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Last Updated: December 22, 2024

GLIPIZIDE AND METFORMIN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Glipizide And Metformin Hydrochloride, and what generic alternatives are available?

Glipizide And Metformin Hydrochloride is a drug marketed by Dash Pharms, Epic Pharma Llc, Heritage, Sun Pharm Inds Inc, Teva Pharms, and Zydus Pharms Usa Inc. and is included in six NDAs.

The generic ingredient in GLIPIZIDE AND METFORMIN HYDROCHLORIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Glipizide And Metformin Hydrochloride

A generic version of GLIPIZIDE AND METFORMIN HYDROCHLORIDE was approved as glipizide; metformin hydrochloride by EPIC PHARMA LLC on October 27th, 2005.

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Summary for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Drug patent expirations by year for GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Recent Clinical Trials for GLIPIZIDE AND METFORMIN HYDROCHLORIDE

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 4
The Catholic University of KoreaPhase 4
Bristol-Myers SquibbPhase 4

See all GLIPIZIDE AND METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for GLIPIZIDE AND METFORMIN HYDROCHLORIDE

US Patents and Regulatory Information for GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dash Pharms GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078083-001 Apr 12, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms Usa Inc GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078905-003 Jan 31, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Heritage GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728-001 Jun 23, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 077507-001 Oct 27, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 077620-003 Jan 11, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Heritage GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728-002 Jun 23, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

GLIPIZIDE AND METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glipizide and Metformin Hydrochloride

Introduction

Glipizide and metformin hydrochloride, combined in medications like METAGLIP, represent a significant segment in the treatment of type 2 diabetes mellitus (T2DM). This combination therapy has been proven to be highly effective in improving glycemic control, making it a crucial component in the management of T2DM. Here, we delve into the market dynamics and financial trajectory of this drug combination.

Efficacy and Clinical Outcomes

The combination of glipizide and metformin hydrochloride has demonstrated superior efficacy compared to monotherapies of either drug. Clinical trials have shown that this combination significantly reduces HbA1c levels, fasting plasma glucose (FPG), and postprandial glucose levels, without significantly affecting fasting insulin levels[2][5].

Market Demand

The demand for glipizide and metformin hydrochloride combination tablets is driven by the increasing prevalence of type 2 diabetes globally. As the population ages and obesity rates rise, the need for effective and cost-efficient treatments becomes more pressing. This combination therapy addresses the dual issues of insulin resistance and impaired insulin secretion, making it a preferred choice for many healthcare providers[5].

Cost-Effectiveness

One of the key factors influencing the market dynamics of glipizide and metformin hydrochloride is its cost-effectiveness. The combination therapy is often more economical than using the two drugs separately, which can be a significant advantage in healthcare systems where cost is a critical factor. Studies have highlighted that this combination is not only effective but also cost-efficient, making it accessible to a broader patient population[1].

Competitive Landscape

The market for antidiabetic medications is highly competitive, with various classes of drugs such as SGLT2 inhibitors, DPP-4 inhibitors, and thiazolidinediones. However, the combination of glipizide and metformin hydrochloride remains a staple due to its established efficacy and safety profile. The market dynamics are influenced by the presence of generic versions of these drugs, which can impact pricing and market share[4].

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in shaping the market for glipizide and metformin hydrochloride. The FDA has approved this combination for use as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. Regulatory bodies continue to monitor the safety and efficacy of this combination, ensuring that it meets the highest standards of care[2].

Financial Performance

The financial performance of glipizide and metformin hydrochloride combination tablets is robust, driven by their widespread use and acceptance. The market for these tablets is expected to grow steadily over the next few years, driven by increasing demand and the expanding diabetic population. According to market research, the metformin hydrochloride and glipizide tablets market is projected to continue its growth trajectory through 2030, reflecting the ongoing need for effective and affordable diabetes treatments[4].

Market Trends

Several trends are influencing the market dynamics of glipizide and metformin hydrochloride:

  • Generic Competition: The availability of generic versions of these drugs can impact pricing and market share. However, branded versions often maintain market presence due to their established reputation and patient loyalty.
  • Combination Therapies: The trend towards combination therapies is on the rise, as they offer synergistic benefits and improved patient outcomes. This trend is expected to continue, driving demand for glipizide and metformin hydrochloride combination tablets.
  • Patient Compliance: Simplified dosing regimens, such as combination tablets, improve patient compliance, which is a critical factor in managing chronic conditions like diabetes.

Patient and Healthcare Provider Preferences

Patient and healthcare provider preferences also play a significant role in the market dynamics. The convenience of a single tablet that combines two effective antidiabetic agents is a major advantage. Additionally, the well-documented safety and efficacy profile of this combination makes it a preferred choice among healthcare providers[5].

Illustrative Statistics

  • Clinical Efficacy: In clinical trials, glipizide/metformin combination tablets reduced HbA1c levels by up to 1.06% more than glipizide monotherapy and 0.98% more than metformin monotherapy[5].
  • Market Growth: The metformin hydrochloride and glipizide tablets market is expected to grow significantly through 2030, driven by the increasing prevalence of type 2 diabetes[4].
  • Patient Outcomes: Approximately 36.3% of patients treated with glipizide/metformin combination tablets achieved an HbA1c level < 7.0%, compared to 8.9% and 9.9% for glipizide and metformin monotherapies, respectively[5].

Conclusion

The combination of glipizide and metformin hydrochloride is a cornerstone in the management of type 2 diabetes, offering superior efficacy, cost-effectiveness, and patient compliance. The market dynamics are influenced by regulatory approvals, competitive landscape, and patient preferences. As the global diabetic population continues to grow, the demand for this combination therapy is expected to remain strong, driving its financial trajectory positively.

Key Takeaways

  • Efficacy: Glipizide and metformin hydrochloride combination tablets are more effective than monotherapies in controlling HbA1c and FPG.
  • Cost-Effectiveness: This combination is often more economical than separate therapies.
  • Market Growth: The market for these tablets is expected to grow through 2030.
  • Regulatory Environment: FDA approval and ongoing regulatory monitoring ensure safety and efficacy.
  • Patient Compliance: Simplified dosing regimens improve patient compliance.

FAQs

Q: What is the primary advantage of combining glipizide and metformin hydrochloride? A: The primary advantage is the synergistic effect on insulin resistance and beta cell dysfunction, leading to better glycemic control.

Q: How does the combination of glipizide and metformin hydrochloride compare to monotherapies? A: Clinical trials have shown that this combination is more effective in reducing HbA1c and FPG levels compared to either drug used alone.

Q: What is the expected market growth for glipizide and metformin hydrochloride combination tablets? A: The market is expected to grow steadily through 2030, driven by increasing demand and the expanding diabetic population.

Q: Are there any significant side effects associated with glipizide and metformin hydrochloride combination therapy? A: The therapy is generally well-tolerated, with a low incidence of hypoglycemia and no significant impact on fasting insulin levels.

Q: How does the regulatory environment impact the market for glipizide and metformin hydrochloride? A: FDA approval and ongoing regulatory monitoring ensure that the combination meets the highest standards of safety and efficacy, influencing market dynamics and patient trust.

Sources

  1. A Review on Affordable Combinations in Type 2 Diabetes Care - Cureus
  2. METAGLIP™ (glipizide and metformin HCl) Tablets - FDA
  3. Clinical Review for FARXIGA (dapagliflozin) - FDA
  4. Metformin Hydrochloride & Glipizide Tablets Market 2025-2030 - 360 Research Reports
  5. Multicenter, randomized, double-masked, parallel-group study - PubMed

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