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 four 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:	4
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

Constraining patent/regulatory exclusivity:

8,697,125

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
Takeda	Phase 4
Celltrion Pharm, Inc.	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	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013		DISCN	Yes	No	8,637,079		Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No	8,637,079		Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013		RX	Yes	Yes	8,697,125		Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013		RX	Yes	No	7,807,689		Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes	8,637,079		Y

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	022271-003	Jan 25, 2013	6,150,383
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013	6,303,640
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013	6,303,661
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013	6,150,383
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013	8,288,539

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
Japan	2007314551	DIPEPTIDYL-PEPTIDASE INHIBITOR
Norway	20064669
Japan	4948298
Hungary	S1400007
Slovenia	1586571

Supplementary Protection Certificates for alogliptin benzoate

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
1586571	C01586571/01	Switzerland		PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 62955 22.11.2013

Market Dynamics and Financial Trajectory for ALOGLIPTIN BENZOATE

Last updated: February 12, 2026

Overview

Alogliptin benzoate is a dipeptidyl peptidase-4 (DPP-4) inhibitor used mainly for type 2 diabetes management. Approved by the FDA in 2013 as Nesina, it targets glycemic control. The drug faces competitive pressures from other DPP-4 inhibitors, notably sitagliptin and linagliptin. Its market dynamics depend on regulatory status, patent lifecycle, clinical positioning, and pricing strategies.

Regulatory and Patent Landscape

• FDA Approval: December 2013 for type 2 diabetes.
• Patents: Original patents expired in 2020 in the U.S., opening generic opportunities. Patent disputes or extensions could modify exclusivity periods.
• Global approvals: Approved in Japan, the European Union, and other markets, with some regional variations in indications.

Market Size and Growth Drivers

• Global Type 2 Diabetes Market: Estimated at $94.7 billion in 2022, with a compound annual growth rate (CAGR) of approximately 7% through 2030.[1]

• DPP-4 inhibitors segment: Accounts for roughly 25% of the oral antidiabetic medication market. The segment was valued at approximately $23.7 billion in 2022, growing with a CAGR of 8%.[1]

• Alogliptin’s Market Share: Estimated at 4-6% of the DPP-4 inhibitor segment pre-generic entry, with potential for expansion if it gains positioning in combination therapies.

Pricing and Revenue Expectations

• Pricing: Branded alogliptin tablets priced at approximately $300 for a 30-day supply in the U.S. pre-generic. Generics could reduce prices by 70-80%, potentially lowering annual revenue to below $50 million depending on market adoption.
• Revenue Projections: Prior to patent expiration, peak sales projected at $600-$800 million annually in existing markets.[2] Post-patent, revenue could decline sharply unless differentiated through formulations or combinations.

Competitive Positioning

• Main Competitors: Sitagliptin (Januvia, Merck), linagliptin (Trajenta, Boehringer Ingelheim/BMS), saxagliptin (Onglyza, AstraZeneca).
• Differentiation: Limited clinical differentiation among DPP-4 inhibitors; market success depends on pricing, patent strategy, and combination therapies.

Regulatory and Clinical Development Trends

• Additional Indications: Clinical trials for cardiometabolic benefits, potential combination with SGLT2 inhibitors.
• Registrations: Some regions seek re-approval or new formulations, influencing future revenue streams.

Market Challenges and Opportunities

• Challenges: Patent expiry, aggressive pricing of generics, competition from SGLT2 and GLP-1 receptor agonists offering superior cardiovascular and weight-loss benefits.
• Opportunities: Development of fixed-dose combinations, exploring novel indications, expanding into emerging markets with larger patient populations.

Financial Outlook Summary

Factor	Status	Impact on Revenue
Patent Expiry	2020 in the U.S.	Revenue decline anticipated
Market Penetration	Moderate pre-generic	Limited growth post-generic entry
Competitive Intensity	High	Pressure on pricing and market share
Clinical Pipeline	Ongoing trials	Possible future indications or formulations

Conclusion

Alogliptin benzoate's market trajectory is characterized by high competition, patent expiration, and rapid price erosion. Its future revenue depends on strategies to differentiate, capture niche markets, and expand into combination therapies. The next 3-5 years will be critical in establishing its post-patent market share and diversification pathways.

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Key Takeaways

• The global diabetes market is expanding, driving demand for DPP-4 inhibitors, including alogliptin.
• Patent expiration in the U.S. in 2020 has opened the market to generics, likely reducing revenues substantially unless mitigated by new formulations or indications.
• Competition from other DPP-4 inhibitors and emerging drug classes presents pricing and market share challenges.
• Opportunities exist in developing combination therapies and exploring new indications, especially in emerging markets.
• Revenue projections post-2020 suggest significant decline unless strategic repositioning occurs.

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FAQs

1. What factors most influence alogliptin’s market share after patent expiration?

   • Patent expiry, pricing strategies, clinician preferences, and development of combination therapies.

2. How does alogliptin compare with other DPP-4 inhibitors in clinical efficacy?

   • Clinical efficacy is generally comparable among DPP-4 inhibitors; differences are often marginal and depend on patient subsets.

3. What is the potential for alogliptin in emerging markets?

   • High, due to larger diabetes populations and price sensitivities, especially if low-cost generics are available.

4. Are there ongoing clinical trials for new indications of alogliptin?

   • Yes, including cardiovascular outcomes and combination therapies with SGLT2 inhibitors.

5. How do regulatory policies impact alogliptin’s future?

   • Regulatory decisions on patents, approvals for new formulations, and health policy coverage critically influence profitability.

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Citations

[1] Grand View Research, "Type 2 Diabetes Market Size & Share Analysis," 2022.
[2] MarketWatch, "DPP-4 Inhibitors Market Forecast," 2023.