Metformin hydrochloride; pioglitazone hydrochloride - Generic Drug Details

What are the generic drug sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of freedom to operate?

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
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	AB	RX	Yes	Yes			Y
Macleods Pharms Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	204802-002	Nov 5, 2015	AB	RX	No	No
Macleods Pharms Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	204802-001	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			Y
Aurobindo Pharma Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	200823-001	Feb 13, 2013	AB	RX	No	No
Aurobindo Pharma Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	200823-002	Feb 13, 2013	AB	RX	No	No

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
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005

International Patents for metformin hydrochloride; pioglitazone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2011202162	Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
China	101675929	Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Japan	4718465
Japan	5881962
European Patent Office	2604266	Nouvelle formulation pharmaceutique contenant un biguanide et dérivé de thiazolidinedione (Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative)
South Korea	20080005359	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
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1261586	15/2012	Austria		PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1412357	132008901682802	Italy		PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408
2498758	2020C/509	Belgium		PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1412357	C 2008 016	Romania		PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408

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 ...