METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - Generic Drug Details

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.

Summary for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

International Patents:	113
US Patents:	4
Tradenames:	3
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	5
Clinical Trials:	155
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
DailyMed Link:	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

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

Sponsor	Phase
University of Minnesota	Phase 2
Nanjing First Hospital, Nanjing Medical University	Phase 3
Affiliated Hospital of Nantong University	Phase 1

See all METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE clinical trials

Pharmacology for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Drug Class	Biguanide Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists Peroxisome Proliferator-activated Receptor Activity

Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BG	Thiazolidinediones
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	090406-001	Feb 25, 2011		DISCN	No	No
Macleods Pharms Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	204802-002	Nov 5, 2015	AB	RX	No	No
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		Y
Macleods Pharms Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	204802-001	Nov 5, 2015	AB	RX	No	No
Teva Pharms Usa	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	091155-002	Mar 10, 2014	AB	RX	No	No
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005		DISCN	Yes	No	9,320,714		Y

Expired US Patents for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009	7,919,116
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	6,166,043
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	6,866,866
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005	6,166,042
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009	8,470,368
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	6,172,090

International Patents for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
New Zealand	539711	Solid preparation
Argentina	054238	COMPOSICION FARMACEUTICA QUE CONTIENE UNA BIGUANIDA Y UN DERIVADO DE TIAZOLIDINDIONA
Norway	20075427
South Korea	20110126761	NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE
Japan	5022893
Mexico	2007011824	FORMULACION FARMACEUTICA NOVEDOSA QUE CONTIENE UNA BIGUANIDA Y UN DERIVADO DE TIAZOLODINADIONA. (NOVEL PHARMACEUTICAL FORMULATION CONTAINING A BIGUANIDE AND A THIAZOLIDINEDIONE DERIVATIVE.)

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
2498758	PA2020003	Lithuania		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

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

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 ...