Pioglitazone hydrochloride - Generic Drug Details

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

Pioglitazone hydrochloride is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Accord Hlthcare, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Macleods Pharms Ltd, Norvium Bioscience, Nostrum Labs Inc, Prinston Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for pioglitazone hydrochloride. Twenty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for pioglitazone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	16
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	500
Patent Applications:	4,464
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pioglitazone hydrochloride
What excipients (inactive ingredients) are in pioglitazone hydrochloride?	pioglitazone hydrochloride excipients list
DailyMed Link:	pioglitazone hydrochloride at DailyMed

Recent Clinical Trials for pioglitazone hydrochloride

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

Sponsor	Phase
University of Minnesota	Phase 2
Wuhan Union Hospital, China	Phase 2
University of Campinas, Brazil	Phase 4

See all pioglitazone hydrochloride clinical trials

Generic filers with tentative approvals for PIOGLITAZONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		45MG	TABLET; ORAL
		30MG	TABLET; ORAL
		15MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pioglitazone hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for pioglitazone hydrochloride

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

US Patents and Regulatory Information for pioglitazone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	076798-002	Oct 26, 2012	AB	RX	No	No
Chartwell Rx	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	078383-001	Mar 12, 2013		DISCN	No	No
Accord Hlthcare	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	200044-001	Feb 13, 2013	AB	RX	No	No
Corepharma	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	210165-003	Jan 22, 2021	AB	RX	No	No
Chartwell Rx	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	076798-001	Oct 26, 2012	AB	RX	No	No
Teva Pharms Usa	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	077210-003	Jan 10, 2014	AB	RX	No	No
Norvium Bioscience	PIOGLITAZONE HYDROCHLORIDE	pioglitazone hydrochloride	TABLET;ORAL	076801-002	Aug 17, 2012		DISCN	No	No

Expired US Patents for pioglitazone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-001	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-003	Jul 15, 1999
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073-002	Jul 15, 1999

Pioglitazone hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pioglitazone Hydrochloride

Introduction

Pioglitazone hydrochloride, a thiazolidinedione (TZD) class of drug, is widely used in the management of type 2 diabetes mellitus. The market for this medication has been experiencing significant growth, driven by several key factors. Here, we delve into the market dynamics and financial trajectory of pioglitazone hydrochloride.

Market Size and Growth Projections

The global market for pioglitazone hydrochloride is substantial and growing. As of 2023, the market is valued at approximately USD 1.2 billion and is anticipated to reach USD 2.3 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 6%[4].

Drivers of Market Growth

Several factors are driving the growth of the pioglitazone hydrochloride market:

Rising Incidence of Type 2 Diabetes

The increasing prevalence of type 2 diabetes globally is a primary driver. As the population ages and lifestyles become more sedentary, the demand for effective antidiabetic medications like pioglitazone hydrochloride is on the rise[4].

Increasing Adoption of Oral Antidiabetic Medications

There is a growing preference for oral medications over injectables, which has boosted the demand for pioglitazone hydrochloride. This shift is driven by patient convenience and compliance[4].

Expanding Geriatric Population

The geriatric population, which is more susceptible to diabetes, is expanding. This demographic shift contributes significantly to the increasing demand for pioglitazone hydrochloride[4].

Regulatory Approvals and Technological Advancements

Regulatory approvals and technological advancements in drug formulations are also driving market growth. Ongoing research into the efficacy and safety of pioglitazone hydrochloride further supports its adoption[4].

Market Segmentation

The pioglitazone hydrochloride market is segmented based on several criteria:

By Type

The market is categorized into purity levels greater than 99% and less than 99%, which affects the pricing and application of the drug[1].

By Application

Pioglitazone hydrochloride is used in both chemical and medical applications, with the medical sector being the dominant segment due to its use in diabetes management[1].

By Region

Geographically, the market is segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. North America dominates the market due to high diabetes prevalence, robust healthcare expenditure, and favorable reimbursement policies. Europe follows closely, with significant adoption in countries like Germany, France, and the UK. The Asia-Pacific region represents a lucrative market opportunity due to rapid urbanization and an aging population[4].

Financial Trajectory

Revenue Projections

The market is expected to see sustained significant expansion from 2023 to 2033. The revenue is projected to grow from USD 1.2 billion in 2023 to USD 2.3 billion by 2033, indicating a robust financial trajectory[4].

Cost-Effectiveness Analysis

Studies have shown that pioglitazone hydrochloride is cost-effective in the long term. For instance, a study in Germany found that the incremental cost-effectiveness ratio (ICER) for pioglitazone treatment was €13,294 per quality-adjusted life year (QALY) gained, which is considered good value for money in the German healthcare setting[2].

Direct Medical Costs

Direct medical costs for pioglitazone treatment are marginally higher than for placebo but offer significant clinical benefits. The annual costs of study medication were calculated to be around €736.15 per patient for pioglitazone, based on data from the PROactive study[2].

Competitive Landscape

The pioglitazone hydrochloride market is highly competitive, with multiple pharmaceutical companies focusing on product differentiation, regulatory compliance, and market penetration strategies. Key players leverage their research and development capabilities to introduce new formulations and therapeutic combinations, enhancing treatment efficacy and patient compliance[4].

Future Outlook

The future outlook for the pioglitazone hydrochloride market is promising. Ongoing advancements in diabetes management, increasing healthcare investments, and expanding patient access to affordable medications will drive sustained growth. Trends such as personalized medicine, digital health integration, and preventive healthcare strategies will shape market dynamics and influence product development initiatives[4].

Market Opportunities

The market presents several opportunities for growth:

Expanding Indications

There is potential to expand the drug's indications beyond type 2 diabetes to include prediabetes and metabolic syndrome, addressing broader patient populations at risk of developing diabetes-related complications[4].

Strategic Collaborations

Strategic collaborations between pharmaceutical companies and research institutions facilitate clinical trials aimed at exploring new formulations, dosage regimens, and combination therapies to optimize treatment outcomes[4].

Geographic Expansion

Regions like Asia-Pacific, Latin America, and the Middle East & Africa offer moderate to high growth prospects due to improving healthcare infrastructure and rising awareness about diabetes prevention and management[4].

Key Takeaways

• Growing Market Size: The pioglitazone hydrochloride market is valued at USD 1.2 billion in 2023 and is expected to reach USD 2.3 billion by 2033.
• Drivers of Growth: Rising incidence of type 2 diabetes, increasing adoption of oral antidiabetic medications, and an expanding geriatric population.
• Cost-Effectiveness: Pioglitazone hydrochloride is considered cost-effective in the long term, with an ICER of €13,294 per QALY gained in the German setting.
• Competitive Landscape: The market is highly competitive, with key players focusing on product differentiation and regulatory compliance.
• Future Outlook: Promising growth driven by advancements in diabetes management and increasing healthcare investments.

FAQs

What is the current market size of pioglitazone hydrochloride?

The current market size of pioglitazone hydrochloride is approximately USD 1.2 billion as of 2023[4].

What is the projected growth rate of the pioglitazone hydrochloride market?

The market is expected to grow at a CAGR of 6% from 2023 to 2033[4].

Which regions dominate the pioglitazone hydrochloride market?

North America and Europe dominate the market, followed by the Asia-Pacific region[4].

Is pioglitazone hydrochloride cost-effective?

Yes, pioglitazone hydrochloride is considered cost-effective in the long term, with an ICER of €13,294 per QALY gained in the German setting[2].

What are the key drivers of the pioglitazone hydrochloride market?

The key drivers include the rising incidence of type 2 diabetes, increasing adoption of oral antidiabetic medications, and an expanding geriatric population[4].

Sources

1. Market Research Intellect: Pioglitazone Hydrochloride Market Size, Scope And Forecast Report.
2. NCBI: Cost-effectiveness of pioglitazone in type 2 diabetes patients.
3. P Market Research: Worldwide Pioglitazone HCL Market Research 2024 by Type, Application, Participants, and Countries Forecast to 2030.
4. Data Horizzon Research: Pioglitazone HCL Market Size, Growth and Analysis Report - 2033.
5. PubMed: Economic evaluation of pioglitazone hydrochloride in the treatment of type 2 diabetes.