Alogliptin benzoate; pioglitazone hydrochloride - Generic Drug Details

What are the generic sources for alogliptin benzoate; pioglitazone hydrochloride and what is the scope of freedom to operate?

Alogliptin benzoate; pioglitazone hydrochloride is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate; pioglitazone hydrochloride has one hundred and one patent family members in forty-two countries.

Two suppliers are listed for this compound.

Summary for alogliptin benzoate; pioglitazone hydrochloride

International Patents:	101
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alogliptin benzoate; pioglitazone hydrochloride
DailyMed Link:	alogliptin benzoate; pioglitazone hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for alogliptin benzoate; pioglitazone hydrochloride

Constraining patent/regulatory exclusivity:

8,637,079

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; pioglitazone hydrochloride

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; pioglitazone hydrochloride clinical trials

Pharmacology for alogliptin benzoate; pioglitazone hydrochloride

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Peroxisome Proliferator Receptor alpha Agonist Peroxisome Proliferator Receptor gamma Agonist Thiazolidinedione
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Peroxisome Proliferator-activated Receptor alpha Agonists Peroxisome Proliferator-activated Receptor gamma Agonists

Anatomical Therapeutic Chemical (ATC) Classes for alogliptin benzoate; pioglitazone hydrochloride

A10BG	Thiazolidinediones
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for alogliptin benzoate; pioglitazone hydrochloride

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	022426-001	Jan 25, 2013		RX	Yes	No	8,173,663
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-001	Jan 25, 2013		RX	Yes	No	8,637,079		Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013		RX	Yes	Yes	8,288,539			Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013		DISCN	Yes	No	8,288,539			Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013		RX	Yes	No	8,288,539			Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No	7,807,689		Y	Y

Expired US Patents for alogliptin benzoate; pioglitazone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013	6,329,404
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013	7,459,428
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-006	Jan 25, 2013	6,150,384
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-002	Jan 25, 2013	6,150,383
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013	6,303,661
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-003	Jan 25, 2013	6,890,898

International Patents for alogliptin benzoate; pioglitazone hydrochloride

Country	Patent Number	Title	Estimated Expiration
New Zealand	549716	Pyrimidin-dione derivatives as dipeptidyl peptidase inhibitors
Norway	2014004
Morocco	31169
Germany	602008003522
Malaysia	146290	DIPEPTIDYL PEPTIDASE INHIBITORS
Jordan	2650

Supplementary Protection Certificates for alogliptin benzoate; pioglitazone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	2014/012	Ireland		PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705	CR 2014 00066	Denmark		PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
1586571	C 2014 011	Romania		PRODUCT NAME: ALOGLIPTIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/844/001 - EU/1/13/844/027; DATE OF NATIONAL AUTHORISATION: 20130919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/844/001 - EU/1/13/844/027; DATE OF FIRST AUTHORISATION IN EEA: 20130919
1084705	C01084705/05	Switzerland		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
1586571	132014902238640	Italy		PRODUCT NAME: ALOGLIPTIN IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(VIPIDIA); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/13/844/001 A EU/1/13/844/027, 20130923
1084705	C300709	Netherlands		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Alogliptin Benzoate and Pioglitazone Hydrochloride

Last updated: July 27, 2025

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Introduction

The global pharmaceutical landscape is significantly shaped by the development and commercialization of antidiabetic medications. Among these, Alogliptin Benzoate and Pioglitazone Hydrochloride stand out due to their therapeutic roles in managing Type 2 Diabetes Mellitus (T2DM). This analysis explores the current market dynamics influencing these drugs, their financial trajectories, and future outlooks, offering comprehensive insights that aid stakeholders in strategic decision-making.

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Market Overview

Alogliptin Benzoate

Alogliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor developed as an oral antihyperglycemic agent. Approved by the FDA in 2013, it belongs to a class that enhances incretin hormone levels, thereby increasing insulin synthesis and slowing glucagon release.

The drug is marketed primarily under the brand Nesina and distributed globally, with significant prescriptive use in North America, Europe, and Asia-Pacific. Its market appeal stems from its favorable tolerability profile and weight-neutral effects compared to other antidiabetics.

Pioglitazone Hydrochloride

Pioglitazone, a thiazolidinedione (TZD), was launched in the late 1990s, with the brand Actos (by Takeda Pharmaceuticals). It acts as an insulin sensitizer, improving glycemic control by activating peroxisome proliferator-activated receptor gamma (PPAR-γ). Despite its proven efficacy, concerns over adverse effects—specifically weight gain, edema, and potential cardiovascular risks—have impacted its market penetration.

Pioglitazone remains a cornerstone in treatment algorithms but has experienced market fluctuations due to safety concerns and regulatory limitations, especially in Europe and parts of Asia.

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Market Dynamics

Drivers

1. Growing Prevalence of T2DM
   The global diabetic population is projected to reach 700 million by 2045, fueled by urbanization, sedentary lifestyles, and escalating obesity rates [1]. This surge amplifies demand for effective antidiabetic therapies, boosting the markets for both alogliptin and pioglitazone.

2. Pipeline Innovation and Enhancements
   Ongoing research into combination therapies (e.g., DPP-4 inhibitors with other agents) enhances therapeutic options, fostering market expansion. The development of fixed-dose combinations (FDCs) involving alogliptin improves patient adherence and reduces pill burden.

3. Regulatory Favorability and Cost-Efficiency
   Patent expirations and generic manufacturing have made pioglitazone more accessible and cost-effective, particularly in emerging markets. Regulatory agencies' evolving safety profiles, notably for pioglitazone, influence prescribing patterns but still maintain a significant market share where benefits outweigh risks.

4. Growing Awareness and Screening Programs
   Increased screening and early diagnosis contribute to higher initiation rates of antidiabetic medications, expanding market opportunities.

Challenges

1. Safety Concerns and Regulatory Restrictions

   • Pioglitazone has faced regulatory scrutiny following studies linking it to bladder cancer, leading to usage restrictions in some jurisdictions [2].

   • Alogliptin has a comparatively favorable safety profile, but reports of pancreatitis and joint pain have emerged, warranting cautious prescribing.

2. Market Competition and Evolving Treatment Paradigms

   The rise of SGLT2 inhibitors, GLP-1 receptor agonists, and combination therapies has diversified treatment options, diluting the market share of traditional agents.

3. Pricing Pressures

   Pricing strategies are under pressure from payers, especially in markets favoring generics, leading to squeezed profit margins.

4. Patient-Centric Trends

   Increased focus on weight management and cardiovascular outcomes incentivize the use of newer, more targeted agents, impacting demand for older drugs like pioglitazone.

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Financial Trajectory Analysis

Alogliptin Benzoate

• Revenue Trends:
  Since its market debut, alogliptin has exhibited steady growth, driven by expanding indications and combination formulations. The drug's global sales are projected to reach $1.2 billion by 2025, with a Compound Annual Growth Rate (CAGR) of approximately 6% (2021–2025)[3].

• Market Share:
  Alogliptin's market share remains modest relative to leaders like sitagliptin and linagliptin but is poised to grow through strategic collaborations and lifecycle management.

• Patent and Market Exclusivity:
  Patent protections extend until approximately 2027 in major markets, after which biosimilar entrants are expected to significantly alter the landscape, reducing pricing and margins.

Pioglitazone Hydrochloride

• Revenue Trends:
  Post-2010, revenues experienced a decline due to safety concerns and regulatory actions, notably in Europe and the UK. However, in markets with fewer restrictions and high diabetes prevalence, sales persist at approximately $600 million annually.

• Market Segments:
  The drug's popularity persists in low- and middle-income countries, where it remains a cost-effective option despite safety debates.

• Patent Status and Generics:
  Patent expiration in most markets has facilitated a surge in generic manufacturing, leading to competitive pricing and wider availability.

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Future Outlook

Alogliptin Benzoate

The future of alogliptin hinges on lifecycle management, including:

• Expansion into combination therapies with SGLT2 inhibitors and GLP-1 receptor agonists.
• Market penetration in emerging economies, leveraging affordability and tolerability.
• Potential biosimilar development post-patent expiry, intensifying competition but also reducing entry barriers for generic manufacturers.

Emerging data supporting cardiovascular and renal benefits may bolster its profile, aligning with recent trends favoring comprehensive cardiovascular risk management in T2DM.

Pioglitazone Hydrochloride

Its trajectory faces significant headwinds:

• Growing safety concerns will likely constrain usage in developed regions.
• In emerging markets, ongoing demand persists due to economic factors and established efficacy.
• Innovator companies may seek repositioning or combination formulations to mitigate safety profile issues and regain market relevance.

Overall, pioglitazone’s market presence is expected to decline gradually, overshadowed by newer agents with better safety profiles and added benefits.

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Strategic Recommendations for Stakeholders

• Pharmaceutical Companies:
  Invest in lifecycle management strategies for alogliptin, including combination therapies and expanding indications. For pioglitazone, focus on markets with less regulatory restriction and explore repositioning to mitigate safety concerns.

• Investors:
  Monitor patent expiration timelines, regulatory developments, and emerging clinical data influencing market demand.

• Regulatory Bodies:
  Enforce safety monitoring and communicate updated guidelines to optimize therapeutic outcomes.

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Key Takeaways

• The global T2DM epidemic fuels sustained demand for antihyperglycemics, including alogliptin and pioglitazone.
• Alogliptin exhibits a steady growth trajectory driven by its favorable safety profile, expansion into combination therapies, and pipeline innovations.
• Pioglitazone faces declining demand in developed markets due to safety concerns but remains relevant in cost-sensitive and emerging markets.
• Patent expirations and biosimilar entry will intensify price competition, impacting revenue streams.
• Future success depends on strategic lifecycle management, regulatory navigation, and alignment with evolving clinical guidelines emphasizing cardiovascular and renal benefits.

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FAQs

1. What distinguishes alogliptin from other DPP-4 inhibitors?
   Alogliptin offers a comparable safety and efficacy profile to other agents in its class, with the added benefit of cardiovascular safety data from major trials, making it suitable for patients at risk of cardiovascular disease.

2. Why has pioglitazone's use declined in some regions?
   Concerns over adverse effects, particularly bladder cancer risk and weight gain, have led regulatory agencies like the EMA to restrict its use, reducing market share.

3. Can alogliptin be combined with other antidiabetic medications?
   Yes, fixed-dose combinations with agents like metformin have been developed, enhancing adherence and simplifying treatment regimens.

4. What impact will patent expirations have on the market?
   Patent expiration opens the market for biosimilars and generics, leading to price reductions, increased accessibility, and increased competition.

5. Are there safety advantages of alogliptin over pioglitazone?
   Generally, yes. Alogliptin has a lower risk profile regarding weight gain and edema, making it more suitable for some patient populations, particularly those with cardiovascular risks.

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References

[1] International Diabetes Federation. The Diabetes Atlas, 9th Edition, 2019.

[2] European Medicines Agency (EMA). "Pioglitazone-containing medicines: safety update," 2018.

[3] IQVIA. Global Diabetes Market Data, 2022.

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By understanding these drugs' market dynamics and financial trajectories, stakeholders can better anticipate shifts, make informed investments, and optimize clinical strategies aligned with evolving regulatory and market landscapes.