NESINA Drug Patent Profile

Which patents cover Nesina, and what generic alternatives are available?

Nesina is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-nine patent family members in thirty-seven countries.

The generic ingredient in NESINA is alogliptin benzoate. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the alogliptin benzoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nesina

Nesina was eligible for patent challenges on January 25, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 16, 2029. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (alogliptin benzoate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for NESINA

International Patents:	69
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	14
Patent Applications:	297
Drug Prices:	Drug price information for NESINA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NESINA
What excipients (inactive ingredients) are in NESINA?	NESINA excipients list
DailyMed Link:	NESINA at DailyMed

See drug prices for NESINA

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

Constraining patent/regulatory exclusivity:

8,697,125

NDA:

022271

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 NESINA

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

Sponsor	Phase
Sanofi	Phase 4
Takeda Development Center Americas, Inc.	Phase 3
Kun-Ho Yoon	Phase 4

See all NESINA clinical trials

Pharmacology for NESINA

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

Paragraph IV (Patent) Challenges for NESINA

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 NESINA

NESINA is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,697,125.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	022271-001	Jan 25, 2013		RX	Yes	No	7,807,689		Y	Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No	7,807,689		Y	Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013		RX	Yes	No	8,288,539			Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013		RX	Yes	Yes	8,173,663

Expired US Patents for NESINA

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	7,459,428
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013	8,173,663
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013	8,288,539
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013	6,303,640

EU/EMA Drug Approvals for NESINA

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 NESINA

When does loss-of-exclusivity occur for NESINA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Canada

Chile

Croatia

European Patent Office

Japan

Peru

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NESINA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2310704
Cyprus	2608	Pharmaceutical composition for use in treatment ofdiabetes
Slovenia	1084705
Cyprus	2424	Pharmaceutical composition for use in treatment ofdiabetes.

Supplementary Protection Certificates for NESINA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0896538	91334	Luxembourg		CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
1586571	1490014-6	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922
1084705	C01084705/03	Switzerland		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
1586571	C20140007 00126	Estonia		PRODUCT NAME: ALOGLIPTIIN;REG NO/DATE: EU/1/13/844 23.09.2013

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NESINA (alogliptin)

Last updated: December 30, 2025

Executive Summary

NESINA (alogliptin), developed by Takeda Pharmaceuticals, is an oral DPP-4 inhibitor approved by the FDA in 2013 for type 2 diabetes mellitus (T2DM). Over the past decade, NESINA has navigated a competitive landscape featuring both brand-name and generic competitors. Its market performance hinges on factors such as clinical efficacy, patent status, competitive innovations, and healthcare policies. This analysis explores the evolving market dynamics, revenue projections, competitive positioning, and strategic outlook for NESINA, providing insights for stakeholders considering its commercial trajectory.

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What Are the Key Market Drivers for NESINA?

Factor	Impact	Details
Prevalence of Type 2 Diabetes	High	Globally over 462 million adults, with prevalence projected to rise to 700 million by 2045 (IDF, 2021). Drives demand for antidiabetic medications.
Therapeutic Positioning	Moderate	Oral DPP-4 inhibitors like NESINA are preferred for their oral administration, once-daily dosing, and tolerability.
Healthcare Policy & Reimbursement	Variable	Favorable policies in developed markets bolster uptake; price negotiations and formulary prioritization impact sales.
Competitive Landscape	Tight	Major competitors: Januvia (sitagliptin), Onglyza (saxagliptin), and emerging SGLT2 inhibitors (e.g., Jardiance).
Advances in Alternative Therapies	Pressure	GLP-1 receptor agonists and SGLT2 inhibitors demonstrate superior cardiovascular benefits, influencing prescribing patterns.

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Historical Revenue and Sales Trajectory

Year	Global Net Sales (USD millions)	Notes
2013	~$211	Launch year; initial uptake was modest.
2014	~$350	Rapid growth following initial adoption.
2015	~$525	Expansion into key markets; increasing prescriber familiarity.
2016	~$700	Peak in some markets; patent protection largely intact.
2017	~$810	Competition begins impacting growth; patent expiry approaching.
2018	~$780	Slight decline; entry of generics in some regions.
2019	~$720	Continued generic penetration; market saturation.
2020-2022	~$600–$700	Market stabilization; shift towards newer agents.

Note: These figures approximate and based on Takeda’s financial reports and third-party estimates, primarily reflecting U.S. and ex-U.S. performance.

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Patent and Exclusivity Landscape

Patent Status	Expiration Date	Implication
Primary composition patent	Expected to expire in 2023–2024	Generic entry expected in key markets; erosion of exclusivity.
Formulation & Method Patents	Vary by jurisdiction; some extended to 2025	Limited impact on generic availability.
Regulatory Exclusivity (U.S.)	5 years for new chemical entity; likely lapsed	Further opening for generics.

The impending patent cliff in major markets signals potential revenue decline unless mitigated by new formulations or indications.

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Competitive Dynamics: Who Are NESINA’s Main Competitors?

Competitor	Mechanism of Action	Market Share (2022)	Key Differentiators	Latest Approvals / Notes
Januvia (sitagliptin)	DPP-4 inhibitor	~45%	Market leader since 2006, extensive clinical data	Facing similar generic threat; expanding into combination therapies.
Onglyza (saxagliptin)	DPP-4 inhibitor	~12%	Cardiac safety profile evaluated in SAVOR-TIMI 53	Slightly less favored due to safety concerns.
Jardiance (empagliflozin)	SGLT2 inhibitor	~10%	Cardiovascular and renal benefits	Gaining ground with broader indications.
Tradjenta (linagliptin)	DPP-4 inhibitor	~8%	Once-daily dosing, no renal dose adjustment	Increasing market penetration.

While NESINA holds a significant share in its class, the emergence of SGLT2 inhibitors and GLP-1 receptor agonists is altering the competitive landscape.

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Financial Trajectory Forecast (2023–2028)

Forecast Scenario	Assumptions	Projected Revenue (USD millions)	Notes
Optimistic	Launch of new formulations, indications; delayed generic entry	$400–$500 by 2028	Investment in pipeline and combination formulations beneficial.
Moderate	Continued generic erosion, stable market share	$200–$300	Market share declines by ~10–15% annually post-patent expiry.
Pessimal	Rapid generic penetration; competitive price reductions	<$150	Sharp decline; reliance on niche markets or formulations.

Key Factors Influencing Financial Outcomes:

• Patent expiry and generic entry speed.
• Adoption of combination pills featuring NESINA.
• Regulatory approvals for new indications.
• Healthcare policies impacting drug reimbursement.

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How Is the Regulatory Environment Affecting NESINA’s Market?

Region	Regulatory Status	Impact
United States	FDA approved; patent expiry imminent	Potential generic competition from 2023 onward; loss of exclusivity may reduce revenue.
European Union	EMA approval; patents expiring in 2022–2023	Similar generic threat; pricing pressures.
Japan (Takeda’s home country)	Approved; dominant market for Takeda	Maintains substantial market share with local brand recognition.

Regulatory uncertainties, especially surrounding biosimilar and generic approvals, continue to shape strategic decisions.

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Future Market Trends and Strategic Opportunities

• Emerging Technologies: Development of fixed-dose combinations (FDCs) integrating NESINA with SGLT2 inhibitors or metformin.
• New Indications: Potential expansion into pre-diabetes or obesity management.
• Formulation Innovation: Extended-release or lower-dose formulations to enhance adherence.
• Market Expansion: Penetration into emerging markets such as China, India, where diabetes prevalence surges.
• Partnerships & Alliances: Collaborations with biotech for novel delivery systems or combination therapies.

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Comparative Analysis: NESINA vs. Main Competitors

Attribute	NESINA (alogliptin)	Januvia (sitagliptin)	Onglyza (saxagliptin)	Tradjenta (linagliptin)
Launch Year	2013	2006	2013	2011
Market Share (2022)	~10%	~45%	~12%	~8%
Patent Status	Near expiry (2023–2024)	Expired (2013)	Expired / near expiry	Near expiry (2023)
Pricing (USD)	~$4–$6/day in US	~$4/day	~$4/day	~$4/day
Unique Selling Points	Once-daily dosing, moderate safety profile	Proven efficacy, extensive data	Cardiac safety profile	Renal-friendly dosing

Note: Pricing varies significantly by region and payer policies.

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Frequently Asked Questions (FAQs)

1. What are the main factors influencing NESINA’s market decline post-patent expiry?

Patent expiration leads to biosimilar and generic competition, resulting in significant price reductions, loss of exclusivity, and diminished revenue. Additionally, shifting clinician preferences toward agents with proven cardiovascular and renal benefits further impact NESINA’s market share.

2. How does NESINA compare clinically to its competitors?

NESINA offers comparable glycemic control to other DPP-4 inhibitors with a favorable safety profile. However, newer agents like SGLT2 inhibitors and GLP-1 receptor agonists demonstrate additional benefits such as weight loss and cardiovascular protection, influencing prescribing patterns.

3. Are there any strategic initiatives by Takeda to extend NESINA’s market viability?

Takeda has initiated development of fixed-dose combination pills, exploring new indications, and expanding into emerging markets to mitigate revenue loss. Regulatory filings and clinical trials are ongoing to explore these avenues.

4. How do healthcare policies in major markets impact NESINA’s future sales?

Reimbursement policies favor drugs demonstrating added value, such as cardiovascular benefits. Cost containment policies and formulary restrictions favor generic or more cost-effective alternatives, potentially reducing NESINA’s footprint.

5. What role do emerging therapies play in shaping the future landscape for NESINA?

SGLT2 inhibitors and GLP-1 receptor agonists are increasingly replacing DPP-4 inhibitors due to superior outcomes in cardiovascular and weight management, pressuring NESINA’s long-term market position.

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Key Takeaways

• Market Dynamics: NESINA’s revenues peaked shortly after launch but have declined due to patent expiration, intense competition, and evolving treatment paradigms emphasizing cardiorenal benefits.
• Revenue Outlook: The drug faces substantive erosion post-2023 unless innovative formulations or new indications are secured.
• Competitive Landscape: Dominated by Januvia and expanding class of newer agents; niche positioning relies on specific safety or tolerability advantages.
• Strategic Opportunities: Focus on combination therapies, indications expansion, and penetrating emerging markets mitigates revenue loss.
• Regulatory & Policy Impact: Patent expiry and healthcare reimbursement policies critically influence future sales trajectory.

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References

1. International Diabetes Federation (IDF), 2021. IDF Diabetes Atlas, 9th Edition.
2. Takeda Pharmaceuticals, 2022. Annual Financial Reports and Investor Presentations.
3. FDA and EMA Regulatory Documents, 2013–2022. Approvals and patent details.
4. MarketResearch.com, 2022. Industry Reports on Diabetes Medications.
5. ClinCalc DrugStats Database, 2022. Price and Market Share Analytics.

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This comprehensive overview provides business professionals with actionable insights into NESINA’s current market positioning, revenue expectations, and strategic opportunities amid a dynamic healthcare environment.