Alogliptin benzoate; metformin hydrochloride - Generic Drug Details

What are the generic drug sources for alogliptin benzoate; metformin hydrochloride and what is the scope of patent protection?

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
Celltrion Pharm, Inc.	Phase 4
Takeda	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	8,900,638		Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes	7,807,689		Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No	8,173,663

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	6,150,384
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013	6,329,404
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013	6,211,205
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013	8,173,663

International Patents for alogliptin benzoate; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
New Zealand	549716	Pyrimidin-dione derivatives as dipeptidyl peptidase inhibitors
Norway	2014004
Peru	20140923	PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA
Dominican Republic	P2010000028

Supplementary Protection Certificates for alogliptin benzoate; metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	2014/012	Ireland		PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705	CR 2014 00066	Denmark		PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
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	C01084705/05	Switzerland		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013

Market Dynamics and Financial Trajectory for Alogliptin Benzoate and Metformin Hydrochloride

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape surrounding antidiabetic agents has observed significant shifts over recent years, driven by rising global diabetes prevalence, innovative drug development, and evolving regulatory frameworks. Among the prominent medications targeted at managing Type 2 Diabetes Mellitus (T2DM), alogliptin benzoate and metformin hydrochloride stand out due to their widespread use, unique mechanisms, and market influence. This analysis explores the current market dynamics and financial trajectories of these drugs, offering insights for stakeholders across industries including pharmaceutical manufacturing, investment, and healthcare policy.

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Market Overview

Alogliptin Benzoate: A DPP-4 Inhibitor

Alogliptin benzoate, marketed under brands such as Nesina, belongs to the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Approved by the US Food and Drug Administration (FDA) in 2013, alogliptin is primarily prescribed as an adjunct to diet and exercise to improve glycemic control in T2DM patients. Its mechanism involves prolonging incretin hormone activity, thereby stimulating insulin release and decreasing glucagon secretion.

Despite being a relatively newer entry in the antidiabetic segment, alogliptin has gained market traction owing to its favorable safety profile and once-daily dosing regimen. However, its market share competes with established DPP-4 inhibitors like sitagliptin, saxagliptin, and linagliptin, which have broader brand recognition and more extensive clinical data.

Metformin Hydrochloride: The Conventional Cornerstone

Metformin hydrochloride is the de facto first-line therapy for T2DM globally, recognized for its efficacy in reducing hepatic glucose production, favorable safety profile, and cost-effectiveness. Since its discovery in the 1950s and subsequent market approval, metformin has maintained dominant market presence, often as monotherapy or part of combination therapies.

Despite newer agents emerging, metformin continues to occupy a pivotal role in diabetes management, with a consistently growing global consumption volume driven by the rising burden of T2DM.

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Market Dynamics

Global Incidence of Diabetes and Its Impact

The escalating prevalence of T2DM significantly influences demand for both alogliptin benzoate and metformin. According to the International Diabetes Federation (IDF), approximately 537 million adults worldwide had diabetes in 2021, projected to reach 643 million by 2030 [1]. The growth is most pronounced in low- and middle-income countries, prompting an urgent need for accessible, affordable therapies like metformin.

This increasing prevalence accelerates market growth for established drugs (metformin) and fosters interest in newer agents (alogliptin) as patients seek tailored, effective treatments with manageable side effects.

Regulatory and Patent Landscapes

The patent expiry of metformin in several jurisdictions has facilitated an influx of generic formulations, underpinning its affordability and widespread use. Conversely, alogliptin remains under patent protection, providing exclusivity that sustains higher pricing and profitability for innovator firms like Takeda.

Regulatory approvals for alogliptin have expanded in various regions, including Japan, the US, and Europe, supplemented by favorable safety profiles. Nonetheless, regulatory scrutiny for DPP-4 inhibitors concerning long-term cardiovascular outcomes has tempered some market enthusiasm.

Competitive Landscape

The market for T2DM drugs is highly competitive. Metformin's dominance is challenged only by newer oral agents such as SGLT2 inhibitors and GLP-1 receptor agonists, which demonstrate additional cardiovascular benefits.

Alogliptin faces stiff competition; sitagliptin (Merck) holds a substantial market share globally, with other DPP-4 inhibitors vying for position. The incremental clinical benefits over older agents, complex pricing strategies, and formulary restrictions influence market shares.

Pricing and Reimbursement

Cost remains a pivotal factor, especially in emerging markets. The availability of generic metformin reduces patient costs and influences prescribing behaviors. In contrast, alogliptin's branded status results in higher prices, which may limit access in resource-constrained settings.

Reimbursement policies in different countries significantly impact sales volumes. Countries with comprehensive insurance schemes tend to favor newer, branded therapies like alogliptin, whereas cost-sensitive markets gravitate toward generics.

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Financial Trajectory and Market Forecast

Revenue Trends

• Metformin Hydrochloride: The global market for metformin is valued at approximately USD 600-700 million, with a compound annual growth rate (CAGR) of around 5% projected between 2022 and 2027 [2]. The growth is driven by increasing T2DM prevalence, patent expirations facilitating generics, and its cornerstone status in therapy algorithms.

• Alogliptin Benzoate: As a relatively newer agent, alogliptin's global sales are smaller, estimated at USD 200-300 million, with a projected CAGR of 8-10% over the next five years [3]. The growth trajectory hinges on expanding approvals, physician acceptance, and positioning within treatment guidelines.

Market Penetration and Expansion

The expansion of alogliptin is expected in Japan, the US, and select European markets. Strategic collaborations and ongoing clinical trials exploring cardiovascular and renal outcomes bolster its adoption.

Metformin's trajectory peaks in generic markets but faces saturation in high-income regions. Nevertheless, emerging economies present substantial growth opportunities, with increasing access and healthcare infrastructure improvements.

Emerging Trends

• Combination Therapies: Both alogliptin and metformin are increasingly included in fixed-dose combinations (FDCs), enhancing adherence and simplifying regimens. The FDC market for antidiabetics is projected to grow at an estimated CAGR of 7% through 2027.

• Novel Delivery Systems: Extended-release formulations of metformin improve gastrointestinal tolerability, fostering market expansion.

• Regulatory Developments: Recent FDA guidelines emphasizing cardiovascular safety have led to post-marketing studies, influencing labeling and market perception.

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Challenges Impacting Financial Trajectory

• Intense Pricing Pressure: Shift towards generics for metformin constrains profit margins for branded formulations.

• Clinical Efficacy and Safety Perceptions: Ongoing debates surrounding DPP-4 inhibitors' cardiovascular safety influence prescribing patterns, impacting future sales.

• Regulatory Hurdles: Variances in approval processes may constrain alogliptin's international expansion.

• Market Saturation: The mature status of the metformin market limits incremental revenue opportunities, with growth driven mainly by volume.

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Opportunities for Growth

• Personalized Medicine: Stratified therapies targeting specific patient subgroups may open new markets.

• Global Access Initiatives: Strategies focusing on affordability and distribution channels in developing nations can amplify sales of generic metformin.

• Research Expansion: Evidence from ongoing trials on alogliptin's cardiovascular and renal benefits may enhance its positioning and market acceptance.

• Combination Products: Developing FDCs with other antidiabetic agents or cardiovascular drugs can increase market share.

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Key Takeaways

• The global diabetes epidemic sustains robust demand for both metformin and alogliptin, with the former maintaining dominance due to its affordability and longstanding clinical utility.

• Patent protections for alogliptin afford exclusivity, fostering growth in emerging markets, but face competitive pressures from established agents and second-generation therapies.

• The metformin market benefits from widespread acceptance and generics, yet growth potential is moderated by market saturation and price competition.

• Strategic focus on combination therapies, new formulations, and expanding into underserved markets will define the financial trajectories.

• Regulatory developments, clinical safety data, and healthcare policies significantly influence market dynamics, requiring continuous monitoring.

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FAQs

1. How does the patent status of alogliptin benzoate influence its market potential?
Patent protection grants exclusive rights, allowing for premium pricing and market control, which boosts revenue streams and investment in marketing. Once patents expire, generic competitors enter, significantly reducing prices and shrinking profit margins, unless differentiated by clinical advantages or formulation innovations.

2. What factors contribute to the continued dominance of metformin in T2DM management despite newer drugs?
Metformin's proven efficacy, safety profile, low cost, and extensive clinical evidence underpin its continued dominance. Additionally, its inclusion in treatment guidelines universally recommends it as first-line therapy, reinforcing its market position.

3. Are there regional variations in the market for these drugs?
Yes. Developed markets favor branded alogliptin due to regulatory and reimbursement landscapes, while emerging economies largely rely on affordable generics of metformin. Regulatory approvals, healthcare infrastructure, and economic factors drive regional differences.

4. How do combination therapies impact the financial outlook of these drugs?
Fixed-dose combinations enhance adherence, potentially improve clinical outcomes, and expand market presence, leading to increased revenues. Both drugs are being incorporated into FDCs, which are projected to grow at a rate exceeding the individual components.

5. What is the outlook for upcoming clinical trials involving alogliptin?
Promising results from trials assessing cardiovascular and renal benefits could bolster alogliptin’s market appeal, influence label extensions, and provide a competitive edge. Positive outcomes may lead to increased prescribing and new regulatory approvals.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 2021.
2. MarketsandMarkets. Antidiabetic Drugs Market — Global Forecast to 2027.
3. EvaluatePharma. Pharmaceutical Market Intelligence Reports.