Alogliptin benzoate; pioglitazone hydrochloride - Generic Drug Details

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

Alogliptin benzoate; pioglitazone hydrochloride is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate; pioglitazone hydrochloride has one hundred and one patent family members in forty-two countries.

Two suppliers are listed for this compound.

Summary for alogliptin benzoate; pioglitazone hydrochloride

International Patents:	101
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alogliptin benzoate; pioglitazone hydrochloride
DailyMed Link:	alogliptin benzoate; pioglitazone hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for alogliptin benzoate; pioglitazone hydrochloride

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for alogliptin benzoate; pioglitazone hydrochloride

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

Sponsor	Phase
Yonsei University	Phase 4
Celltrion Pharm, Inc.	Phase 4
Takeda	Phase 4

See all alogliptin benzoate; pioglitazone hydrochloride clinical trials

Pharmacology for alogliptin benzoate; pioglitazone hydrochloride

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

Anatomical Therapeutic Chemical (ATC) Classes for alogliptin benzoate; pioglitazone hydrochloride

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

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for alogliptin benzoate; 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	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes				Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013		RX	Yes	No			Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013		DISCN	Yes	No			Y

Expired US Patents for alogliptin benzoate; pioglitazone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013

International Patents for alogliptin benzoate; pioglitazone hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Africa	200607252	Dipeptidyl peptidase inhibitors
Norway	20064669
Taiwan	200531695	Dipeptidyl peptidase inhibitors

Supplementary Protection Certificates for alogliptin benzoate; pioglitazone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	C 2014 011	Romania		PRODUCT NAME: ALOGLIPTIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/844/001 - EU/1/13/844/027; DATE OF NATIONAL AUTHORISATION: 20130919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/844/001 - EU/1/13/844/027; DATE OF FIRST AUTHORISATION IN EEA: 20130919
1084705	SPC/GB14/083	United Kingdom		PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1586571	92374	Luxembourg		PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923

Alogliptin benzoate; pioglitazone hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alogliptin Benzoate and Pioglitazone Hydrochloride

Introduction to Alogliptin Benzoate and Pioglitazone Hydrochloride

Alogliptin benzoate and pioglitazone hydrochloride are two antihyperglycemic drugs commonly used in the management of type 2 diabetes mellitus. Alogliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, while pioglitazone is a thiazolidinedione. When combined, these drugs offer a synergistic approach to glycemic control.

Global Prevalence of Type 2 Diabetes and Market Demand

The escalating global prevalence of type 2 diabetes is a significant driver of the market for alogliptin benzoate and pioglitazone hydrochloride. According to the International Diabetes Federation, the number of adults living with diabetes is projected to rise from 463 million in 2019 to 700 million by 2045. This surge in diabetes cases, attributed to factors such as sedentary lifestyles, unhealthy dietary habits, and increasing obesity rates, has created an urgent need for effective and well-tolerated treatment options[4].

Market Size and Growth

The Alogliptin Benzoate Tablet Market is expected to witness exponential growth at a significant CAGR during the forecast period from 2024. This growth is driven by the increasing global prevalence of type 2 diabetes, the favorable safety profile of alogliptin, and its convenience of once-daily oral administration. The market is also propelled by regulatory approvals in major markets and the growing trend towards combination therapies involving alogliptin[4].

Key Market Highlights

• Increasing Global Prevalence of Type 2 Diabetes: The rising number of diabetes cases worldwide is a primary driver of market growth.
• Favorable Safety Profile and Once-Daily Dosing: Alogliptin's effectiveness in improving glycemic control with a lower risk of hypoglycemia and its convenient dosing schedule enhance its adoption.
• Regulatory Approvals: Approvals in major markets have boosted market penetration for alogliptin benzoate tablets.
• Combination Therapies: The use of alogliptin in combination with other antidiabetic medications, such as pioglitazone, is a growing trend.
• Emerging Economies: Rising demand in emerging economies like China, India, and South Korea, driven by improving healthcare infrastructure and increasing awareness of modern diabetes treatments[4].

Regional Market Dynamics

Asia-Pacific Region

The Asia-Pacific region, particularly Japan, where alogliptin was first developed and approved, remains a key market. Countries like China, India, and South Korea are experiencing significant market growth due to large patient populations and evolving treatment paradigms. However, the market in this region faces challenges related to pricing pressures and varying regulatory requirements[4].

Latin America

Latin America offers considerable growth potential, with countries like Brazil and Mexico leading the way. The region is characterized by a growing middle class with increasing access to advanced healthcare treatments. However, market penetration varies significantly across different countries, influenced by factors such as government healthcare policies and local pharmaceutical industry dynamics[4].

Financial Trajectory

The financial trajectory of the alogliptin benzoate and pioglitazone hydrochloride market is promising, driven by several key factors:

• Revenue Growth: The market is projected to experience significant revenue growth due to the increasing demand for effective antidiabetic medications.
• Market Expansion: The expansion of indications to include cardiovascular risk reduction in diabetic patients further enhances the financial outlook.
• Strategic Collaborations: Strategic collaborations and partnerships among pharmaceutical companies are shaping market dynamics and contributing to financial growth[4].

Challenges and Opportunities

Challenges

• Generic Competition: The entry of generic alternatives in key markets is expected to lead to price pressures.
• Regulatory Requirements: Varying regulatory requirements and the need for ongoing clinical trials to address safety concerns, such as pancreatitis and liver toxicity, pose challenges[2][5].
• Competition from Newer Drug Classes: The market faces competition from newer drug classes, which could impact the adoption of alogliptin benzoate and pioglitazone hydrochloride.

Opportunities

• Personalized Medicine: The increasing focus on personalized medicine in diabetes care presents an opportunity for more targeted use of alogliptin in specific patient subgroups.
• Technological Advancements: Integration of digital health technologies in diabetes management can enhance the efficacy and compliance of treatment regimens involving alogliptin and pioglitazone.
• Emerging Markets: The growing middle class in emerging economies with increasing access to advanced healthcare treatments offers significant growth opportunities[4].

Safety and Efficacy Considerations

The safety and efficacy of alogliptin benzoate and pioglitazone hydrochloride are crucial for their market success. Key safety considerations include:

• Hepatic Effects: Postmarketing reports of hepatic failure, sometimes fatal, necessitate caution in patients with liver disease[2].
• Edema and Fractures: Dose-related edema and an increased incidence of fractures in female patients are significant safety concerns[2].
• Pancreatitis and Bladder Tumors: Acute pancreatitis and the risk of bladder cancer are potential risks associated with these medications[2][5].

Clinical Evidence and Regulatory Approvals

Clinical trials have demonstrated the efficacy of alogliptin in improving glycemic control when used as monotherapy or in combination with other antidiabetic medications like pioglitazone. Regulatory approvals, including those from the FDA, have been critical in expanding the market for these drugs. However, regulatory bodies have also highlighted the need for ongoing safety monitoring and additional clinical evidence to address long-term safety concerns[1][5].

Market Forecast and Future Outlook

The future outlook for the alogliptin benzoate and pioglitazone hydrochloride market is shaped by a complex interplay of factors, including evolving treatment paradigms, technological advancements, and changing patient demographics. As the global prevalence of type 2 diabetes continues to rise, particularly in emerging economies, the demand for effective and well-tolerated antidiabetic medications like alogliptin is expected to grow. However, this growth potential is tempered by increasing competition from newer drug classes and the entry of generic alternatives in key markets[4].

Key Takeaways

• The market for alogliptin benzoate and pioglitazone hydrochloride is driven by the increasing global prevalence of type 2 diabetes.
• The favorable safety profile and convenience of once-daily dosing enhance market adoption.
• Regulatory approvals and the growing trend towards combination therapies are key market drivers.
• Emerging economies present significant growth opportunities.
• Safety concerns, such as hepatic effects, pancreatitis, and bladder tumors, need to be carefully managed.
• The market is expected to experience significant revenue growth despite challenges from generic competition and newer drug classes.

FAQs

1. What is the primary mechanism of action of alogliptin benzoate?

Alogliptin benzoate works as a dipeptidyl peptidase-4 (DPP-4) inhibitor, enhancing the body's natural ability to lower blood glucose levels through incretin hormones[4].

2. What are the common side effects associated with alogliptin and pioglitazone hydrochloride?

Common side effects include hepatic effects, dose-related edema, fractures in female patients, and risks of pancreatitis and bladder tumors[2].

3. How does the combination of alogliptin and pioglitazone hydrochloride impact glycemic control?

The combination of alogliptin and pioglitazone hydrochloride results in improved glycemic control, as demonstrated by clinical trials showing significant reductions in HbA1c levels[1].

4. What are the key regions driving the growth of the alogliptin benzoate market?

The Asia-Pacific region, particularly Japan, China, India, and South Korea, and Latin America, especially Brazil and Mexico, are driving the growth of the alogliptin benzoate market[4].

5. What are the future trends expected to influence the market for alogliptin benzoate and pioglitazone hydrochloride?

Future trends include the increasing focus on personalized medicine, technological advancements in diabetes management, and the integration of digital health technologies[4].

Cited Sources:

1. Managed Healthcare Executive: Alogliptin: A dipeptidyl peptidase-IV inhibitor for the treatment of type 2 diabetes.
2. DailyMed: Alogliptin benzoate and pioglitazone hydrochloride tablet, film coated.
3. Market Research Intellect: Pioglitazone Hydrochloride Market Size, Scope And Forecast Report.
4. Data Horizon Research: Alogliptin Benzoate Tablet Market Size, Share, Growth, Statistics.
5. FDA: 022426Orig1s000 - accessdata.fda.gov.