Alogliptin benzoate; metformin hydrochloride - Generic Drug Details

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

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

Alogliptin benzoate; metformin hydrochloride has ninety patent family members in forty-one countries.

Three suppliers are listed for this compound.

Summary for alogliptin benzoate; metformin hydrochloride

International Patents:	90
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alogliptin benzoate; metformin hydrochloride
DailyMed Link:	alogliptin benzoate; metformin hydrochloride at DailyMed

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

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; metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Celltrion Pharm, Inc.	Phase 4
Takeda	Phase 4
Seoul National University Hospital	Phase 4

See all alogliptin benzoate; metformin hydrochloride clinical trials

Pharmacology for alogliptin benzoate; metformin hydrochloride

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

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

A10BA	Biguanides
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

Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KAZANO	Tablets	alogliptin benzoate; metformin hydrochloride	12.5 mg/500 mg and 12.5 mg/1000 mg	203414	3	2017-01-25

US Patents and Regulatory Information for alogliptin benzoate; metformin 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	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No	8,900,638		Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes	7,807,689		Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No	7,807,689		Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes	8,900,638		Y

Expired US Patents for alogliptin benzoate; metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013	8,173,663
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013	6,329,404
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013	6,211,205
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013	6,150,384
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013	6,150,384
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013	5,965,584

International Patents for alogliptin benzoate; metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2006298933	DIPEPTIDYL PEPTIDASE INHIBITORS
Portugal	1586571
China	102079743	Dipeptidyl peptidase inhibitors
Japan	2014058547	SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
China	102140090	Dipeptidyl peptidase inhibitors
Malaysia	159203	SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

Supplementary Protection Certificates for alogliptin benzoate; metformin hydrochloride

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
1586571	300640	Netherlands		PRODUCT NAME: ALOGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923
1586571	16/2014	Austria		PRODUCT NAME: ALOGLIPTIN UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/844 (MITTEILUNG) 20130923
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
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
1586571	122014000019	Germany		PRODUCT NAME: VIPIDIA - ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919

Alogliptin benzoate; metformin hydrochloride Market Analysis and Financial Projection

Last updated: April 26, 2026

Market dynamics and financial trajectory for alogliptin benzoate plus metformin hydrochloride

Alogliptin benzoate in combination with metformin hydrochloride is a branded, patent-lived type 2 diabetes regimen whose market trajectory is dominated by (1) generic erosion in the fixed-dose combination (FDC) and (2) payer-driven selection of preferred platforms within diabetes portfolios (DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, and fixed-dose multi-drug regimens). Financial performance has tended to follow a typical branded-to-generic curve: early growth around launch and label expansion, then margin compression as FDC and component generics gained shelf share. Sales dynamics are further shaped by safety and tolerability signals in DPP-4 class usage, competitive intensity from GLP-1 and SGLT2 classes, and regional pricing and reimbursement structures.

What exactly is the product scope?

This analysis covers the FDC “alogliptin benzoate + metformin hydrochloride” (oral tablets). Market size and financial outcomes vary by jurisdiction because approval status, patent landscape, reimbursement lists, and generic entry timing differ across the US, EU5, and emerging markets.

Key product mechanics:

• Alogliptin (DPP-4 inhibitor): glucose-dependent insulin secretion and reduced glucagon release.
• Metformin (biguanide): first-line glucose lowering, durable access on formularies in many markets.
• FDC value proposition: once/twice daily adherence benefit and payer alignment for dual therapy before escalation to injectable regimens.

How does the market behave for DPP-4 + metformin FDCs?

Market dynamics in type 2 diabetes combinations

• Payer preference shifts: In many systems, formularies have moved step-therapy toward GLP-1 RAs and SGLT2 inhibitors for people with specific risk profiles (weight, cardiovascular risk, renal outcomes). DPP-4 inhibitor combos remain relevant for patients needing oral therapy, tolerability fit, or cost containment.
• Generic penetration risk: Metformin is widely generic; alogliptin is less widely generic than metformin but has still experienced generic entry over time in multiple geographies. Once FDCs can be substituted, price pressure becomes structural.
• Substitution logic: Even when prescribers choose a DPP-4 plus metformin combination, substitution typically happens at the FDC level first (if allowed) or at the component level (metformin + DPP-4 separately) when FDC supply or pricing is unfavorable.

Commercial implication

• The revenue line for an alogliptin + metformin FDC usually evolves from branded growth to high discounting and then share erosion once multiple generic SKUs enter.

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What has driven adoption and revenue expansion?

1) Launch sequencing and dual-therapy positioning

Alogliptin + metformin is positioned for patients who do not reach glycemic targets on monotherapy and need an oral, fixed regimen. The typical adoption pattern is:

• initial physician adoption in endocrinology and primary care
• subsequent expansion based on tolerance, titration simplicity, and formulary inclusion

2) Competitive set and switching costs

DPP-4 inhibitors compete against:

• other DPP-4 inhibitors plus metformin FDCs
• metformin plus SGLT2 inhibitors or GLP-1 RAs (where covered)
• oral triple therapies and fixed-dose regimens in some systems

Switching costs stay moderate because the clinical rationale is similar (oral glycemic control), and generic metformin makes the component baseline inexpensive relative to GLP-1/SGLT2 platforms.

3) Label and adherence value

FDC therapy improves adherence metrics versus two separate prescriptions in real-world settings. Where payers cover FDCs with tiering parity to separate generics, uptake can accelerate.

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Where has financial trajectory turned under payer and generic pressure?

1) Structural price compression after generic entry

For DPP-4 + metformin FDCs, the revenue trajectory generally follows three phases:

• Phase A: branded premium (limited generic competition)
• Phase B: discounting (first generic erosion or multi-source pressure)
• Phase C: substitution (FDC switch to generics or component-level substitution)

This pattern is consistent with how metformin-rich fixed regimens behave because metformin’s low marginal cost pulls down the combined product economics after DPP-4 generic availability broadens.

2) Formulary design shifts from “oral DPP-4” to “preferred outcomes”

In multiple regions, payer formularies increasingly route new patients toward:

• GLP-1 RAs (oral or injectable depending on market)
• SGLT2 inhibitors for heart failure and chronic kidney disease populations These shifts do not eliminate DPP-4 usage, but they reduce incremental share growth. As a result, DPP-4 + metformin FDCs tend to become a maintenance option rather than the dominant first escalation.

3) Portfolio reallocation by manufacturers

Once erosion sets in, originators often reallocate resources toward:

• newer formulations
• other diabetes franchises
• biosimilar and non-diabetes pipelines This impacts marketing intensity and contract retention, accelerating share loss in the mid-to-late lifecycle.

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How does the US patent and generic landscape shape revenue?

The financial trajectory for alogliptin + metformin FDC hinges on:

• whether FDC-specific patents cover the combination formulation and dosing
• whether generics enter at the FDC level or at the component level
• whether market authorization includes bioequivalence and substitution eligibility

In practice, even when some combination patents remain, commercial outcomes can still deteriorate once component generics become dominant and prescribers accept separated dosing.

Practical revenue sensitivity points

• FDC exclusivity and product patents: protect brand pricing and reduce immediate substitution
• Switch and substitution rules: determine how quickly wholesalers and pharmacies replace with multi-source products
• Contracting with PBMs: can force steep discounts independent of legal exclusivity

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What do competitive pricing and channel mechanics indicate for margins?

Channel dynamics typical for diabetes oral drugs

• Wholesaler stocking and pharmacy substitution determine near-term volume.
• PBM rebate structures heavily influence net pricing versus headline list price.
• Multi-source procurement compresses gross-to-net.

Margin profile evolution

• During branded dominance, gross margin can support marketing and patient programs.
• After multi-source entry, net prices decline faster than unit volumes rise, leading to margin contraction.
• When DPP-4 + metformin FDCs switch to routine “commodity” procurement, operating margin depends on:
  • remaining exclusivity
  • contract positioning
  • the degree of differentiation versus component dosing

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How does prescribing behavior affect volume in late lifecycle?

Prescribing shifts over time in type 2 diabetes:

• clinicians often start with metformin
• second-line choice increasingly depends on cardiovascular/renal comorbidities and weight goals
• oral DPP-4 combos remain used, but growth tends to come from:
  • cost-sensitive populations
  • patients unable to tolerate GLP-1/SGLT2
  • continuity on stable regimens

Thus, even if volume holds at the class level, an individual branded DPP-4 + metformin FDC generally faces:

• reduced incremental adoption
• higher switch-back to generic component combinations
• increased pressure from alternative fixed-dose or combination products

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What is the likely financial trajectory pattern for alogliptin benzoate + metformin hydrochloride?

Business-case trajectory (generic lifecycle model)

Below is a directional model for how revenue typically moves for an FDC in this category once generic competition begins.

Lifecycle stage	Market condition	Revenue trend	Margin trend	Share trend
Branded growth	Limited generic presence, formulary access improving	Up	Stable to strong	Rising
Erosion	First generics enter, FDC substitution begins	Flat to down	Compresses	Peaks then declines
Multi-source routine	Broad generic availability, PBM pressure	Down steadily	Low	Continues declining

This model is consistent with observed behavior of diabetes oral combination products when DPP-4 inhibitor patents and combination-specific protections are no longer commercially decisive.

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What are the key market forces investors track?

1) Formulary and PBM contracting outcomes

• Net pricing is driven by rebate and formulary placement, not list price.
• A shift from preferred to non-preferred can accelerate the switch to generics.

2) Generic entry timing by region

• The same drug family can show very different revenue declines in different countries depending on entry clocks.

3) Class competition intensity

• GLP-1 RA and SGLT2 inhibitor growth changes the incremental demand for DPP-4 combos.
• DPP-4 + metformin becomes more substitution-prone at the margin.

4) Uptake persistence in comorbidity subgroups

• DPP-4 regimens can remain in chronic use where patients stabilize.
• This supports a base level of revenue even while incremental growth slows.

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Key Takeaways

• Alogliptin benzoate plus metformin hydrochloride behaves like a late-stage branded diabetes FDC once multi-source substitution becomes feasible: revenue declines after generic penetration, margins compress via PBM rebate and net price erosion, and share drifts to component-level generics.
• Market growth is constrained by payer step therapy that favors GLP-1 RA and SGLT2 inhibitor outcomes, reducing incremental demand for DPP-4 combos.
• The financial trajectory is most sensitive to: (1) the timing of FDC and/or component generic entry, (2) formulary preference shifts, and (3) contract discounting dynamics.

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FAQs

1) Is alogliptin benzoate plus metformin hydrochloride usually the dominant option in second-line oral therapy?

No. It typically loses incremental share versus GLP-1 RA and SGLT2 inhibitor platforms in settings where payers prioritize outcomes and comorbidity-driven step therapy.

2) Does metformin generic availability automatically eliminate the branded FDC revenue stream?

Not automatically, but it accelerates price pressure. Once alogliptin also becomes multi-source, component-level substitution reduces the FDC’s pricing power quickly.

3) What matters more for revenue: legal exclusivity or PBM contracting?

PBM contracting and formulary tiering often dominate near-term net pricing outcomes, particularly once generics enter and rebates can be recalibrated rapidly.

4) Why can volumes persist even when revenue falls?

Patients can stay on stable DPP-4 regimens, and class-level use may hold even as branded FDC share declines due to substitution.

5) What is the main commercial risk after generic entry?

FDC-level substitution and component-level reordering at the pharmacy and wholesaler level, which compresses net pricing faster than unit volume can offset.

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References

[1] FDA. “Drug Approval Packages: Alogliptin.” U.S. Food and Drug Administration.
[2] FDA. “Drug Approval Packages: Metformin Hydrochloride.” U.S. Food and Drug Administration.
[3] EMA. “Public Assessment Reports and EPARs for Dipeptidyl Peptidase-4 Inhibitors.” European Medicines Agency.
[4] International Diabetes Federation. “Diabetes Atlas.” International Diabetes Federation.
[5] FDA. “ANDA/Biopharmaceutics Guidance: Bioequivalence Requirements.” U.S. Food and Drug Administration.