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. Twenty 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:	152
Clinical Trials:	4
Patent Applications:	4,336
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	3,507,961
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-003	Sep 24, 1993	4,916,163
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992	4,735,805
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-002	Mar 4, 1992	3,507,954
Pfizer	GLYNASE	glyburide	TABLET;ORAL	020051-001	Mar 4, 1992	3,426,067

International Patents for GLYNASE

See the table below for patents covering GLYNASE 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
Switzerland	478105	Verfahren zur Herstellung von Benzolsulfonylharnstoffen

GLYNASE Market Analysis and Financial Projection Experimental

The Rise of GLP-1 Medications: Understanding Market Dynamics and Financial Trajectory

Introduction

The pharmaceutical market has witnessed significant growth in recent years, particularly in the segment of antidiabetic and weight management drugs. Among these, Glucagon-Like Peptide-1 (GLP-1) medications have emerged as a dominant force, transforming the way diabetes and obesity are managed. This article delves into the market dynamics and financial trajectory of GLP-1 medications, highlighting key trends, drivers, and future projections.

Market Growth of GLP-1 Medications

Historical Context

Since the approval of the first GLP-1 medication in the mid-2000s, the market has seen substantial growth. By 2023, the GLP-1 category reached $30 billion in sales for diabetes management alone, with a projected expansion into the obesity treatment market[2].

Current Market Size

The global GLP-1 market is expected to grow significantly. Estimates suggest that by 2030, the market could reach $100 billion, driven by increasing patient populations and broader therapeutic applications[3].

Key Drivers of Market Growth

Therapeutic Versatility

GLP-1 medications are not only effective for diabetes management but also for weight loss and treating various comorbid conditions such as heart failure, chronic kidney disease, sleep apnea, and fatty liver disease. This broad utility has significantly enhanced their market potential[2].

Expanding Indications

Recent approvals, such as the FDA's approval of Wegovy for the prevention of heart disease, have expanded the indications for GLP-1 medications. Ongoing studies for treating Alzheimer’s disease and substance addictions further underscore their therapeutic potential[3].

Biosimilar and Generic Competition

While the new-generation/non-insulin drugs, including GLP-1s, were still patented during the last decade, the introduction of biosimilars in the insulin market has offered opportunities for savings. However, generic competition for GLP-1s is expected to be gradual[1].

Market Leaders and Competitive Landscape

Dominant Players

Eli Lilly and Novo Nordisk are the current leaders in the GLP-1 market, benefiting from significant scale advantages in production, development, and sales. These companies are investing heavily in next-generation medicines and enhancing their supply chain capabilities[2].

Emerging Trends

The development of oral GLP-1 medications is a significant trend. Novo Nordisk's Rybelsus, an oral semaglutide, is already approved for diabetes, and similar oral formulations for weight loss are in clinical trials. These oral versions are expected to be more cost-effective and could further expand the market[2].

Financial Impact and Budget Considerations

Budget Impact Analysis

Studies have shown that GLP-1 medications like semaglutide, tirzepatide, and dulaglutide have significant financial impacts on healthcare systems. For instance, semaglutide's cumulative budget impact over a 5-year period was estimated at $85,923,091. These medications offer cost offsets through reduced cardiovascular events and other health benefits[5].

Pricing and Reimbursement

The financial trajectory of GLP-1 medications is influenced by pricing and reimbursement policies. Lower price points, potentially due to increased competition and the introduction of oral formulations, are expected to make these drugs more accessible. However, public sector coverage, such as Medicare, remains uncertain and is a critical factor in determining the market size[3].

Regional Market Dynamics

Canada

In Canada, spending on antidiabetic drugs, particularly GLP-1s, has increased substantially from $0.9 billion in 2012 to $2.7 billion in 2021. Provincial biosimilar switching policies and the introduction of new insulins like insulin degludec have significantly impacted the market[1].

United States

The U.S. market is projected to see significant growth, with the patient population for GLP-1s expected to increase from 2 million to 15 million by 2030. Employer coverage is anticipated to rise due to employee demand and demonstrated health benefits[3].

Global Outlook

The global diabetes drugs market, including GLP-1s, is estimated to reach $205.3 billion by 2030, growing at a CAGR of 9.3%. Regional growth trends vary, with the U.S. and China being key markets[4].

Impact on Related Industries

Healthcare and Medical Devices

The rise of GLP-1 medications has implications for various healthcare sectors. For example, manufacturers of robotic equipment used in bariatric surgeries have seen a slowdown in demand as patients opt for GLP-1 treatments. Similarly, the demand for CPAP devices and joint replacements may be affected[2].

Broader Economic Impact

The widespread adoption of GLP-1 medications could have far-reaching economic implications, affecting industries such as food, beauty products, and airlines. The potential reduction in obesity-related health issues could lead to significant economic savings and changes in consumer behavior[3].

Future Projections and Challenges

Market Expansion

The potential market for GLP-1s could represent a significant portion of the entire prescription drug market. With ongoing studies and expanded indications, the market is poised for further growth[2].

Regulatory and Reimbursement Challenges

Despite the promising outlook, challenges related to regulatory approvals and reimbursement policies remain. Public sector coverage, particularly in the U.S., is uncertain and could impact the market size[3].

Key Takeaways

• Substantial Market Growth: The GLP-1 market has seen significant growth, reaching $30 billion in sales by 2023 and projected to reach $100 billion by 2030.
• Therapeutic Versatility: GLP-1 medications are effective for diabetes, weight loss, and various comorbid conditions.
• Market Leaders: Eli Lilly and Novo Nordisk dominate the market due to their scale advantages and investments in next-generation medicines.
• Financial Impact: GLP-1 medications offer cost offsets through reduced health complications but face challenges in pricing and reimbursement.
• Regional Dynamics: The U.S. and Canada are key markets, with significant growth projected in the coming years.

FAQs

Q: What is the current market size of GLP-1 medications? A: By 2023, the GLP-1 category reached $30 billion in sales for diabetes management alone and is projected to grow further[2].

Q: Which companies are leading the GLP-1 market? A: Eli Lilly and Novo Nordisk are the current leaders, benefiting from significant scale advantages in production, development, and sales[2].

Q: What are the key drivers of the growing market for GLP-1 medications? A: The therapeutic versatility, expanding indications, and the development of oral formulations are key drivers of the growing market[2][3].

Q: How do GLP-1 medications impact related industries? A: The rise of GLP-1 medications affects various healthcare sectors and industries such as food, beauty products, and airlines due to reduced obesity-related health issues[2].

Q: What are the challenges facing the GLP-1 market? A: Regulatory approvals and reimbursement policies, particularly public sector coverage, remain significant challenges for the market[3].

Sources

1. Market Intelligence Report: Antidiabetic Drugs, 2012-2021 - Canada.ca
2. Waistlines and GLP1-s—Expanding in Unison - William Blair
3. Weighing the GLP-1 market - Goldman Sachs
4. Diabetes Drugs Global Strategic Business Report 2024 - GlobeNewswire
5. Budget impact analysis for three glucagon-like peptide-1 receptor agonists - Tandfonline.com