ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - Generic Drug Details

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

Alogliptin benzoate; metformin 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 and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate; metformin hydrochloride has ninety patent family members in forty-one countries.

Three suppliers are listed for this compound.

Summary for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

International Patents:	90
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
DailyMed Link:	ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

8,900,638

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; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
Takeda	Phase 4
Celltrion Pharm, Inc.	Phase 4
Seoul National University Hospital	Phase 4

See all ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

A10BA	Biguanides
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

Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KAZANO	Tablets	alogliptin benzoate; metformin hydrochloride	12.5 mg/500 mg and 12.5 mg/1000 mg	203414	3	2017-01-25

US Patents and Regulatory Information for ALOGLIPTIN BENZOATE; METFORMIN 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	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No	7,807,689		Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes	8,173,663
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No	8,900,638		Y

Expired US Patents for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013	5,965,584
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013	6,211,205
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013	5,965,584

International Patents for ALOGLIPTIN BENZOATE; METFORMIN 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; METFORMIN 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; METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alogliptin Benzoate and Metformin Hydrochloride

Introduction to Alogliptin Benzoate and Metformin Hydrochloride

Alogliptin benzoate and metformin hydrochloride are two crucial medications in the management of type 2 diabetes mellitus. Alogliptin benzoate is a DPP-4 inhibitor, while metformin hydrochloride is a biguanide. When used together, they form a potent combination for controlling blood glucose levels.

Market Drivers

Increasing Prevalence of Type 2 Diabetes

The global prevalence of type 2 diabetes is a significant driver for the market growth of alogliptin benzoate and metformin 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 escalating demand for antidiabetic medications creates a substantial market opportunity[4].

Favorable Efficacy and Safety Profile

Alogliptin benzoate's mechanism of action as a DPP-4 inhibitor, enhancing the body's natural ability to lower blood glucose levels through incretin hormones, is highly effective and associated with a lower risk of hypoglycemia compared to other antidiabetic medications. This favorable efficacy and safety profile has led to increased adoption by healthcare providers and patients, driving market growth[4].

Regulatory Approvals and Market Penetration

Regulatory approvals in major markets have significantly boosted the market penetration of alogliptin benzoate tablets. This includes approvals in countries like Japan, where alogliptin was first developed and approved, and other key markets in the Asia-Pacific region[4].

Combination Therapies

The growing trend towards combination therapies involving alogliptin and metformin hydrochloride is another market driver. The fixed-dose combination of alogliptin benzoate and metformin hydrochloride has shown significant reductions in HbA1c levels, supporting its rationale and acceptance in clinical practice[5].

Market Segments and Applications

By Type

• Alogliptin Benzoate Tablets: Available in various strengths such as 6.25mg and 12.5mg, these tablets are used as monotherapy or in combination with other antidiabetic medications[1][4].
• Metformin Hydrochloride: Available in forms such as Metformin HCL and Metformin DC, with applications including tablets and extended-release tablets[3].

By Application

• Hospital, Clinic, and Pharmacy: These are the primary end-use sectors driving the demand for alogliptin benzoate and metformin hydrochloride. The expanding demands from these sectors are propelling the market forward[1].
• Combination Therapies: The use of alogliptin benzoate and metformin hydrochloride in combination therapies is a significant application, enhancing their market presence[5].

Regional Outlook

Asia-Pacific

The Asia-Pacific region, particularly countries like China, India, Japan, and South Korea, shows high growth potential for alogliptin benzoate tablets. This is driven by the rising prevalence of diabetes, improving healthcare access, and increasing awareness of modern diabetes treatments[1][4].

Latin America

Latin America, with countries like Brazil and Mexico, offers considerable growth potential. The region is characterized by a growing middle class with increasing access to advanced healthcare treatments, although market penetration varies significantly across different countries[4].

United States

The U.S. market for alogliptin benzoate tablets is expected to grow at a significant CAGR over the forecast period, driven by the increasing prevalence of type 2 diabetes and the favorable safety profile of the medication[1].

Financial Trajectory

Market Size and Forecast

The global market for alogliptin benzoate tablets is expected to witness exponential growth at a significant CAGR during the forecast period. By 2029, the market is projected to reach substantial revenue, driven by the increasing demand from various end-use industries such as hospitals, clinics, and pharmacies[1][4].

Revenue Growth Rate

The revenue growth rate for the alogliptin benzoate tablet market is anticipated to be robust, driven by the escalating global prevalence of type 2 diabetes and the favorable safety and efficacy profile of the medication. The market in China, for example, is forecast to reach significant revenue by 2029, trailing a CAGR over the 2023-2029 period[1].

Challenges and Opportunities

Generic Competition

Generic competition is a significant challenge in some markets, leading to price pressures. However, this can also create opportunities for branded manufacturers to differentiate their products through innovative formulations and digital health solutions[4].

Integration of Digital Health Technologies

The integration of digital health technologies with alogliptin treatment regimens represents a promising opportunity. Developing companion apps for medication adherence, glucose monitoring, and lifestyle management could enhance treatment outcomes and patient engagement, providing valuable real-world data on the medication's effectiveness and safety[4].

Personalized Medicine

The increasing focus on personalized medicine in diabetes care is likely to influence the future of the alogliptin market. As our understanding of genetic and metabolic factors improves, there is potential for more targeted use of alogliptin in specific patient subgroups, potentially strengthening its position in the market[4].

Regulatory and Clinical Aspects

Clinical Studies and Approvals

Clinical studies, such as the phase 3 study MET-302, have demonstrated the efficacy of alogliptin benzoate and metformin hydrochloride in reducing HbA1c levels. These studies have supported the regulatory approvals and acceptance of these medications in clinical practice[5].

Analytical Methods

The development and validation of analytical methods, such as UV spectrophotometric methods, have ensured the accurate and precise estimation of alogliptin benzoate and metformin hydrochloride in bulk and pharmaceutical dosage forms. These methods are crucial for routine quality control and have been validated according to ICH guidelines[2].

Key Takeaways

• The global market for alogliptin benzoate tablets is driven by the increasing prevalence of type 2 diabetes and the favorable safety and efficacy profile of the medication.
• The Asia-Pacific region, particularly China, Japan, India, and South Korea, shows high growth potential.
• Combination therapies involving alogliptin benzoate and metformin hydrochloride are a significant market driver.
• Integration of digital health technologies and personalized medicine approaches are expected to shape the future market dynamics.
• Generic competition and varying regulatory requirements are key challenges that need to be addressed.

FAQs

What is the primary driver of the alogliptin benzoate tablet market?

The primary driver is the escalating global prevalence of type 2 diabetes mellitus, creating a substantial and growing patient pool for antidiabetic medications[4].

How does the combination of alogliptin benzoate and metformin hydrochloride benefit patients?

The combination has shown significant reductions in HbA1c levels and is associated with a lower risk of hypoglycemia, making it a favorable treatment option for patients with type 2 diabetes[5].

What regions offer the most growth potential for alogliptin benzoate tablets?

The Asia-Pacific region, particularly countries like China, Japan, India, and South Korea, and Latin America, especially Brazil and Mexico, offer considerable growth potential[1][4].

How does generic competition impact the market for alogliptin benzoate tablets?

Generic competition leads to price pressures in some markets but also creates opportunities for branded manufacturers to differentiate their products through innovative formulations and digital health solutions[4].

What role does digital health technology play in the market for alogliptin benzoate tablets?

Digital health technologies, such as companion apps for medication adherence and glucose monitoring, enhance treatment outcomes and patient engagement, providing valuable real-world data on the medication's effectiveness and safety[4].

Sources

1. QYResearch: Alogliptin Benzoate Tablet - Global Market Insights and Sales.
2. Der Pharma Chemica: Development and validation of UV spectrophotometric method for simultaneous estimation of metformin hydrochloride and alogliptin benzoate.
3. Biospace: Metformin Hydrochloride Market Analysis, Industry Size, Share.
4. DataHorizonResearch: Alogliptin Benzoate Tablet Market Size, Share, Growth, Statistics.
5. FDA: 203414Orig1s000 - Alogliptin benzoate and metformin hydrochloride fixed dose combination.