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Last Updated: March 15, 2025

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of patent protection?

Metformin hydrochloride; pioglitazone hydrochloride is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Norvium Bioscience, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; pioglitazone hydrochloride has one hundred and thirteen patent family members in thirty-two countries.

Five suppliers are listed for this compound.

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

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

SponsorPhase
University of MinnesotaPhase 2
Nanjing First Hospital, Nanjing Medical UniversityPhase 3
Affiliated Hospital of Nantong UniversityPhase 1

See all METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE clinical trials

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ACTOPLUS MET XR Extended-release Tablets metformin hydrochloride; pioglitazone hydrochloride 15 mg/1000 mg and 30 mg/1000 mg 022024 1 2011-09-23

US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-001 Aug 29, 2005 DISCN Yes No 9,320,714 ⤷  Try for Free Y ⤷  Try for Free
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-002 Aug 29, 2005 AB RX Yes Yes 9,101,660 ⤷  Try for Free Y ⤷  Try for Free
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No 7,785,627 ⤷  Try for Free Y ⤷  Try for Free
Teva Pharms Usa PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 091155-002 Mar 10, 2014 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 091273-002 Apr 16, 2013 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aurobindo Pharma Ltd PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 200823-001 Feb 13, 2013 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Expired US Patents for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 9,060,941 ⤷  Try for Free
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 6,166,043 ⤷  Try for Free
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 8,470,368 ⤷  Try for Free
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 8,475,841 ⤷  Try for Free
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 6,866,866 ⤷  Try for Free
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 4,687,777 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 6 of 6 entries

International Patents for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

CountryPatent NumberTitleEstimated Expiration
Argentina 054238 COMPOSICION FARMACEUTICA QUE CONTIENE UNA BIGUANIDA Y UN DERIVADO DE TIAZOLIDINDIONA ⤷  Try for Free
European Patent Office 1539144 NOUVELLE PREPARATION PHARMACEUTIQUE CONTENANT UN BIGUANIDE ET UN DERIVE DE LA THIAZOLIDINEDIONE (MULTISTAGE FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE) ⤷  Try for Free
Georgia, Republic of P20104936 NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE ⤷  Try for Free
Norway 332993 ⤷  Try for Free
Spain 2593469 ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2008100240 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1412357 122008000046 Germany ⤷  Try for Free PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1506211 132014902277722 Italy ⤷  Try for Free PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
2498758 132020000000034 Italy ⤷  Try for Free PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
1532149 C300569 Netherlands ⤷  Try for Free PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1412357 PA2008013,C1412357 Lithuania ⤷  Try for Free PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
2498758 PA2020003 Lithuania ⤷  Try for Free PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory for Metformin-Pioglitazone

Introduction

The combination of metformin and pioglitazone, commonly known as Metformin-Pioglitazone, is a crucial treatment for type 2 diabetes. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this medication.

Market Size and Forecast

The Metformin-Pioglitazone market has been experiencing steady growth. As of 2020, the market size was valued at USD 811.75 million and is projected 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

Several factors are driving the growth of the Metformin-Pioglitazone market:

Rising Prevalence of Type 2 Diabetes

The increasing prevalence of type 2 diabetes globally is a significant driver. It is estimated that the number of people with diabetes will rise from 36 million by 2030 to 81 million by 2045, which will increase the demand for Metformin-Pioglitazone[1].

Growing Approvals for Oral Antidiabetic Drugs

The rising number of approvals for oral antidiabetic drugs highlights the increasing adoption of these medications, further boosting the demand for Metformin-Pioglitazone[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 segmented into two main applications:

  • Drug Store
  • Hospital

Drug stores accounted for the largest market share in 2020 and are projected to grow at the highest CAGR during the forecast period. Hospitals were the second-largest market in 2020[1].

Regional Analysis

Geographically, the market is classified into North America, Europe, Asia Pacific, and the rest of the world. Asia Pacific accounted for the largest market share, while North America was the second-largest market in 2020. Significant increases have been observed in East Asia and South Asia, where the highest number of people with diabetes reside[1].

Key Players

The competitive landscape of the Metformin-Pioglitazone market includes major players such as:

  • Mylan
  • Teva Pharmaceutical Industries Ltd
  • Takeda Pharmaceuticals
  • Sandoz
  • Aurobindo Pharma
  • Macleods
  • Torrent Pharmaceuticals

These companies are actively involved in strategic developments, such as acquisitions and mergers, to strengthen their market positions[1].

Cost-Effectiveness Analysis

A cost-effectiveness analysis comparing pioglitazone plus metformin with rosiglitazone plus metformin revealed that pioglitazone plus metformin is a dominant long-term treatment strategy. This is due to modest improvements in quality-adjusted life-years (QALYs) and significant savings in total complication costs, particularly for cardiovascular diseases[2].

Clinical Efficacy

Clinical studies have shown that the combination of pioglitazone and metformin significantly improves glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) levels. It also has positive effects on serum lipid levels without evidence of drug-induced hepatotoxicity[5].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

  • Side Effects and FDA Black Box Warning The Metformin-Pioglitazone medication comes with a black box warning from the FDA, highlighting serious adverse events such as injuries and deaths. This could discourage some patients from using the medication, potentially hampering market growth[1].

Financial Trajectory

Revenue Projections

The market is expected to grow steadily, with revenue projected to reach USD 1,127.78 million by 2028. This growth is driven by the increasing demand for effective treatments for type 2 diabetes[1].

Investment and Acquisitions

Companies in the market are actively involved in strategic investments and acquisitions. For example, Sandoz acquired GSK’s cephalosporin antibiotics business in October 2021, and Mylan acquired Aspen Pharmacare’s thrombosis business-related intellectual property and commercialization rights in Europe in September 2020[1].

Geographical Market Dynamics

Asia Pacific

The Asia Pacific region, particularly East Asia and South Asia, has the highest number of people with diabetes. Countries like Indonesia, the Philippines, Thailand, and Vietnam contribute significantly to the market due to their large populations and high diabetes rates[1].

North America and Europe

These regions currently dominate the market due to advanced healthcare infrastructure and high adoption rates of oral antidiabetic drugs. However, the growth in these regions is expected to be slower compared to the Asia Pacific region[3].

Key Takeaways

  • The Metformin-Pioglitazone market is growing due to the rising prevalence of type 2 diabetes and increasing approvals for oral antidiabetic drugs.
  • The market is segmented into different types and applications, with drug stores being the largest market segment.
  • Asia Pacific is the largest market region, driven by high diabetes rates in countries like China and India.
  • Key players are involved in strategic developments to enhance their market positions.
  • Despite growth, the market faces challenges from side effects and FDA black box warnings.

FAQs

Q: What is the projected market size of Metformin-Pioglitazone by 2028?

A: The market size 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 dominates the Metformin-Pioglitazone market?

A: The Asia Pacific region currently dominates the market, with significant contributions from East Asia and South Asia[1].

Q: What are the main types of Metformin-Pioglitazone tablets available?

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

Q: Which companies are key players in the Metformin-Pioglitazone market?

A: Key players include Mylan, Teva Pharmaceutical Industries Ltd, Takeda Pharmaceuticals, Sandoz, Aurobindo Pharma, Macleods, and Torrent Pharmaceuticals[1].

Q: What are the significant challenges facing the Metformin-Pioglitazone market?

A: The market faces challenges from side effects and the FDA black box warning, which could discourage some patients from using the medication[1].

Sources

  1. Verified Market Research: Metformin-Pioglitazone Market Size, Share, Trends, Scope & Forecast.
  2. PubMed: A cost-effectiveness analysis of pioglitazone plus metformin ...
  3. PMarketResearch: Worldwide Metformin-Pioglitazone Market Research 2024 by Type ...
  4. Market Research Intellect: Global Metformin-Pioglitazone Market Size And Forecast.
  5. PubMed: Pioglitazone hydrochloride in combination with metformin ...

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.