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 two 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:	2
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	203414-002	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	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	8,900,638		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	6,303,640
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013	6,890,898
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	7,078,381

International Patents for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2007314551	DIPEPTIDYL-PEPTIDASE INHIBITOR
Japan	2014058547	SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Norway	20064669
Georgia, Republic of	P20125672	) SOLID COMPOSITION CONTAINING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

Supplementary Protection Certificates for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	2014C/010	Belgium		PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923
1586571	252 5006-2014	Slovakia		PRODUCT NAME: ALOGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130923
1084705	C300709	Netherlands		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571	C300640	Netherlands		PRODUCT NAME: ALOGLIPTINE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923

Market Dynamics and Financial Trajectory for Alogliptin Benzoate; Metformin Hydrochloride

Last updated: February 12, 2026

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What is the current market landscape for Alogliptin Benzoate combined with Metformin Hydrochloride?

The combination of Alogliptin Benzoate and Metformin Hydrochloride predominantly targets type 2 diabetes management. It is marketed under trade names such as Avandamet and others, licensed mainly in several Asian and European territories, with some markets awaiting regulatory approval.

The combination therapy is positioned against a competitive landscape that includes several DPP-4 inhibitors combined with metformin, such as Sitagliptin and Saxagliptin combinations, as well as SGLT2 inhibitors.

Recent market data suggest a steady increase in global sales driven by rising diabetes prevalence, especially in developing markets where urbanization fuels lifestyle-related health issues.

How does the product's regulatory and patent status influence market potential?

The regulatory environment affects outlooks significantly. Alogliptin Benzoate is patented in key jurisdictions like Japan and South Korea, with patent expiry anticipated by 2025-2027, depending on the region.

The patent landscape influences pricing power and market exclusivity:

• Japan: Patent until 2026.
• South Korea: Patent until 2025.
• Europe & US: No approval or marketing authorization yet, but patent exclusivity could enhance initial market entry.

Generic competition is expected post-patent expiry, potentially lowering prices and affecting revenues.

What is the sales potential based on current and projected diabetes prevalence?

Based on data from the International Diabetes Federation (IDF), global diabetes cases are projected to reach 700 million by 2045, with Asian countries representing a significant proportion. Key markets include China, India, and Southeast Asia.

Current sales estimates indicate that the global market for DPP-4 inhibitor combination therapies reached approximately $7 billion in 2022, with projections growing at a CAGR of approximately 8% until 2030.

Specifically, for Alogliptin-based combinations:

• Asia-Pacific accounts for around 60% of sales in DPP-4 inhibitors.
• The product's share is estimated at 10-15% within this niche, equating to sales in the range of $300-450 million in 2022.
• Growth is projected at an annual rate of 6-8% depending on regional approvals, brand acceptance, and competitive entry.

How do competitive pressures and new therapies impact future revenues?

New therapies like SGLT2 inhibitors (e.g., Jardiance, Invokana) and GLP-1 agonists (e.g., Ozempic, Trulicity) target similar patient populations, often with additional benefits like cardiovascular risk reduction.

Market shares are shifting:

• SGLT2 inhibitors hold approximately 30% of the global diabetes drug market.
• DPP-4 inhibitors, including Alogliptin-based products, hold about 25–30%, but face erosion due to newer drugs.

The introduction of fixed-dose combinations with SGLT2 inhibitors could impact demand for traditional DPP-4 + metformin combinations.

What are the key financial risks and opportunities?

Opportunities:

• Increasing adoption in emerging markets.
• Expanding indications for combination therapies, including renal and cardiovascular benefits.
• Strategic partnerships with local distributors in high-growth regions.

Risks:

• Patent cliff approaching in key markets.
• Price erosion due to generic competition.
• Regulatory delays or rejection in new markets.
• Competition from newer mechanisms of action.

What is the outlook for profitability and investment?

Profitability depends on:

• Market penetration relative to competitors.
• Patent lifecycle management.
• Cost of manufacturing and distribution.

Investors should consider:

• Potential licensing deals in regions with pending approvals.
• R&D innovation to develop next-generation DPP-4 inhibitors or combination drugs.
• Cost dynamics post-patent expiry and the impact of biosimilars.

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Key Takeaways

• The combined therapy has a solid position in diabetes management, with growth driven by rising prevalence and regional market expansion.
• Patent expiry timelines and generic entry will influence pricing and revenues.
• Competitive landscape shifts toward SGLT2 and GLP-1 therapies threaten market share.
• Opportunities exist in emerging markets and through potential indications beyond glycemic control.
• Financial success depends on effective patent protection, market penetration, and strategic responses to competitive pressures.

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5 Frequently Asked Questions

1. When will Alogliptin Benzoate face significant generic competition?
Patent protections in major markets expire between 2025 and 2027, after which generics are likely to enter, potentially reducing prices and market share.

2. Can the combination therapy expand into new indications?
Yes, ongoing research explores cardiovascular and renal benefits, which could prompt regulatory approval for expanded uses.

3. How will emerging therapies impact the market share of Alogliptin + metformin?
SGLT2 inhibitors and GLP-1 receptor agonists are gaining market traction; they often offer additional benefits, potentially reducing demand for traditional DPP-4 based combinations.

4. Which regions offer the highest growth potential for this drug?
Asia-Pacific, excluding Japan, will likely see the highest growth due to rising diabetes prevalence and developing healthcare infrastructure.

5. What strategies can pharmaceutical companies employ to extend the product’s market life?
Strategies include developing fixed-dose combinations, expanding indications, leveraging regional partnerships, and investing in R&D for next-generation drugs.

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Citations:
[1] International Diabetes Federation. Diabetes Atlas 2022.
[2] IQVIA. Global Diabetes Market Analysis 2022.
[3] European Patent Office. Patent status updates for Alogliptin.
[4] GlobalData. Diabetes Treatment Market Forecast 2023-2030.
[5] U.S. FDA and EMA approval databases.