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Last Updated: December 26, 2024

GLYBURIDE AND METFORMIN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Glyburide And Metformin Hydrochloride, and when can generic versions of Glyburide And Metformin Hydrochloride launch?

Glyburide And Metformin Hydrochloride is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Heritage, Impax Labs Inc, Teva, and Zydus Pharms. and is included in seven NDAs.

The generic ingredient in GLYBURIDE AND METFORMIN HYDROCHLORIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

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

A generic version of GLYBURIDE AND METFORMIN HYDROCHLORIDE was approved as glyburide; metformin hydrochloride by IMPAX LABS INC on February 18th, 2004.

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

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

SponsorPhase
The University of Texas Health Science Center, HoustonPhase 4
University of Illinois at ChicagoPhase 3
Texas Tech University Health Sciences CenterPhase 3

See all GLYBURIDE AND METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for GLYBURIDE AND METFORMIN HYDROCHLORIDE

US Patents and Regulatory Information for GLYBURIDE 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
Actavis Elizabeth GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076716-001 Jun 28, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076821-003 Jan 27, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Heritage GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 079009-001 Jun 3, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 077870-001 Nov 14, 2007 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Impax Labs Inc GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076345-002 Feb 18, 2004 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 206748-002 Feb 29, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Heritage GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 079009-002 Jun 3, 2009 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

GLYBURIDE AND METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Glyburide and Metformin Hydrochloride

Introduction

Glyburide and Metformin Hydrochloride, a combination therapy for Type 2 diabetes, is a pivotal medication in the global healthcare landscape. This article delves into the market dynamics, financial trajectory, and future outlook of this essential drug.

Growing Demand for Diabetes Management

The global prevalence of Type 2 diabetes, affecting over 400 million adults, drives the demand for effective management solutions. Factors such as increasing obesity, sedentary lifestyles, and aging populations further exacerbate this demand. According to the American Diabetes Association, nearly 90% of individuals diagnosed with Type 2 diabetes are overweight or obese, highlighting the urgent need for treatments like Glyburide and Metformin Hydrochloride[1].

Market Dynamics: Opportunities and Challenges

Combination Therapy Efficacy

Clinical trials have shown that Glyburide and Metformin Hydrochloride tablets offer superior glycemic control compared to monotherapy with either glyburide or metformin. A multicenter, double-blind trial demonstrated a mean reduction in A1C levels of -2.27% with the combination therapy, significantly better than the reductions achieved with glyburide (-1.90%) or metformin (-1.53%) alone[2].

Generic Versions and Cost-Effectiveness

The expiration of patents has led to an influx of generic versions of Glyburide and Metformin Hydrochloride, making these medications more accessible and affordable. This shift is expected to increase competition, prompting branded manufacturers to innovate and differentiate their products through enhanced formulations and value-added features[1].

Regional Insights

The market dynamics vary across geographical regions, influenced by factors such as diabetes prevalence, healthcare infrastructure, and regulatory frameworks. In North America, particularly the United States, the high demand for combination therapies is driven by the rising incidence of Type 2 diabetes and advanced healthcare facilities. The Asia-Pacific region, with countries like India and China experiencing rapid urbanization and lifestyle changes, is also emerging as a significant market[1].

Competitive Landscape

The competitive landscape of the Glyburide and Metformin Hydrochloride market is dynamic, with key players leveraging advanced technologies and innovative formulations to enhance product efficacy and safety. Companies are exploring combination therapies that integrate Glyburide and Metformin with other antidiabetic agents to provide synergistic effects, improving glycemic control and patient compliance[1].

Financial Trajectory

Market Size and Growth

The global market for Glyburide and Metformin Hydrochloride is poised for significant growth. The increasing prevalence of Type 2 diabetes, projected to reach approximately 700 million adults by 2045, drives the demand for effective therapeutic options. The market is expected to benefit from technological advancements in drug formulation and delivery systems, as well as a shift towards personalized medicine[1].

Metformin Hydrochloride Market Insights

The global Metformin Hydrochloride market, a key component of the combination therapy, was valued at US$ 392 million in 2023 and is anticipated to reach US$ 565 million by 2030, witnessing a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period 2024-2030[4].

Key Manufacturers and Market Share

Key manufacturers such as Keyuan Pharmaceutical, Aarti Drugs, and Shijiazhuang Polee Pharmaceutical dominate the Metformin Hydrochloride market. These companies hold a significant market share, with Keyuan Pharmaceutical being the largest manufacturer, holding more than 14% of the market share[4].

Future Outlook

Technological Advancements

Technological innovations in drug formulation and delivery systems are expected to enhance the efficacy and safety profiles of Glyburide and Metformin Hydrochloride. Controlled-release formulations and personalized medicine approaches are likely to improve patient adherence and health outcomes[1].

Geographical Expansion

North America and Europe currently dominate the market, but the Asia-Pacific region is emerging as a significant player due to increasing diabetic populations and improving healthcare access. Countries like India and China are experiencing rapid growth in diabetes cases, driving the demand for effective treatment options[1].

Regulatory and Clinical Considerations

Dosage and Administration

Glyburide and Metformin Hydrochloride tablets are administered in divided doses, twice daily, with meals. The starting dose for patients not previously treated with either glyburide or metformin is typically 1.25 mg glyburide and 250 mg metformin HCl, with gradual dose increases based on glycemic control and tolerability[5].

Renal Impairment and Contraindications

The use of Glyburide and Metformin Hydrochloride is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m^2. Initiation in patients with an eGFR between 30 to 45 mL/minute/1.73 m^2 is not recommended, and the therapy should be discontinued if the eGFR falls below 30 mL/minute/1.73 m^2[5].

Key Takeaways

  • Growing Demand: The increasing global prevalence of Type 2 diabetes drives the demand for Glyburide and Metformin Hydrochloride.
  • Combination Therapy Efficacy: Glyburide and Metformin Hydrochloride offers superior glycemic control compared to monotherapy.
  • Generic Versions: The entry of generic manufacturers increases competition and affordability.
  • Regional Dynamics: Market dynamics vary across regions, with North America and Europe currently dominating and the Asia-Pacific region emerging as a significant player.
  • Technological Advancements: Innovations in drug formulation and delivery systems are expected to enhance efficacy and safety.
  • Regulatory Considerations: Strict guidelines regarding renal impairment and contraindications must be followed.

FAQs

What is the primary indication for Glyburide and Metformin Hydrochloride?

Glyburide and Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes[5].

How does the combination therapy compare to monotherapy in terms of efficacy?

The combination of Glyburide and Metformin Hydrochloride offers superior glycemic control, with a mean reduction in A1C levels of -2.27%, compared to -1.90% for glyburide and -1.53% for metformin monotherapy[2].

What are the key regions driving the demand for Glyburide and Metformin Hydrochloride?

North America, particularly the United States, and the Asia-Pacific region, especially India and China, are significant drivers of the market due to high diabetes prevalence and improving healthcare access[1].

What are the contraindications for using Glyburide and Metformin Hydrochloride?

The medication is contraindicated in patients with an eGFR below 30 mL/minute/1.73 m^2 and should not be initiated in patients with an eGFR between 30 to 45 mL/minute/1.73 m^2[5].

What technological advancements are expected to impact the market?

Technological innovations such as controlled-release formulations and personalized medicine approaches are expected to enhance the efficacy and safety profiles of Glyburide and Metformin Hydrochloride[1].

Sources

  1. Pmarketresearch: Glyburide and Metformin Hydrochloride Market.
  2. PubMed: Efficacy of glyburide/metformin tablets compared with metformin or glyburide monotherapy.
  3. Metabolism Journal: Pharmacotherapy of type 2 diabetes.
  4. Valuates Reports: Global Metformin Hydrochloride Market Research Report 2024.
  5. DailyMed: GLYBURIDE AND METFORMIN HYDROCHLORIDE tablet, film coated.

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