ALOGLIPTIN BENZOATE - Generic Drug Details

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

Alogliptin benzoate is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate has sixty-nine patent family members in thirty-seven countries.

There are ten drug master file entries for alogliptin benzoate. Five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ALOGLIPTIN BENZOATE

International Patents:	69
US Patents:	6
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALOGLIPTIN BENZOATE
DailyMed Link:	ALOGLIPTIN BENZOATE at DailyMed

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

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

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 clinical trials

Generic filers with tentative approvals for ALOGLIPTIN BENZOATE

Applicant	Application No.	Strength	Dosage Form
		6.25MG	TABLET;ORAL
		EQ 25MG BASE	TABLET;ORAL
		EQ 12.5MG BASE	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 ALOGLIPTIN BENZOATE

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

Anatomical Therapeutic Chemical (ATC) Classes for ALOGLIPTIN BENZOATE

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NESINA	Tablets	alogliptin benzoate	6.25 mg, 12.5 mg and 25 mg	022271	5	2017-01-25

US Patents and Regulatory Information for ALOGLIPTIN BENZOATE

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	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No				Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No			Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No			Y	Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No

Expired US Patents for ALOGLIPTIN BENZOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013

EU/EMA Drug Approvals for ALOGLIPTIN BENZOATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharma A/S	Vipidia	alogliptin benzoate	EMEA/H/C/002182Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).	Authorised	no	no	no	2013-09-18

International Patents for ALOGLIPTIN BENZOATE

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0418639	inibidores de dipeptidil peptidase
Luxembourg	92374
Croatia	P20080509
Canada	2559302	INHIBITEURS DE LA DIPEPTIDYLE PEPTIDASE (DIPEPTIDYL PEPTIDASE INHIBITORS)
Denmark	1586571
Norway	20064669

Supplementary Protection Certificates for ALOGLIPTIN BENZOATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	C300709	Netherlands		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705	CA 2014 00066	Denmark		PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
1586571	1490014-6	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922
1586571	C20140007 00126	Estonia		PRODUCT NAME: ALOGLIPTIIN;REG NO/DATE: EU/1/13/844 23.09.2013
1084705	PA2014045	Lithuania		PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1586571	172 5006-2014	Slovakia		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: Alogliptin Benzoate

Introduction
Alogliptin benzoate is an oral antihyperglycemic agent primarily used in managing type 2 diabetes mellitus (T2DM). As a selective dipeptidyl peptidase-4 (DPP-4) inhibitor, alogliptin enhances the body's incretin system, promoting insulin secretion and reducing glucagon levels. The compound’s clinical profile, regulatory landscape, and evolving market trends profoundly impact its commercial potential and financial trajectory. This analysis explores the factors shaping alogliptin benzoate’s market dynamics, competitive landscape, and projected financial outcomes.

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Market Overview and Demand Drivers

The global T2DM epidemic fuels demand for novel, efficacious, and safe antihyperglycemic medications. The prevalence of diabetes reached approximately 537 million adults globally in 2021, with projections estimating this figure will surpass 700 million by 2045, according to the International Diabetes Federation.[1] This rising burden underscores significant opportunities for DPP-4 inhibitors like alogliptin.

The improved safety profiles of DPP-4 inhibitors—particularly relative to sulfonylureas and insulin—have led to widespread adoption. Alogliptin specifically benefits from once-daily dosing, glycemic efficacy, and a favorable tolerance profile, further bolstering its market appeal. Increasing awareness among healthcare providers about oral options for managing T2DM also supports sustained demand growth.

Regulatory and Patent Landscape

Initially approved by the U.S. Food and Drug Administration (FDA) in 2013 under the brand name Nesina, alogliptin faced patent protections that delayed generic competition. Its exclusivity period, combined with the high cost of branded medications, amplified profitability during the early years.[2]

However, patent cliffs threaten future revenues, particularly as generic versions gain approval in global markets. For example, Japan's approval of generic alogliptin has already affected pricing and sales volumes.[3] Continuous patent litigation and evergreening strategies remain critical for innovator companies to prolong exclusivity. Regulatory approval processes in emerging markets also impact the globalization timeline of alogliptin’s commercial reach.

Competitive Landscape

Alogliptin competes with other DPP-4 inhibitors such as sitagliptin, saxagliptin, linagliptin, and vildagliptin. Market leaders like Merck’s Januvia (sitagliptin) dominate due to early market entry and extensive clinical data. However, alogliptin’s niche positioning, especially in Asia-Pacific, enables regional growth.

Emerging combination therapies, such as fixed-dose combinations with metformin or SGLT2 inhibitors, pose both opportunities and challenges. These combinations simplify regimens, potentially improving adherence, but also intensify competition among formulary options.

Pricing and Reimbursement Factors

Pricing dynamics are crucial for alogliptin’s financial trajectory. Branded molecules typically command premium pricing in developed markets, but increasing generic entries pressure prices downward post-expiration of exclusivity. Reimbursement policies in major markets like the U.S., Europe, and Japan influence sales volume and revenue streams. Countries with robust healthcare coverage tend to favor sustained adoption of innovative therapies, benefiting alogliptin's market access prospects. Conversely, cost-containment measures threaten profit margins in commoditized segments.[4]

Market Penetration Strategies

Pharmaceutical companies leverage multiple channels to bolster alogliptin's market share:

• Aggressive marketing: Education campaigns targeting physicians about efficacy and safety.
• Strategic partnerships: Collaborations with healthcare systems and payers to facilitate formulary inclusion.
• Market expansion: Focused penetration in high-growth regions—particularly China, India, and Southeast Asia—where T2DM prevalence is surging.

Financial Trajectory and Revenue Forecasts

Considering the current market valuation, patent expirations, and competitive pressures, the financial trajectory for alogliptin reflects a typical lifecycle pattern of innovative drugs.

• Initial Revenue Phase (2013–2020): Rapid growth driven by patent exclusivity and high-priced branded formulations. Peak revenues observed during these years, with global sales surpassing $1 billion annually.[5]

• Post-Patent Decline (2021–2025): Introduction of generics in key markets diminishes revenues. Price erosion and volume decline lead to a tapering of income streams. Companies often offset this by expanding into emerging markets and developing combination therapies.

• Long-term Outlook (2026 onward): Revenue stabilizes at a lower level, sustained by markets with delayed generic entry and regional growth initiatives. Anticipated annual revenues may settle in the several hundred million-dollar range, contingent on market penetration and pricing strategies.

Emerging Trends and Opportunities

The future financial landscape for alogliptin hinges on several factors:

• Biosimilar and generic competition: Accelerated approvals in multiple markets threaten current revenue streams. Strategic patent litigations and licensing agreements could delay market entry.

• Combination drug markets: Developing fixed-dose combinations with metformin or SGLT2 inhibitors could preserve profitability and market share. Such innovations often command premium prices and extend product lifecycle.[6]

• Personalized medicine and digital health integration: Tailoring therapy based on patient genetics and leveraging digital adherence tools may improve treatment outcomes, indirectly supporting alogliptin’s market presence.

• Regulatory shifts: Evolving policies promoting biosimilars and price controls can significantly impact profit margins. Navigating this landscape requires proactive regulatory strategies.

Market Risks and Challenges

Factors potentially impeding alogliptin’s financial success include:

• Generic entry and pricing pressure: Accelerating patent expiration reduces margins.

• Market saturation and competition: Diversified treatment options and new classes, such as GLP-1 receptor agonists, offer competing mechanisms.

• Regulatory hurdles in emerging markets: Variability in approval timelines and reimbursement policies can impede global expansion.

• Physician and patient preferences: Preference for newer agents with proven cardiovascular benefits may limit usage of DPP-4 inhibitors like alogliptin.

Conclusion

Alogliptin benzoate’s market dynamics reflect a typical lifecycle dictated by patent protections, competitive forces, and regional growth opportunities. Its initial strong financial trajectory is now gradually waning in mature markets due to generic competition. Strategic expansion into emerging markets, development of fixed-dose combinations, and adaptation to regulatory landscapes are essential to sustain revenue streams. Ongoing innovation and efficient lifecycle management will determine the drug’s long-term profitability.

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Key Takeaways

• The global increase in T2DM prevalence sustains demand for alogliptin, but patent expirations and competition constrain future revenues.
• Regional market expansion, especially in Asia, offers growth opportunities amidst generic-driven price declines in mature markets.
• Developing combination therapies can extend product life and preserve margins but require significant R&D investment.
• Navigating regulatory environments and patent landscapes remains critical for prolonging exclusivity and market share.
• The financial outlook indicates a decline in peak revenues, emphasizing the importance of diversification and innovation to maintain profitability.

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FAQs

1. When did alogliptin benzoate receive FDA approval, and what was its initial market impact?
Alogliptin was approved by the FDA in 2013 under the brand Nesina, leading to rapid adoption in the U.S. with revenues exceeding $1 billion in peak years due to patent exclusivity and clinical demand.[2]

2. How does patent expiration influence alogliptin’s market potential?
Patent expiration exposes alogliptin to generic competition, significantly reducing prices and revenue streams, which necessitates strategic measures like patent litigations, licensing, or product diversification to sustain profitability.

3. What regional factors affect the global market for alogliptin?
Regulatory approval timelines, reimbursement policies, and market price sensitivities vary, with Asian markets offering significant growth potential due to rising diabetes prevalence, despite potential delays in approvals and market access challenges.

4. Can alogliptin be combined with other drugs to improve its market sustainability?
Yes, fixed-dose combinations with metformin or SGLT2 inhibitors can enhance adherence, extend lifecycle, and justify premium pricing, making this a strategic focus for companies to maintain competitiveness.

5. What are the primary risks facing alogliptin’s long-term financial outlook?
Key risks include rapid generic entry, competitive alternatives such as GLP-1 receptor agonists, regulatory hurdles in emerging markets, and shifting clinician and patient preferences toward newer therapies.

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References
[1] International Diabetes Federation. "IDF Diabetes Atlas," 2021.
[2] U.S. Food and Drug Administration. "Nesina (Alogliptin) prescribing information," 2013.
[3] Japan Pharmaceuticals and Medical Devices Agency. "Generic drug approvals," 2022.
[4] IQVIA Institute. "The Global Use of Medicine in 2021," 2021.
[5] EvaluatePharma. "2019 Global Top 100 Pharma Reports."
[6] SteadyMed Therapeutics. "Fixed-dose combinations in diabetes treatment," 2020.