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Last Updated: December 22, 2024

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE Drug Patent Profile


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

Pioglitazone Hydrochloride And Metformin Hydrochloride is a drug marketed by Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Norvium Bioscience, Teva Pharms Usa, and Torrent Pharms Ltd. and is included in six NDAs.

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

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Summary for PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Drug patent expirations by year for PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
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SponsorPhase
University of MinnesotaPhase 2
Nanjing First Hospital, Nanjing Medical UniversityPhase 3
Affiliated Hospital of Nantong UniversityPhase 1

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US Patents and Regulatory Information for PIOGLITAZONE HYDROCHLORIDE 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
Aurobindo Pharma Ltd PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 200823-001 Feb 13, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 090406-001 Feb 25, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 091273-002 Apr 16, 2013 DISCN 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

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pioglitazone Hydrochloride and Metformin Hydrochloride

Introduction

Pioglitazone hydrochloride and metformin hydrochloride, commonly combined in medications like Actoplus Met, are crucial in the management of type 2 diabetes mellitus. This combination therapy has been gaining traction due to its efficacy in controlling blood sugar levels and its potential long-term health benefits.

Market Size and Forecast

The global market for metformin-pioglitazone is projected to experience significant growth. As of 2020, the market size was valued at USD 811.75 million and is expected to reach USD 1,127.78 million by 2028, growing at a Compound Annual Growth Rate (CAGR) of 4.37% from 2021 to 2028[1].

Drivers of Market Growth

Rising Prevalence of Type 2 Diabetes

The increasing global prevalence of type 2 diabetes is a major driver of the market. The number of people with diabetes is estimated to rise from 415 million in 2015 to 36 million by 2030 and 81 million by 2045, significantly boosting the demand for metformin-pioglitazone[1].

Growing Approvals for Oral Antidiabetic Drugs

The growing number of approvals for oral antidiabetic drugs further enhances the adoption of metformin-pioglitazone, contributing to market growth[1].

Regional Demand

Asia Pacific accounts for the largest market share, followed by North America. The high prevalence of diabetes in regions like East Asia and South Asia, particularly in countries such as Indonesia, the Philippines, Thailand, and Vietnam, drives the demand for this medication[1].

Market Segmentation

By Type

The market is segmented into two main types based on the dosage:

  • Tablets: 15 Mg Pioglitazone/1000 Mg Metformin Hcl
  • Tablets: 30 Mg Pioglitazone/1000 Mg Metformin Hcl

The 15 mg pioglitazone/1000 mg metformin HCl tablets accounted for the largest market share in 2020 and are projected to grow at the highest CAGR of 4.65% during the forecast period[1].

By Application

The market is also segmented by application, including hospitals, drug stores, and other healthcare facilities. These segments are crucial as they reflect the end-use of the medication and the channels through which it is distributed[5].

Cost-Effectiveness and Economic Impact

Long-Term Cost-Effectiveness

Studies have shown that pioglitazone plus metformin is a cost-effective treatment strategy compared to rosiglitazone plus metformin. Over patients' lifetimes, total direct medical costs are projected to be marginally lower with pioglitazone plus metformin, largely due to reduced cardiovascular disease (CVD) complication costs[2].

Quality-Adjusted Life Years (QALYs)

Pioglitazone plus metformin results in a modest improvement in QALYs compared to rosiglitazone plus metformin. This combination is found to be a dominant long-term treatment strategy in the US, driven by the combination of modest differences in QALYs and savings in total complication costs over 35 years[2].

Challenges and Restraints

Side Effects and FDA Black Box Warning

The medication comes with a black box warning from the FDA, highlighting serious adverse events such as injuries and deaths. This warning can discourage patients from using the medication, potentially hampering market growth[1].

Regulatory Frameworks

Stringent regulatory frameworks and the potential for side effects like weight gain and fluid retention also pose challenges to the market. Additionally, competition from newer, alternative diabetes treatments can impede growth[3].

Key Players and Competitive Landscape

Major players in the metformin-pioglitazone market include Mylan, Teva Pharmaceutical Industries Ltd, Takeda Pharmaceuticals, Sandoz, Aurobindo Pharma, Macleods, and Torrent Pharmaceuticals. These companies are actively involved in strategic acquisitions and partnerships to strengthen their market positions[1].

Regional Analysis

Asia Pacific

Asia Pacific is the largest market for metformin-pioglitazone, driven by the high prevalence of diabetes in countries like China, India, and other Southeast Asian nations. The Western Pacific region, including countries like Indonesia and the Philippines, also contributes significantly to the market[1].

North America

North America is the second-largest market, with significant demand driven by the high incidence of type 2 diabetes in the region[1].

Future Outlook and Opportunities

Emerging Economies

Emerging economies offer untapped potential for market expansion due to rising healthcare expenditures and improving healthcare infrastructures. These regions are expected to drive future growth as awareness about disease management protocols increases among patients and healthcare professionals[3].

Chronic Disease Management

The increasing focus on chronic disease management programs in healthcare systems presents opportunities for the metformin-pioglitazone market. As the global population ages and becomes more susceptible to chronic ailments, the demand for effective antidiabetic medications is expected to rise[3].

Key Takeaways

  • The metformin-pioglitazone market is projected to grow significantly due to the rising prevalence of type 2 diabetes.
  • The market is driven by growing approvals for oral antidiabetic drugs and high demand in regions like Asia Pacific.
  • Cost-effectiveness studies indicate that pioglitazone plus metformin is a dominant long-term treatment strategy.
  • Challenges include FDA black box warnings, side effects, and competition from alternative treatments.
  • Emerging economies and chronic disease management programs offer future growth opportunities.

FAQs

Q: What is the projected market size of the metformin-pioglitazone market by 2028?

A: The market is projected to reach USD 1,127.78 million by 2028, growing at a CAGR of 4.37% from 2021 to 2028[1].

Q: Which region accounts for the largest market share for metformin-pioglitazone?

A: Asia Pacific accounts for the largest market share, followed by North America[1].

Q: What are the main types of metformin-pioglitazone tablets available in the market?

A: The main types are Tablets: 15 Mg Pioglitazone/1000 Mg Metformin Hcl and Tablets: 30 Mg Pioglitazone/1000 Mg Metformin Hcl[1].

Q: What are the key drivers of the metformin-pioglitazone market?

A: The key drivers include the rising prevalence of type 2 diabetes, growing approvals for oral antidiabetic drugs, and high demand in regions like Asia Pacific[1].

Q: What are the potential challenges to the growth of the metformin-pioglitazone market?

A: Challenges include FDA black box warnings, side effects like weight gain and fluid retention, and competition from newer, alternative diabetes treatments[1][3].

Sources

  1. Verified Market Research - Metformin-Pioglitazon Market Size, Share, Trends, Scope & Forecast
  2. PubMed - A cost-effectiveness analysis of pioglitazone plus metformin ...
  3. 360 Research Reports - Pioglitazone Hydrochloride Tablets Market Size 2025-2030
  4. NIHR - Effectiveness of pioglitazone and rosiglitazone in the treatment of ...
  5. Market Research Intellect - Global Metformin-Pioglitazone Market Size And Forecast

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