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Last Updated: December 23, 2024

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SAXAGLIPTIN Drug Patent Profile


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

Saxagliptin is a drug marketed by Amneal, Aurobindo Pharma, Glenmark Pharms Ltd, Mylan, and Sun Pharm. and is included in seven NDAs.

The generic ingredient in SAXAGLIPTIN 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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Drug patent expirations by year for SAXAGLIPTIN
Recent Clinical Trials for SAXAGLIPTIN

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SponsorPhase
University of Erlangen-Nürnberg Medical SchoolPhase 4
Ain Shams UniversityN/A
Sabyasachi SenPhase 3

See all SAXAGLIPTIN clinical trials

Pharmacology for SAXAGLIPTIN

US Patents and Regulatory Information for SAXAGLIPTIN

SAXAGLIPTIN is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205941-001 Jul 31, 2023 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205980-001 Jul 31, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma SAXAGLIPTIN saxagliptin hydrochloride TABLET;ORAL 205972-002 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Saxagliptin

Introduction to Saxagliptin

Saxagliptin is a medication used to treat type 2 diabetes mellitus. It works by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which helps to increase the levels of incretin hormones, enhancing the release of insulin and decreasing the production of glucose in the liver. Here’s a detailed look at the market dynamics and financial trajectory of saxagliptin.

Market Size and Growth

The global saxagliptin market is projected to experience significant growth over the forecast period. According to market reports, the market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2032, reaching a substantial market size by the end of the forecast period[1][4].

Key Drivers of the Market

Several factors are driving the growth of the saxagliptin market:

  • Rising Prevalence of Diabetes: The increasing cases of type 2 diabetes globally, particularly in regions like North America and Europe, are a major driver. The Asia Pacific region, especially countries like China and India, is also expected to contribute significantly to this growth due to a large and growing population[1][4].
  • Increasing Healthcare Expenditure: Rising healthcare spending and government funding for diabetes treatment are boosting the market. The growing awareness of diabetes and the need for effective treatments are further fueling this growth[1][4].
  • Sedentary Lifestyle and Obesity: The increasing prevalence of sedentary lifestyles and obesity, which are risk factors for type 2 diabetes, are also driving the demand for saxagliptin[1][4].
  • Innovations in Diabetes Therapeutics: Continuous research and development in diabetes treatments are expected to propel the market forward. New formulations and delivery methods are likely to enhance the market's growth potential[4].

Geographical Analysis

The saxagliptin market is segmented geographically into several key regions:

  • North America: This region holds the largest market share due to the high prevalence of type 2 diabetes and a significant elderly population. The region is expected to continue dominating the market due to increasing healthcare spending and government financing for diabetes research and treatment[1][4].
  • Europe: Europe is another significant market for saxagliptin, driven by similar factors such as an ageing population and rising healthcare expenditure[1][4].
  • Asia Pacific: This region is expected to witness robust growth, driven by the large and growing populations in countries like China and India, along with increasing government funding and healthcare spending[1][4].

Distribution Channels

The market is segmented by distribution channels, which include:

  • Hospital Pharmacies: These are expected to grow at a CAGR of 4.9% during the forecast period as life returns to pre-pandemic normalcy. Hospital pharmacies are crucial for the sale of dipeptidyl peptidase-4 inhibitors like saxagliptin[4].
  • Retail Pharmacies: These continue to be a significant channel for the distribution of saxagliptin.
  • Online Pharmacies: The online segment saw significant growth during the COVID-19 pandemic due to lockdowns and stay-at-home restrictions. This segment is expected to continue growing due to its convenience and ease of use[4].

Dosage and Product Segments

The market is also segmented by dosage and product purity:

  • Dosage: The 2.5 mg and 5 mg dosages are the leading segments. The 5 mg segment is expected to grow with the fastest CAGR due to the increasing application of Onglyza 5 mg film-coated tablets[4].
  • Product Purity: The market is segmented into products with purity levels of 98% and 99%. These segments are analyzed based on their market size and growth projections[3].

Challenges and Restraints

Despite the positive growth trajectory, the saxagliptin market faces several challenges:

  • Stringent Regulatory Approvals: The approval process for drugs is stringent, which can slow down market growth.
  • Availability of Substitutes: The presence of alternative treatments for diabetes can act as a restraint.
  • Side Effects: Saxagliptin may have side effects such as stroke and heart attack, which can hamper market growth[1][4].

Key Players and Competitive Landscape

The market is dominated by several key players, including:

  • AstraZeneca plc.: A major player in the saxagliptin market, known for its product Onglyza.
  • Wellona Pharma: Another significant player contributing to the market growth[1][4].

These companies are involved in various competitive strategies such as mergers, acquisitions, and investments to expand their market share.

Financial Performance and Outlook

The financial performance of the saxagliptin market is closely tied to the overall pharmaceutical industry trends. Companies like AstraZeneca have reported strong revenue growth in their therapeutic areas, including diabetes treatments. For instance, AstraZeneca's total revenue increased by 25% in 2022, driven by growth in all therapy areas, including the addition of Alexion[2].

Revenue Projections

The market is expected to reach significant revenue by the end of the forecast period. For example, the saxagliptin market size is estimated to reach $255 million by 2027, growing at a CAGR of 4.17% from 2022 to 2027[4].

Innovations and R&D

Continuous research and development in diabetes therapeutics are crucial for the growth of the saxagliptin market. Innovations in drug formulations, delivery methods, and combination therapies are expected to drive market expansion. Companies are investing heavily in R&D to develop more effective and safer treatments for type 2 diabetes[4].

Government Funding and Healthcare Spending

Government funding and increasing healthcare expenditure are significant drivers of the saxagliptin market. Governments are investing more in diabetes research and treatment, which is boosting the demand for saxagliptin and other diabetes medications[1][4].

Consumer Insights and Market Trends

Consumer insights indicate a growing awareness of diabetes and the need for effective treatments. The market trends suggest a shift towards more convenient and accessible distribution channels, such as online pharmacies, which have seen significant growth during the pandemic[4].

Key Takeaways

  • The global saxagliptin market is expected to grow at a CAGR of 4% from 2024 to 2032.
  • The market is driven by the rising prevalence of type 2 diabetes, increasing healthcare expenditure, and government funding.
  • North America and Europe are significant markets, with the Asia Pacific region expected to witness robust growth.
  • Hospital pharmacies and online pharmacies are key distribution channels.
  • The 5 mg dosage segment is expected to grow with the fastest CAGR.
  • Stringent regulatory approvals and the availability of substitutes are major restraints.

FAQs

What is saxagliptin used for?

Saxagliptin is used to treat type 2 diabetes mellitus by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which helps to increase the levels of incretin hormones, enhancing the release of insulin and decreasing the production of glucose in the liver.

What are the key drivers of the saxagliptin market?

The key drivers include the rising prevalence of type 2 diabetes, increasing healthcare expenditure, government funding, sedentary lifestyles, and obesity.

Which regions are significant for the saxagliptin market?

North America and Europe are currently the significant markets, with the Asia Pacific region expected to witness robust growth in the forecast period.

What are the major distribution channels for saxagliptin?

The major distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies, with online pharmacies seeing significant growth during the COVID-19 pandemic.

What are the potential challenges for the saxagliptin market?

The market faces challenges such as stringent regulatory approvals, the availability of substitutes, and potential side effects like stroke and heart attack.

Cited Sources

  1. Expert Market Research: Global Saxagliptin Market Report and Forecast 2024-2032.
  2. AstraZeneca: Full year and Q4 2022 results announcement.
  3. Market Research Intellect: Saxagliptin API Market Size And Forecast.
  4. IndustryARC: Saxagliptin Market - Forecast(2024 - 2030).

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