GLIPIZIDE - Generic Drug Details

What are the generic drug sources for glipizide and what is the scope of freedom to operate?

Glipizide is the generic ingredient in five branded drugs marketed by Aurobindo Pharma, Endo Operations, Norvium Bioscience, Unique, Watson Labs, Zydus Pharms, Pfizer, Accord Hlthcare, Ani Pharms, Apotex, Aurobindo Pharma Usa, Barr Labs Inc, Chartwell Rx, Oxford Pharms, Rubicon, Sandoz, Sun Pharm Inds Inc, Watson Labs Teva, Dash Pharms, Epic Pharma Llc, Heritage, Teva Pharms, Zydus Pharms Usa Inc, and Bristol Myers Squibb, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for glipizide. Forty-two suppliers are listed for this compound.

Summary for GLIPIZIDE

US Patents:	0
Tradenames:	5
Applicants:	24
NDAs:	29
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	42
Patent Applications:	6,986
Drug Prices:	Drug price trends for GLIPIZIDE
Drug Sales Revenues:	Drug sales revenues for GLIPIZIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLIPIZIDE
What excipients (inactive ingredients) are in GLIPIZIDE?	GLIPIZIDE excipients list
DailyMed Link:	GLIPIZIDE at DailyMed

See drug prices for GLIPIZIDE

See drug sales revenues for GLIPIZIDE

Recent Clinical Trials for GLIPIZIDE

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

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	Phase 2
University of Michigan	Phase 1
Food and Drug Administration (FDA)	Phase 1

See all GLIPIZIDE clinical trials

Pharmacology for GLIPIZIDE

Drug Class

Sulfonylurea

Medical Subject Heading (MeSH) Categories for GLIPIZIDE

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for GLIPIZIDE

A10BB	Sulfonylureas
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for GLIPIZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	GLIPIZIDE	glipizide	TABLET, EXTENDED RELEASE;ORAL	203499-001	Jul 16, 2018	AB	RX	No	No
Bristol Myers Squibb	METAGLIP	glipizide; metformin hydrochloride	TABLET;ORAL	021460-001	Oct 21, 2002		DISCN	Yes	No
Teva Pharms	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	glipizide; metformin hydrochloride	TABLET;ORAL	077270-001	Oct 28, 2005	AB	RX	No	No
Zydus Pharms Usa Inc	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	glipizide; metformin hydrochloride	TABLET;ORAL	078905-002	Jan 31, 2011	AB	RX	No	No

Expired US Patents for GLIPIZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	GLUCOTROL	glipizide	TABLET;ORAL	017783-001	May 8, 1984	3,669,966
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-001	Apr 26, 1994	5,024,843
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	4,612,008
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329-002	Apr 26, 1994	5,591,454

GLIPIZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glipizide

Introduction

Glipizide, a second-generation sulfonylurea, is a widely used medication for the treatment of type 2 diabetes mellitus. Understanding the market dynamics and financial trajectory of glipizide is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The glipizide market is projected to experience significant growth over the coming years. The market size is expected to reach multimillion USD by 2032, driven by increasing prevalence of type 2 diabetes and the need for effective antidiabetic medications[1].

Regional Insights

The market for glipizide is not uniform across all regions. Different geographical areas have varying demands and growth rates. For instance, regions with higher diabetes prevalence and better healthcare infrastructure are likely to drive the market growth more significantly. Key success strategies for leading companies include targeting these high-demand regions and adapting to local market dynamics[4].

Trends and Drivers

Several trends and drivers are influencing the glipizide market:

Increasing Prevalence of Diabetes

The rising global incidence of type 2 diabetes is a major driver for the glipizide market. As more people are diagnosed with diabetes, the demand for effective antidiabetic medications like glipizide increases[1].

Advancements in Formulations

The development of extended-release formulations, such as Glipizide Gastrointestinal Therapeutic System (GITS), has improved patient compliance and therapeutic outcomes. These advancements contribute to the market growth by offering more stable plasma drug concentrations and better glycemic control[3].

Pharmacoeconomic Advantages

Glipizide GITS has been shown to have pharmacoeconomic advantages over other antidiabetic agents like metformin and acarbose. It offers better cost outcomes and improved patient compliance, making it a preferred choice for first-line therapy in many cases[3].

Challenges

Despite the growth potential, the glipizide market faces several challenges:

Competitive Landscape

The antidiabetic drug market is highly competitive, with numerous other medications available. Glipizide must compete with other sulfonylureas, as well as newer classes of antidiabetic drugs, to maintain its market share[4].

Regulatory Environment

Changes in regulatory policies and healthcare reimbursement strategies can impact the market dynamics of glipizide. Pharmaceutical companies must navigate these changes to ensure continued market access and profitability[4].

Safety and Efficacy Concerns

The use of glipizide, especially in combination with other drugs like losartan, can lead to complex interactions and potential safety issues. For example, studies have shown that glipizide and losartan can compete for binding sites on albumin, which may affect their therapeutic efficacy and safety[2].

Financial Trajectory

The financial trajectory of glipizide is influenced by several factors:

Cost of Treatment

Glipizide GITS has been shown to be the least costly strategy for first-line therapy in a 3-year treatment model for type 2 diabetes. The total per-patient cost with glipizide GITS was lower compared to metformin and acarbose, making it a financially attractive option[3].

Productivity and Quality of Life

Treatment with glipizide GITS has been associated with improved quality of life and reduced productivity losses. In a US study, monthly productivity losses related to absenteeism were significantly lower in the glipizide GITS group compared to the placebo group[3].

Market Opportunities

The growing demand for antidiabetic medications presents significant market opportunities for glipizide. Pharmaceutical companies can capitalize on these opportunities by focusing on regions with high diabetes prevalence and by developing innovative formulations and delivery systems[4].

Key Players and Strategies

Leading companies in the glipizide market employ various strategies to maintain and expand their market share:

Innovation in Formulations

Companies are investing in research and development to create more effective and patient-friendly formulations of glipizide. The extended-release formulation, for example, has been a key factor in the drug's success[3].

Market Expansion

Expanding into new geographical markets, especially in regions with high diabetes prevalence, is a critical strategy. Companies are also focusing on building strong distribution networks and partnerships to enhance market access[4].

Regulatory Compliance

Ensuring compliance with changing regulatory requirements is essential for maintaining market presence. Companies must stay updated with the latest guidelines and adapt their strategies accordingly[4].

Conclusion

The market for glipizide is poised for significant growth driven by the increasing prevalence of type 2 diabetes and the pharmacoeconomic advantages of its extended-release formulations. However, the market also faces challenges such as competition from other antidiabetic drugs and regulatory complexities. By focusing on innovation, market expansion, and regulatory compliance, pharmaceutical companies can capitalize on the opportunities presented by the glipizide market.

Key Takeaways

• The glipizide market is expected to reach multimillion USD by 2032.
• Glipizide GITS offers better cost outcomes and improved patient compliance compared to other antidiabetic agents.
• The drug faces competition from other classes of antidiabetic medications.
• Regulatory changes and safety concerns are key challenges.
• Market expansion into high-prevalence regions is a critical strategy.

FAQs

What is glipizide and how is it used?

Glipizide is a second-generation sulfonylurea used to treat type 2 diabetes mellitus by stimulating insulin release from the pancreas.

What are the advantages of Glipizide GITS?

Glipizide GITS provides more stable plasma drug concentrations, improves patient compliance, and offers better cost outcomes compared to other antidiabetic agents.

How does glipizide interact with other drugs?

Glipizide can interact with other drugs like losartan, competing for binding sites on albumin, which may affect their therapeutic efficacy and safety[2].

What are the key drivers of the glipizide market?

The key drivers include the increasing prevalence of type 2 diabetes, advancements in formulations, and pharmacoeconomic advantages.

What challenges does the glipizide market face?

The market faces challenges such as competition from other antidiabetic drugs, regulatory complexities, and safety concerns related to drug interactions.

Sources

1. Glipizide Market Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2024 to 2032. NEWS CHANNEL NEBRASKA.
2. In Vitro Spectroscopic Investigation of Losartan and Glipizide Competitive Binding to Glycated Albumin: A Comparative Study. International Journal of Molecular Sciences.
3. Glipizide. A review of the pharmacoeconomic implications. PubMed.
4. Glipizide Market Analysis: Regional Insights and Future Growth P. WICZ.
5. 16. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes. Diabetes Care.