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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:	67
Clinical Trials:	14
Patent Applications:	266
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
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013		RX	Yes	No	8,288,539			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	022271-003	Jan 25, 2013	6,150,383
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013	7,078,381
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013	7,459,428
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013	6,890,898
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013	6,150,383

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/002182 Vipidia 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
Norway	2007007
China	1535681
Japan	H10167986	MEDICINE
Russian Federation	2305553	НОВЫЕ ИНГИБИТОРЫ ДИПЕПТИДИЛПЕПТИДАЗЫ IV И ИХ ПРИМЕНЕНИЕ ДЛЯ ПОНИЖЕНИЯ КРОВЯНОГО ДАВЛЕНИЯ (NEW DIPEPTIDYL PEPTIDASE IV INHIBITORS AND USES THEREOF AS HYPOTENSIVE AGENT)
Norway	20004345

Supplementary Protection Certificates for NESINA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	CR 2014 00064	Denmark		PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
1586571	16/2014	Austria		PRODUCT NAME: ALOGLIPTIN UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/844 (MITTEILUNG) 20130923
1084705	C01084705/01	Switzerland		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
1174135	437	Finland
1586571	511	Finland

NESINA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NESINA (Alogliptin)

Introduction

NESINA, also known as alogliptin, is a medication used to manage type 2 diabetes. It belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors, which work by increasing the levels of incretin hormones to enhance the release of insulin when glucose levels are elevated. Here, we will delve into the market dynamics and financial trajectory of NESINA.

Global Diabetes Prevalence and Market Growth

The global antidiabetics market is driven significantly by the increasing prevalence of diabetes, particularly type 2 diabetes. This rise is attributed to factors such as unhealthy diets, sedentary lifestyles, and an aging population. The global antidiabetics market was valued at USD 82.85 billion in 2023 and is expected to grow to USD 263.12 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 12.25% from 2024 to 2033[3].

Key Drivers for NESINA

Several factors contribute to the market dynamics of NESINA:

Increasing Diabetes Cases

The global increase in diabetes cases, especially type 2 diabetes, is a primary driver for the demand of NESINA. As the population ages and lifestyles become more sedentary, the need for effective antidiabetic medications like NESINA grows[1].

Patient-Centered Care

The trend towards patient-centered care encourages healthcare providers to prescribe medications that offer good efficacy with minimal side effects. NESINA's favorable safety profile aligns well with this trend, making it a preferred choice among healthcare providers[1].

Combination Therapy

The practice of combining different classes of antidiabetic medications is on the rise. NESINA is often prescribed in combination with other drugs, such as metformin, providing a synergistic approach to diabetes management. This combination therapy enhances the efficacy of treatment and contributes to the market growth of NESINA[1].

Telehealth and Remote Monitoring

The expansion of telehealth services and remote monitoring is influencing the prescription and adherence to medications like NESINA. This ensures better access and compliance for patients, further boosting the market for NESINA[1].

Clinical Efficacy and Safety

NESINA has been evaluated in numerous clinical trials to assess its efficacy and safety.

Clinical Trials

Approximately 8,500 patients with type 2 diabetes have been treated with NESINA in 14 randomized, double-blind, controlled clinical trials. These trials showed that NESINA has a favorable safety profile with a low incidence of adverse events. For example, the overall incidence of adverse events was 66% in patients treated with NESINA 25 mg, compared to 62% with placebo and 70% with active comparators[2].

Adverse Reactions

Common adverse reactions reported in ≥4% of patients treated with NESINA include nasopharyngitis, headache, and upper respiratory tract infections. Serious adverse events such as pancreatitis and hypersensitivity reactions are rare, occurring in less than 1% of patients[2].

Hypoglycemia Risk

NESINA has a lower risk of hypoglycemia compared to other antidiabetic drugs. In monotherapy studies, the incidence of hypoglycemia was 1.5% with NESINA, significantly lower than with sulfonylureas like glipizide, which had an incidence of 26%[2].

Financial Trajectory

The financial trajectory of NESINA is closely tied to the overall growth of the antidiabetics market.

Market Size and Growth

The antidiabetics market, which includes NESINA, is expected to grow significantly over the next decade. The market size is projected to increase from USD 93 billion in 2024 to USD 263.12 billion by 2033, driven by the increasing prevalence of diabetes and the adoption of new-generation antidiabetic drugs[3].

Sales and Revenue

While specific sales figures for NESINA are not provided, the drug's inclusion in the broader antidiabetics market indicates its contribution to the overall revenue. The market's CAGR of 12.25% from 2024 to 2033 suggests a robust financial trajectory for NESINA and similar antidiabetic medications[3].

Competitive Landscape

NESINA operates within a competitive landscape that includes other DPP-4 inhibitors and various classes of antidiabetic drugs.

Market Share and Utilization

The market share of NESINA and other new-generation antidiabetic drugs has been increasing over the past decade. This growth is driven by their improved efficacy and safety profiles compared to older antidiabetic medications[4].

Pricing and Accessibility

The pricing of NESINA and other antidiabetic drugs can vary significantly across different regions. Policies such as biosimilar switching and foreign-to-domestic price ratios can impact the market dynamics and accessibility of these medications[4].

Conclusion

NESINA, as a DPP-4 inhibitor, plays a significant role in the management of type 2 diabetes. The market dynamics for NESINA are driven by the increasing prevalence of diabetes, patient-centered care trends, and the synergistic benefits of combination therapy. Its favorable safety profile and low risk of hypoglycemia make it a preferred choice among healthcare providers.

Key Takeaways

• Increasing Diabetes Prevalence: The global rise in diabetes cases drives the demand for NESINA.
• Patient-Centered Care: NESINA's favorable safety profile aligns with patient-centered care trends.
• Combination Therapy: NESINA is often used in combination with other antidiabetic medications.
• Telehealth Impact: Telehealth services enhance access and compliance to NESINA.
• Clinical Efficacy and Safety: NESINA has a favorable safety profile with low adverse event rates.
• Financial Growth: The antidiabetics market, including NESINA, is expected to grow significantly by 2033.

FAQs

What is NESINA used for?

NESINA (alogliptin) is used to manage type 2 diabetes by increasing the levels of incretin hormones to enhance insulin release.

What are the common adverse reactions associated with NESINA?

Common adverse reactions include nasopharyngitis, headache, and upper respiratory tract infections.

How does NESINA compare to other antidiabetic drugs in terms of hypoglycemia risk?

NESINA has a lower risk of hypoglycemia compared to sulfonylureas like glipizide.

What is the expected growth of the antidiabetics market, including NESINA?

The antidiabetics market is expected to grow from USD 93 billion in 2024 to USD 263.12 billion by 2033, with a CAGR of 12.25%.

How does telehealth impact the use of NESINA?

Telehealth services and remote monitoring enhance access and compliance to NESINA, contributing to its market growth.

Sources

1. IMARC Group: Alogliptin (Nesina) Manufacturing Plant Report 2024 | Setup Cost.
2. FDA: NESINA (alogliptin) tablets - accessdata.fda.gov.
3. Nova One Advisor: Antidiabetics Market Size | Leading Companies.
4. Canada.ca: Market Intelligence Report: Antidiabetic Drugs, 2012-2021.
5. FDA: NESINA (alogliptin) tablets - accessdata.fda.gov.