NESINA Drug Patent Profile

When do Nesina patents expire, and when can generic versions of Nesina launch?

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

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
Takeda	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.

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			Y	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	022271-001	Jan 25, 2013		RX	Yes	No				Y
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013		RX	Yes	Yes
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No				Y

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
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

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
Japan	3973280
Luxembourg	92611
Russian Federation	2323004	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (PHARMACEUTICAL COMPOSITION)
Hong Kong	1010484
Slovakia	287287

Supplementary Protection Certificates for NESINA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1174135	437	Finland
1084705	SPC/GB14/084	United Kingdom		PRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
1084705	C01084705/05	Switzerland		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
1084705	PA2014042	Lithuania		PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
1084705	C300708	Netherlands		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224

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

Last updated: July 27, 2025

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Introduction

NESINA (alogliptin) is an oral antidiabetic medication developed by Takeda Pharmaceutical Company. Approved by the U.S. Food and Drug Administration (FDA) in 2013, it functions as a selective dipeptidyl peptidase-4 (DPP-4) inhibitor used primarily to manage type 2 diabetes mellitus (T2DM). As the global prevalence of T2DM surges, understanding NESINA's market dynamics and its financial trajectory provides insights into its commercial performance, competitive positioning, and future prospects.

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Market Landscape for DPP-4 Inhibitors

The pharmaceutical landscape for anti-diabetic agents has transformed considerably over the past decade. DPP-4 inhibitors like NESINA entered the market amid rising demand for oral, well-tolerated T2DM therapies. Major competitors include merck's JANUVIA (sitagliptin), Pfizer's ZETIA (vildagliptin—approved in some markets), and Novartis's Onglyza (saxagliptin).

The global T2DM treatment market is projected to reach USD 127 billion by 2027, with a compound annual growth rate (CAGR) of roughly 7% (source: Fortune Business Insights). The shift toward DPP-4 inhibitors hinges on their favorable safety profile, low hypoglycemia risk, and ease of use, bolstering NESINA's market presence.

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Market Penetration and Adoption Factors

1. Clinical Efficacy and Safety Profile:
NESINA demonstrates comparable glycemic control to other DPP-4 inhibitors, with a low incidence of adverse effects. Its tolerability appeal supports steady adoption among prescribers.

2. Prescriber Acceptance and Guidelines:
Inclusion in guidelines from organizations like the American Diabetes Association (ADA) reinforces acceptance. However, some clinicians prefer combination therapies or newer agents like SGLT2 inhibitors with additional cardiovascular benefits.

3. Competition and Market Share:
While NESINA was one of the earlier entrants, intense competition from JANUVIA and Onglyza has constrained its market share. Market share reports from IQVIA estimate NESINA's global share at roughly 2-3% among DPP-4 inhibitors.

4. Payer Dynamics:
Reimbursement policies influence prescription patterns. NESINA's relatively competitive pricing and prior patent protections have historically supported stable sales but are under threat as generics emerge.

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Patent Status and Generic Competition

1. Patent Expiry Timeline:
Takeda has actively protected NESINA through patents expiring around 2032, with some counterpart patents extending protection via formulation and method-of-use claims. The expiry of key patents exposes NESINA to generic competition, expected to intensify after 2032.

2. Impact of Biosimilars and Generics:
Although generics for alogliptin are yet to enter the market in major regions, impending patent cliffs are likely to precipitate price erosion and reduced revenue. Strategic patent extensions and formulation innovations may temporarily delay generic market entry.

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Financial Performance and Trajectory

1. Revenue Trends:
Since its launch in 2013, NESINA contributed significantly to Takeda’s diabetes franchise. Annual revenues peaked around USD 350 million in 2018 but have shown plateauing and slight declines in subsequent years, partly due to competition and patent expirations.

2. Market Penetration Strategies:
Takeda has utilized educational initiatives, expanded indications, and combination formulations (e.g., alogliptin with metformin) to bolster sales. The introduction of fixed-dose combinations (FDCs)—like Kazano (alogliptin/metformin)—aims to enhance adherence and capture share.

3. R&D and Pipeline Developments:
Takeda continues exploring new formulations and combination therapies. The company invests in expanding indications, including fixed-dose combos suitable for broader patient populations, to prolong NESINA's lifecycle.

4. Revenue Outlook:
Projection models forecast modest CAGR declines of 2-3% over the next five years owing to patent expiries, competitive challenges, and slower market growth in mature regions. However, emerging markets and expanded indications could offset some declines.

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Regulatory and Market Expansion Drivers

1. Geographic Expansion:
While the U.S. remains a primary market, growth in emerging markets like China, India, and Brazil—where T2DM prevalence is increasing—presents growth opportunities. Regulatory approvals in these regions could contribute incremental revenue.

2. Combination Therapies:
Regulatory approvals of alogliptin-based FDCs in multiple markets facilitate market expansion and improve patient adherence, positively influencing sales.

3. Cardiovascular and Renal Benefits:
Recent clinical trials suggest DPP-4 inhibitors, including alogliptin, are cardiovascular-safe; ongoing studies on renal outcomes may lead to label extensions, further reinforcing its positioning.

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Risks and Opportunities

Risks:

• Patent cliffs: Anticipated generic entry post-2032 will trigger revenue erosion.
• Market saturation: Slowing growth due to the expanding use of SGLT2 inhibitors and GLP-1 receptor agonists with superior cardiovascular benefits.
• Pricing pressures: Global reimbursement constraints threaten profit margins.

Opportunities:

• Therapeutic combinations: Developing triple therapy FDCs incorporating NESINA could enhance patient compliance.
• Developing markets: Growing T2DM prevalence offers untapped revenue streams.
• Additional indications: Potential for expanding use in pre-diabetes or as part of combination therapy regimens.

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Conclusion

NESINA's market dynamics are shaped by competitive intensity, patent protections, and evolving treatment paradigms for T2DM. While Takeda has leveraged strategic product placements and combination formulations to sustain revenues, the impending patent expiries around 2032 pose significant challenges. The drug's financial trajectory is expected to see gradual decline unless supported by pipeline innovations and expanded indications. Continuous market assessments, strategic investments in R&D, and global expansion are critical for maintaining its market position.

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Key Takeaways

• Established Presence: NESINA remains a key player in the DPP-4 inhibitor segment, supported by a strong safety profile and brand recognition.
• Competitive Landscape: Market share faces pressure from newer agents and combination therapies offering additional benefits.
• Patent Expiry and Generics: Patent cliffs starting around 2032 will likely lead to significant revenue declines unless mitigated through innovation.
• Expansion Opportunities: Growth in emerging markets and fixed-dose combinations can extend lifecycle and revenue streams.
• Strategic Focus: Investing in pipeline development and expanding indications remains essential for maintaining financial health in a competitive environment.

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FAQs

1. When is NESINA patent protection expected to expire?
Key patents protecting NESINA are scheduled to expire around 2032, after which generic alogliptin is anticipated to enter the market.

2. How does NESINA compare to other DPP-4 inhibitors in terms of market share?
As of recent reports, NESINA holds approximately 2-3% of the global DPP-4 inhibitor market share, behind leaders like JANUVIA, primarily due to earlier market entry and competitive pressures.

3. What strategies are Takeda employing to prolong NESINA’s market relevance?
Takeda is focusing on fixed-dose combination therapies, expanding indications, and targeting emerging markets to enhance patient adherence and extend the drug’s lifecycle.

4. What are the primary risks facing NESINA’s future revenue?
Patent expiries, increased competition, pricing pressures, and the rise of alternative antidiabetic therapies pose significant risks to NESINA’s financial trajectory.

5. Are there any ongoing clinical studies that could influence NESINA's market position?
Yes, clinical trials assessing cardiovascular and renal outcomes may lead to label extensions, potentially enhancing NESINA's appeal, especially in high-risk T2DM patient populations.

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References
[1] Fortune Business Insights. Global Diabetes Treatment Market Size & Trends, 2021-2027.
[2] IQVIA. DPP-4 inhibitor sales data, 2022.
[3] U.S. Food and Drug Administration. Drug Approved Applications, NESINA (alogliptin), 2013.
[4] Clinical trial data repositories and Takeda official communications.