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Last Updated: December 22, 2024

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Drug Patent Profile


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

Saxagliptin And Metformin Hydrochloride is a drug marketed by Mylan and Sun Pharm and is included in two NDAs.

The generic ingredient in SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

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

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SponsorPhase
Sabyasachi SenPhase 4
Shenzhen Sixth People's HospitalPhase 4
Dongguan Kanghua HospitalPhase 4

See all SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

US Patents and Regulatory Information for SAXAGLIPTIN 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
Mylan SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205981-002 Jul 31, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 206081-002 Jul 31, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205981-003 Jul 31, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205981-001 Jul 31, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 206081-001 Jul 31, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 206081-003 Jul 31, 2023 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

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Saxagliptin and Metformin Hydrochloride: Market Dynamics and Financial Trajectory

Introduction

Saxagliptin and metformin hydrochloride, commonly known by the brand name KOMBIGLYZE XR, is a combination therapy used to treat type 2 diabetes mellitus. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this medication.

Market Overview

The global market for saxagliptin, including its combination with metformin, is projected to grow significantly due to several key factors.

Increasing Prevalence of Diabetes

The rising incidence of type 2 diabetes, driven by factors such as changing lifestyles, reduced physical exercise, and increasing obesity, is a major driver for the saxagliptin market. As the global population ages and adopts more sedentary lifestyles, the demand for effective diabetes treatments is expected to increase[4].

Market Size and Growth

The saxagliptin market is estimated to reach $255 million by 2027, growing at a CAGR of 4.17% during the forecast period 2022-2027. This growth is fueled by the increasing need for effective diabetes management and the integration of saxagliptin into treatment regimens[1].

Distribution Channels

The market for saxagliptin and metformin hydrochloride is segmented by distribution channels, which include hospital pharmacies, retail pharmacies, and online pharmacies.

Online Pharmacies

Online pharmacies have seen significant growth, particularly during the COVID-19 pandemic, due to the ease of use and convenience they offer. This segment held the largest market share in 2021 and continues to grow as patients prefer the comfort of purchasing medications from home[1].

Hospital Pharmacies

Hospital pharmacies are also expected to grow rapidly, with a CAGR of 4.9% during the forecast period 2022-2027, as healthcare systems return to pre-pandemic norms and hospital visits increase[1].

Geographic Segmentation

Geographically, the saxagliptin market is segmented into North America, Europe, Asia-Pacific, South America, and the Rest of the World.

North America

North America accounted for the highest revenue share in 2021, driven by the increasing population of elderly individuals and the high prevalence of type 2 diabetes in the region. Government financing and healthcare spending on R&D are additional factors propelling market growth in this region[1].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing segment during the forecast period, driven by the expanding population in countries like India and China, along with increasing government financing and healthcare spending[1].

Cost-Effectiveness and Economic Impact

Comparative Cost-Effectiveness

Studies have shown that saxagliptin plus metformin (SAXA+MET) is a cost-effective treatment alternative compared to acarbose plus metformin (ACAR+MET) in patients with type 2 diabetes. SAXA+MET predicted lower incidences of cardiovascular events, hypoglycemia, and fatal events, resulting in lower total costs and a higher quality-adjusted life-years (QALYs) gain[2].

Annual Treatment Costs

The annual treatment cost for saxagliptin (5 mg) plus metformin is estimated to be around ¥5,209.03 in China, which is lower than the cost for acarbose plus metformin. This cost-effectiveness makes saxagliptin a preferred option for long-term diabetes management[2].

Clinical Efficacy and Safety

Glycemic Control

KOMBIGLYZE XR has been shown to deliver strong glycemic control in clinical trials. Studies have demonstrated significant reductions in HbA1c levels, fasting plasma glucose (FPG), and postprandial glucose (PPG) compared to metformin alone or placebo[5].

Adverse Events

While saxagliptin and metformin hydrochloride are generally well-tolerated, common adverse reactions include headache, nasopharyngitis, and upper respiratory tract infections. However, the incidence of hypoglycemia is low, and the drug confers a low risk of cardiovascular events[5].

Regulatory and Safety Considerations

FDA Approval

KOMBIGLYZE XR was approved by the FDA based on two Phase III clinical trials and bioequivalence studies. The drug is contraindicated in patients with renal impairment, metabolic acidosis, and hypersensitivity to metformin[5].

Market Drivers

Increasing Government Financing

Government financing and increased spending on healthcare R&D are significant drivers for the saxagliptin market. These investments support the development and adoption of new diabetes therapies, including saxagliptin and metformin hydrochloride[1].

Innovative R&D Activities

Innovative research and development activities in the field of diabetes therapeutics are propelling the growth of the saxagliptin market. New formulations and combination therapies are being developed to improve patient outcomes and compliance[1].

Market Restraints

Adverse Effects

Despite its benefits, saxagliptin can cause adverse effects such as upper respiratory tract infections, urinary tract infections, and headaches. These side effects can hamper market growth if not managed effectively[4].

Regulatory Framework

A strict regulatory framework for diabetic drugs can also restrain market growth. Manufacturers must comply with stringent regulations, which can slow down the approval and launch of new products[4].

Emerging Markets

Asia-Pacific and LAMEA

Emerging economies in the Asia-Pacific and LAMEA regions offer significant growth opportunities for the saxagliptin market. Increasing healthcare spending and government financing in these regions are expected to drive market growth in the coming years[4].

Key Takeaways

  • The saxagliptin market is projected to reach $255 million by 2027, growing at a CAGR of 4.17% during the forecast period 2022-2027.
  • Online pharmacies and hospital pharmacies are key distribution channels driving market growth.
  • North America and the Asia-Pacific region are significant geographic segments, with the latter expected to grow the fastest.
  • Saxagliptin plus metformin is a cost-effective treatment alternative with lower total costs and higher QALYs gain.
  • Clinical trials have demonstrated the efficacy and safety of KOMBIGLYZE XR in achieving strong glycemic control.

FAQs

What is the primary use of saxagliptin and metformin hydrochloride?

Saxagliptin and metformin hydrochloride, known by the brand name KOMBIGLYZE XR, are used to treat type 2 diabetes mellitus in adults.

What are the key drivers of the saxagliptin market?

The key drivers include the increasing prevalence of diabetes, government financing, innovative R&D activities, and the growing need for effective diabetes management.

Which distribution channel holds the largest market share for saxagliptin?

Online pharmacies currently hold the largest market share due to the convenience and ease of use they offer, especially during the COVID-19 pandemic.

What are the common adverse reactions associated with saxagliptin and metformin hydrochloride?

Common adverse reactions include headache, nasopharyngitis, upper respiratory tract infections, and urinary tract infections.

Is saxagliptin plus metformin a cost-effective treatment option?

Yes, studies have shown that saxagliptin plus metformin is a cost-effective treatment alternative compared to other combinations, with lower total costs and a higher QALYs gain.

Sources

  1. IndustryARC, "Saxagliptin Market - Forecast(2024 - 2030) - IndustryARC"
  2. PMC, "Cost-Effectiveness of Saxagliptin versus Acarbose as Second-Line Therapy for Patients with Type 2 Diabetes Mellitus in China"
  3. Canada.ca, "Market Intelligence Report: Antidiabetic Drugs, 2012-2021"
  4. Allied Market Research, "Saxagliptin Market Size, Share and Trends | Forecast by 2019 - 2026"
  5. BMS News, "KOMBIGLYZE™ XR (Saxagliptin and Metformin HCl Extended-Release) Tablets Approved in the U.S. for the Treatment of Type 2 Diabetes Mellitus in Adults"

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