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 Applications:	644
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
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	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013		DISCN	Yes	No	7,807,689		Y	Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No	8,173,663
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013		RX	Yes	Yes	8,173,663
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013		RX	Yes	No	8,288,539			Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013		RX	Yes	No	7,807,689		Y	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	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013		RX	Yes	No	8,288,539			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	022271-001	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
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013	6,211,205
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013	6,890,898

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/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 ALOGLIPTIN BENZOATE

Country	Patent Number	Title	Estimated Expiration
Spain	2310704
Israel	220480	נגזרות 1-בנזיל-פירימידין-2,4-דיאון כמעכבי דיפפטידיל פפטידאז, שיטה להכנתן, תכשירים רוקחיים המכילים אותן , ושימוש בהן להכנת תרופות (1-benzyl-pyrimidine-2,4-dione derivatives as dipeptidyl peptidase inhibitors, preparation method thereof, pharmaceutical compositions comprising them and use thereof in the preparation of medicaments)
China	102079743	Dipeptidyl peptidase inhibitors
Japan	2006298933	DIPEPTIDYL PEPTIDASE INHIBITORS
Japan	5284967
European Patent Office	1586571	Inhibiteurs de dipeptidyl peptidase (Dipeptidyl peptidase inhibitors)
Eurasian Patent Organization	013427	ИНГИБИТОРЫ ДИПЕПТИДИЛПЕПТИДАЗЫ (DIPEPTIDYL PEPTIDASE INHIBITORS)

Supplementary Protection Certificates for ALOGLIPTIN BENZOATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	92374	Luxembourg		PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923
1084705	C01084705/05	Switzerland		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
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	172 5006-2014	Slovakia		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919
1586571	C01586571/01	Switzerland		PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 62955 22.11.2013
1084705	SPC/GB14/083	United Kingdom		PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1586571	1490014-6	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922

ALOGLIPTIN BENZOATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alogliptin Benzoate

Market Overview

The Alogliptin Benzoate tablet market has emerged as a significant player in the global pharmaceutical industry, particularly in the treatment of type 2 diabetes mellitus. Alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, has gained traction due to its effectiveness in improving glycemic control and its favorable safety profile[1].

Key Drivers of the Market

Rising Prevalence of Diabetes

The primary driver propelling the Alogliptin Benzoate Tablet Market is the escalating global prevalence of type 2 diabetes mellitus. According to the International Diabetes Federation, the number of adults living with diabetes is projected to rise from 463 million in 2019 to 700 million by 2045. This surge in diabetes cases, attributed to factors such as sedentary lifestyles, unhealthy dietary habits, and increasing obesity rates, has created an urgent need for effective and well-tolerated treatment options[1].

Unique Mechanism of Action

Alogliptin's unique mechanism of action as a DPP-4 inhibitor enhances the body's natural ability to lower blood glucose levels through incretin hormones. This approach is both effective and associated with a lower risk of hypoglycemia compared to some other antidiabetic medications, making it a preferred choice for healthcare providers and patients[1].

Emerging Markets

Emerging markets, particularly in Asia, Latin America, and Africa, offer substantial growth opportunities for the Alogliptin Benzoate Tablet Market. Rapid urbanization, lifestyle changes, and increasing diabetes prevalence in these regions have created a growing demand for effective and well-tolerated diabetes treatments. Strategic partnerships, localized manufacturing, and tailored marketing strategies are key to expanding market presence in these regions[1].

Market Size and Projections

Current Market Size

The Alogliptin Market Size was valued at USD 1.2 Billion in 2023. This valuation reflects the drug's increasing adoption and the growing demand for effective diabetes management solutions[3].

Future Projections

The market is expected to reach USD 1.8 Billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2031. This growth is driven by the rising prevalence of type 2 diabetes, the increasing emphasis on managing diabetes-related complications, and the growing awareness among patients of their treatment alternatives[3].

Geographical Segmentation

Asia-Pacific Region

The Asia-Pacific region, particularly countries like Japan, China, India, and South Korea, presents a rapidly growing market for Alogliptin Benzoate tablets. This growth is driven by the rising prevalence of diabetes, improving healthcare access, and increasing awareness of modern diabetes treatments. However, the market in this region faces challenges related to pricing pressures and varying regulatory requirements[1].

Latin America

Latin America, led by countries such as Brazil and Mexico, offers considerable growth potential. The region's growing middle class with increasing access to advanced healthcare treatments and favorable government healthcare policies are driving market growth. However, market penetration varies significantly across different countries due to economic conditions and local pharmaceutical industry dynamics[1].

Financial Trajectory

Cost-Effectiveness

Switching patients from other DPP-4 inhibitors to Alogliptin has been shown to result in cost savings. A study in the UK found that switching to Alogliptin resulted in a median saving of £7.24 per patient-month, highlighting the cost-effectiveness of the drug[2].

Economic Impact

The economic impact of the Alogliptin Benzoate tablet market is significant, as it helps reduce the long-term costs associated with managing diabetes and its complications. By controlling blood glucose levels and improving patient outcomes, Alogliptin Benzoate reduces the incidence of costly diabetes-related complications such as kidney failure, cardiovascular disease, and nerve damage[4].

Investment Opportunities

The increasing demand for effective diabetes treatments creates lucrative investment opportunities in the production, development, and distribution of Alogliptin Benzoate tablets. Pharmaceutical companies are poised to benefit from the expanding market, driven by new therapeutic combinations, formulations, and the development of generic versions[4].

Trends and Innovations

Combination Therapies

The development of combination therapies combining Alogliptin with other diabetes medications, such as Metformin, is a notable trend. These therapies enhance treatment efficacy, improve glucose control, and increase patient compliance by reducing the number of pills patients need to take daily[4].

New Formulations

New formulations of Alogliptin, including extended-release tablets and injectables, are being developed to offer more flexible treatment options. These innovations aim to improve patient adherence to treatment regimens and address specific patient needs, such as difficulty swallowing pills[4].

Digital Health Integration

The integration of digital health technologies with Alogliptin treatment regimens represents another promising opportunity. Developing companion apps for medication adherence, glucose monitoring, and lifestyle management could enhance treatment outcomes and patient engagement, providing valuable real-world data on Alogliptin's effectiveness and safety[1].

Strategic Alliances

Pharmaceutical companies are forming strategic alliances and collaborations to enhance the development and distribution of Alogliptin Benzoate tablets. These partnerships enable faster distribution and better access to the drug in both developed and emerging markets[4].

Future Outlook

The future outlook for the Alogliptin Benzoate Tablet Market is shaped by evolving treatment paradigms, technological advancements, and changing patient demographics. As the global prevalence of type 2 diabetes continues to rise, the demand for effective and well-tolerated antidiabetic medications like Alogliptin is expected to grow. However, this growth potential is tempered by increasing competition from newer drug classes and the entry of generic alternatives in key markets[1].

Personalized Medicine

The increasing focus on personalized medicine in diabetes care is a key trend likely to influence the future of the Alogliptin market. As our understanding of the genetic and metabolic factors influencing diabetes progression and treatment response improves, there is potential for more targeted use of Alogliptin in specific patient subgroups. This could lead to the development of companion diagnostics or biomarkers to identify patients most likely to benefit from Alogliptin treatment[1].

Key Takeaways

• The Alogliptin Benzoate tablet market is driven by the rising global prevalence of type 2 diabetes and the drug's favorable safety and efficacy profile.
• Emerging markets in Asia, Latin America, and Africa offer significant growth opportunities.
• The market is expected to grow from USD 1.2 Billion in 2023 to USD 1.8 Billion by 2031, with a CAGR of 5.2%.
• Combination therapies, new formulations, and digital health integration are key trends shaping the market.
• Strategic alliances and the development of generic versions are driving market expansion.
• The future outlook is promising, with a focus on personalized medicine and continued research and development.

FAQs

What is the primary driver of the Alogliptin Benzoate tablet market?

The primary driver is the escalating global prevalence of type 2 diabetes mellitus, driven by factors such as sedentary lifestyles, unhealthy dietary habits, and increasing obesity rates[1].

How is the market size of Alogliptin Benzoate projected to grow?

The market is expected to grow from USD 1.2 Billion in 2023 to USD 1.8 Billion by 2031, with a CAGR of 5.2% from 2024 to 2031[3].

What are the key trends shaping the Alogliptin Benzoate tablet market?

Key trends include the development of combination therapies, new formulations such as extended-release tablets and injectables, digital health integration, and strategic alliances among pharmaceutical companies[4].

How does Alogliptin Benzoate impact healthcare costs?

Alogliptin Benzoate helps reduce the long-term costs associated with managing diabetes and its complications by controlling blood glucose levels and improving patient outcomes, thereby reducing the incidence of costly diabetes-related complications[4].

What role do emerging markets play in the growth of the Alogliptin Benzoate tablet market?

Emerging markets in Asia, Latin America, and Africa offer substantial growth opportunities due to rapid urbanization, lifestyle changes, and increasing diabetes prevalence. Strategic partnerships and localized manufacturing are crucial for expanding market presence in these regions[1].

Sources

1. Data Horizon Research: Alogliptin Benzoate Tablet Market Size, Share, Growth, Statistics...
2. NCBI: Retrospective Database Analysis Evaluating the Clinical Outcomes...
3. Market Research Intellect: Alogliptin Market Size and Projections
4. Market Research Intellect: Alogliptin Benzoate Tablet Market Size And Projection