Alogliptin benzoate - Generic Drug Details

What are the generic sources for alogliptin benzoate and what is the scope of patent protection?

Alogliptin benzoate is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and is included in three NDAs. There are four 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:	4
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 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:

REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST

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
Takeda	Phase 4
Celltrion Pharm, Inc.	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	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes			Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-005	Jan 25, 2013		RX	Yes	No			Y
Takeda Pharms Usa	OSENI	alogliptin benzoate; pioglitazone hydrochloride	TABLET;ORAL	022426-004	Jan 25, 2013		DISCN	Yes	No			Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No			Y	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
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-003	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-002	Jan 25, 2013
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271-001	Jan 25, 2013

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/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 alogliptin benzoate

Country	Patent Number	Title	Estimated Expiration
Argentina	048055	DERIVADOS DE PIRIMIDINA COMO INHIBIDORES DE DIPEPTIDIL PEPTIDASA
Argentina	103423	COMPUESTO DE PIRIMIDINA
Austria	E401320
Australia	2004318013	Dipeptidyl peptidase inhibitors
Brazil	PI0418639	inibidores de dipeptidil peptidase

Supplementary Protection Certificates for alogliptin benzoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586571	1490014-6	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922
1084705	C01084705/05	Switzerland		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
1586571	CR 2014 00011	Denmark		PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130923
1586571	PA2014011,C1586571	Lithuania		PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919
1586571	2014/012	Ireland		PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919

Alogliptin Benzoate Market Dynamics and Financial Trajectory (U.S. and Key Ex-U.S. Markets)

Last updated: June 24, 2026

Alogliptin benzoate’s financial trajectory is defined by a shrinking U.S. DPP-4 inhibitor premium as generic and “authorized generic” pressure compresses price, while incremental demand is constrained by slower class growth, formulary preferences for higher-efficacy competitors, and the drug’s role as a second- or later-line add-on in type 2 diabetes. After patent and exclusivity windows closed and generic competition expanded, revenue trends moved from branded growth to erosion-and-stabilization dynamics. In the current landscape, alogliptin benzoate functions primarily as a cost-optimized generic/low-margin brand-legacy product rather than a volume-growth platform.

What is the revenue trajectory of alogliptin benzoate and why did it change?

Short answer: Revenue shifted from branded, label-driven uptake to price erosion once generic entry took hold across major markets. U.S. pricing pressure is the dominant variable; patient demand is steadier because alogliptin is established as an add-on DPP-4 inhibitor, but competitive positioning weakened versus GLP-1 receptor agonists and SGLT2 inhibitors.

Branded-to-generic transition effects

Key market-dynamics drivers that typically govern alogliptin benzoate’s financial trajectory across geographies:

• Formulary substitution: managed-care formularies moved DPP-4 inhibitors from preferred to non-preferred or required-step edits in many segments.
• Class competition: GLP-1 RAs and SGLT2 inhibitors captured both higher persistence and higher average selling price displacement, even when DPP-4s retained access.
• Generic pricing: once generic alogliptin benzoate became widely available, average net price compressed quickly, then stabilized at low single-digit to low-teens discount bands depending on payer mix and contract cadence.

The commercial role of alogliptin in treatment algorithms

Alogliptin benzoate is used for type 2 diabetes management as a DPP-4 inhibitor, typically:

• as monotherapy in selected patients with contraindications or intolerance,
• as add-on to metformin,
• or as add-on to other oral agents, with insulin combination in some protocols.

That makes demand more resilient than “discontinuation-only” brands, but it also limits upside because it competes in a crowded add-on layer rather than owning first-line initiation.

How competitive pressure affects alogliptin benzoate pricing and volumes?

Short answer: Pricing compression comes from generic DPP-4 substitution and “therapeutic class replacement” by GLP-1 and SGLT2 agents, while volumes are capped by guideline movement toward agents with weight and cardiometabolic benefits.

Competitive set dynamics (real-world substitution)

Alogliptin’s competitive pressure can be segmented into two layers:

1. Within-class DPP-4 substitution (same mechanistic niche):
   • generics and authorized generics of DPP-4 inhibitors (including sitagliptin, saxagliptin, linagliptin) create a near-homogeneous pool for payers.
2. Between-class substitution (treatment benefit differentials):
   • GLP-1 RAs and SGLT2 inhibitors draw initiation and escalation, reducing relative incremental demand for DPP-4 inhibitors.

Net price drivers (what moves margins)

• Payer contract pricing: steep discounts after generic parity.
• Channel mix: pharmacy benefit managers and wholesaler allocations reshape ASP/AMP dynamics.
• State Medicaid and tender pricing: tends to align to lowest-cost entries, accelerating erosion.

What market segments drive demand for alogliptin benzoate?

Short answer: Demand is concentrated in patients already established on DPP-4 inhibitors, secondary-line oral therapy populations, and payer lines where cost controls dominate and alternative injectable or higher-priced therapies face utilization management.

Segment map

• Commercial insured: primarily formulary-managed DPP-4 access with step edits; stable but low growth once generics dominate.
• Medicare Part D: DPP-4 inhibitors often remain accessible; switching is driven by contract tiers and plan designs.
• Medicaid: more sensitive to lowest acquisition cost; generic penetration drives margin compression.
• Specialty and endocrinology practices: higher persistence of DPP-4 regimens for stable patients, but slower conversion to new starts when prescribers shift to GLP-1/SGLT2.

What patents and exclusivity mattered for alogliptin benzoate, and when did generic entry risk rise?

Short answer: Financial trajectory hinges on when branded exclusivity ended and when generic alogliptin benzoate launched at scale. Generic entry risk rises around ANDA filing waves tied to listed patents and exclusivity blocks on the U.S. Orange Book.

Why this matters financially

• ANDA approvals and first generic launches create immediate net price drops.
• Follow-on generics worsen pricing further, typically with diminishing returns after multiple competitors enter.
• Authorized generics can delay or blur the effective price gap between “brand” and “generic” depending on contract terms.

U.S. Orange Book status and litigation gates

Without exact Orange Book listings, specific U.S. patent numbers, and the Paragraph IV docket history for alogliptin benzoate in a given dosage form, a precise exclusivity-to-expiration timeline cannot be stated accurately. In practice, investors and litigators treat the Orange Book patent stack as the gating dataset used to model generic entry timing and launch credibility.

What generic entry risks exist for alogliptin benzoate?

Short answer: The principal generic entry risks are tied to:

• patent protection gaps across polymorph, salt, composition, and method-of-use claims,
• data exclusivity or regulatory exclusivity remaining for the listed products,
• and real-world launch readiness, including facility qualification and packaging strength.

Practical risk pattern in DPP-4 inhibitors

For mature molecules, the generic entry question usually shifts from “will generics exist?” to “how fast will ASP settle?” That depends on:

• number of qualified ANDA entrants,
• whether early entrants secure major payer contracts,
• whether supply is constrained (less common after ramp),
• and whether any remaining formulation or manufacturing IP barriers exist.

How does alogliptin benzoate financial performance compare with other DPP-4 inhibitors?

Short answer: Alogliptin benzoate’s financial profile tracks the DPP-4 class: branded decline followed by generic stabilization. Compared with sitagliptin and linagliptin, alogliptin’s commercial peak typically appears smaller and more sensitive to rapid formulary shift after generics expand. Differences come from relative starting share, network contracting, and brand strength at the time generics entered.

Key comparative drivers

• Market share at exclusivity expiry
• Timing of large payer contract wins
• Relative differentiation versus “cardio-renal” competitors
• Brand familiarity in formularies

What formulations and strengths drive market access for alogliptin benzoate?

Short answer: Market access depends on which dosage strengths are stocked and how payers list the product under generic substitution rules. In many mature oral diabetes products, pharmacy adoption concentrates on the most common strengths with straightforward tablet regimens.

Formulary listing behavior

• Formulary preferred status tends to consolidate around the lowest-cost AB-rated options.
• Step therapy and quantity limits are more likely when payers treat DPP-4 inhibitors as interchangeable add-ons.

What regulatory dynamics shape alogliptin benzoate’s sales and pricing?

Short answer: Regulatory dynamics mainly affect the rate of generic availability and interchangeability. Once multiple ANDAs exist, regulatory impact shifts toward pharmacovigilance, quality compliance, and labeling stability rather than “entry prevention.”

U.S. FDA mechanics that affect commercial outcomes

• ANDA approval pathway determines speed of entry.
• Bioequivalence and manufacturing consistency affect supply reliability.
• Label updates can influence payer authorization criteria and continuity of therapy codes used by pharmacy claims systems.

How do payer policies and reimbursement affect alogliptin benzoate affordability and uptake?

Short answer: Payer policies are the dominant driver once generic penetration is established. Plans use tiering and step edits to manage total diabetes drug spend, and DPP-4 inhibitors often remain accessible because clinical switching is feasible, but they rarely lead initiation when GLP-1/SGLT2 are preferred.

Typical reimbursement outcomes

• Lower copays for generics drive persistence but not necessarily incremental starts.
• Prior authorization rules can reduce new use in higher-cost plan tiers.
• Cost-sharing design tends to shift patients toward the lowest-cost AB group available in the formulary.

What litigation and settlement activity typically changes alogliptin benzoate’s competitive timeline?

Short answer: For oral small molecules, the timeline is usually altered by:

• Paragraph IV outcomes that delay first generic launch,
• settlements that cap or stagger launch dates (sometimes with “design-around” or non-infringement positions),
• or absence of enforceable patents that accelerates launch.

Litigation variables that affect financial trajectory

• Timing of court decisions relative to ANDA approval cycles
• Whether settlements include “carve-outs” for certain strengths
• Whether any terms differ by market or manufacturer

Without the specific docket identifiers, settlement dates, and the patent list for alogliptin benzoate’s U.S. product(s), a precise litigation-to-revenue mapping cannot be generated in a way that supports litigation, licensing, or investment decisions.

What licensing and commercialization structures influence alogliptin benzoate’s economics?

Short answer: For legacy branded products, licensing typically matters through:

• authorized generic arrangements,
• manufacturing and supply agreements that affect cost of goods,
• and distribution agreements that influence pharmacy channel coverage.

Commercial structure patterns

• Authorized generics can maintain higher “brand-like” channel continuity while still capturing margin on generic pricing.
• Co-promotion or legacy distribution becomes less meaningful after full generic adoption.

How does alogliptin benzoate affect portfolio value for investors and strategics now?

Short answer: Current value is driven by remaining branded residuals in select accounts, the scale of generic volume, and the stability of low pricing in competitive AB categories. The product is less likely to contribute material growth unless:

• a new formulation extends exclusivity,
• a combination product returns differentiation,
• or a market experiences renewed utilization due to payer reshaping.

Valuation lens used in practice

• Net price runway after each additional generic entrant
• Volume elasticity at copay thresholds
• Contract renewal cadence across PBMs and government accounts
• Supply risk and quality record (affects claim adjudication and disruptions)

Key Takeaways

• Alogliptin benzoate’s financial trajectory is dominated by the shift from branded premium to generic-driven price compression.
• Demand is comparatively stable because DPP-4 inhibitors remain add-on options for patients already on therapy, but incremental growth is capped by payer and guideline movement toward GLP-1 RAs and SGLT2 inhibitors.
• Competitive pressure comes from both within-class DPP-4 generic substitution and between-class therapeutic replacement.
• The most material financial timing events are tied to U.S. Orange Book patent stack resolution, generic entry waves, and settlement or litigation outcomes that affect first-launch credibility.
• Current economic significance is largely low-margin volume capture rather than growth-led premium.

FAQs

1) Is alogliptin benzoate mainly a branded or generic revenue product today?
It is primarily a low-margin generic/legacy brand revenue stream in most major markets after widespread generic availability.

2) What drives switching from alogliptin benzoate to other diabetes drugs?
Payers and clinicians prioritize agents with stronger cardiometabolic outcomes and utilization management that steers prescribers toward GLP-1 RAs/SGLT2 inhibitors.

3) Does alogliptin benzoate have formulation-specific market advantages?
Market access is dominated by AB interchangeability and stocking patterns; any formulation advantages matter mostly for short-term payer exceptions or supply inclusion rather than sustained premium pricing.

4) What is the biggest risk to volume for alogliptin benzoate?
Formulary tightening that reduces DPP-4 inhibitor priority for new starts, plus therapeutic class displacement.

5) How should exclusivity and patent life be modeled for alogliptin benzoate?
Model around Orange Book-listed patents and related exclusivity blocks, then align anticipated ANDA launch waves to payer contract cycles and generic count.

References

No sources were cited because the request requires Orange Book status, patent expiration, litigation, FDA milestones, and market sizing data for alogliptin benzoate that are not provided in the prompt.