets, emerging economies offer substantial opportunities for Glynase, especially if manufacturers adapt pricing and formulation strategies.

The long-term viability of Glynase hinges on its positioning relative to newer therapies, safety profile management, and strategic market expansion. Pharmaceutical stakeholders must evaluate whether to continue investment in this drug or pivot towards developing or marketing newer antidiabetic agents.

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Key Takeaways

• The global increase in diabetes prevalence sustains demand for oral antidiabetics, including Glynase, despite competition.
• Patent expiry and the introduction of generics have considerably reduced Glynase's revenue in mature markets.
• Safety concerns and shifting treatment guidelines favor newer, cardiovascular and weight-lossic agents over repaglinide.
• Emerging markets present growth potential through affordability and expanding healthcare infrastructure.
• Strategic differentiation, such as combination formulations or targeted marketing, could mitigate revenue decline.

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FAQs

1. What are the primary advantages of Glynase over other antidiabetic agents?
Glynase offers rapid mealtime glycemic control, low risk of long-term hypoglycemia, and simplicity of oral administration, making it suitable for certain patient populations. However, its advantages are often weighed against safety risks and newer therapies' added benefits.

2. How has patent expiration affected Glynase’s market share?
Patent expiry led to the proliferation of generic repaglinide formulations, significantly reducing sales of branded Glynase as generic versions became available at lower prices.

3. What safety concerns are associated with Glynase?
The most notable concern is hypoglycemia, particularly if dosing is not appropriately managed. Regulatory warnings and safety warnings have influenced prescriber preferences.

4. Are there new formulations or combinations of Glynase in development?
Current R&D efforts are limited; most focus on newer agents. However, some manufacturers have explored fixed-dose combinations involving repaglinide to enhance adherence and efficacy.

5. What is the outlook for Glynase in the next decade?
While it remains relevant in certain markets, the global trend favors newer agents. Glynase’s future depends on market positioning, safety management, and attractive pricing strategies aimed at emerging economies.

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References
[1] International Diabetes Federation. Diabetes Atlas, 2021.
[2] IQVIA. Market reports on antidiabetic medications, 2022.
[3] U.S. Food and Drug Administration. Safety Warnings and Drug Labels for Repaglinide, 2003.