KAZANO Drug Patent Profile

Which patents cover Kazano, and what generic alternatives are available?

Kazano is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in forty-one countries.

The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Kazano

Kazano 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 July 27, 2026. 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.

Indicators of Generic Entry

Summary for KAZANO

International Patents:	90
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Drug Prices:	Drug price information for KAZANO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KAZANO
What excipients (inactive ingredients) are in KAZANO?	KAZANO excipients list
DailyMed Link:	KAZANO at DailyMed

See drug prices for KAZANO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KAZANO

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

NDA:

203414

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 KAZANO

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

Sponsor	Phase
Takeda	Phase 3

See all KAZANO clinical trials

Pharmacology for KAZANO

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

Paragraph IV (Patent) Challenges for KAZANO

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 KAZANO

KAZANO is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on 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.

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	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No			Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes			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			Y

Expired US Patents for KAZANO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013

International Patents for KAZANO

When does loss-of-exclusivity occur for KAZANO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Israel

Japan

Jordan

Malaysia

Morocco

New Zealand

Peru

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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 KAZANO around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	005641	COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLICEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE DIABETES
Argentina	061195	COMPOSICION FARMACEUTICA PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES
Argentina	065389	COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLUCEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES
Argentina	091289	COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLUCEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES
Austria	256463
Austria	438397

Supplementary Protection Certificates for KAZANO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0861666	91298	Luxembourg		91298, EXPIRES: 20210620
0861666	300258	Netherlands		300258, 20160620, EXPIRES: 20210619
0861666	SPC 038/2006	Ireland		SPC 038/2006: 20070528, EXPIRES: 20210619
0861666	07C0006	France		PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
0861666	CA 2007 00001	Denmark
0861666	SPC/GB07/009	United Kingdom		SPC/GB07/009: 20070126

Last updated: June 22, 2026

Kazano (saxagliptin + metformin) market dynamics and financial trajectory

Kazano (saxagliptin/metformin HCl) has limited remaining growth runway because branded DPP-4 demand has shifted toward competitor brands and generics, with pricing pressure building as newer GLP-1 and SGLT2 regimens displace incretin-based therapy in many markets. Financial trajectory is constrained by (1) ongoing generic penetration of metformin and DPP-4 components and (2) persistent payer preference for lower-cost alternatives and combination therapies.

This profile maps the commercial drivers, channel dynamics, and revenue risk that define Kazano’s trajectory, grounded in the drug’s regulatory status and the typical exclusivity/patent-to-generic pathway for combination incretin products.

What is Kazano (saxagliptin/metformin) and how is it used commercially?

Kazano is a fixed-dose combination of saxagliptin (a DPP-4 inhibitor) and metformin (a biguanide) indicated as an adjunct to diet and exercise for glycemic control in type 2 diabetes. In commercial practice, Kazano is positioned as a combination therapy to improve adherence versus separate tablets.

What patient segments drive Kazano demand?

Key demand pools for DPP-4/metformin combinations historically include:

• Patients inadequately controlled on metformin monotherapy and not escalated to injectable incretins.
• Patients switched from DPP-4 monotherapy to combination therapy.
• Adherence-driven preference for single-tablet regimens.

How do formulary and prior authorization affect Kazano volume?

Kazano volume typically tracks:

• Step edits moving from metformin-first to preferred combination products.
• Payer preference for generics of metformin plus generic DPP-4 agents or lower-cost combination brands.
• Placement on tier systems where DPP-4 classes are competed against GLP-1 and SGLT2.

How do DPP-4 inhibitor market dynamics affect Kazano’s growth ceiling?

DPP-4 inhibitors face persistent share pressure from:

• GLP-1 receptor agonists and dual incretin therapies (weight and A1c benefits).
• SGLT2 inhibitors (cardiorenal benefits in payer decision frameworks).
• Lower-cost generic DPP-4 options, which compress branded pricing power.

For a fixed combination like Kazano, these dynamics compound because prescribers often can replicate the regimen using less expensive generics (metformin plus a generic DPP-4) with comparable glycemic outcomes for many patients.

What competitors compete directly with Kazano in fixed-dose combination and class choice?

Kazano’s direct competitive set includes fixed combination products using DPP-4 + metformin (varies by geography and time) and broader diabetes regimen alternatives. Market share is shaped by:

• Brand-to-brand switching within DPP-4 plus metformin combinations.
• Switching from DPP-4 combinations to GLP-1/SGLT2 due to formulary design and clinical pathways.
• Retail and PBM dynamics that price-squeeze branded DPP-4.

When does Kazano lose branded exclusivity and why does that matter financially?

Kazano’s financial trajectory is fundamentally tied to branded exclusivity and patent posture for its fixed-dose combination and components. Once combination-specific protections expire, generic entry typically follows through:

• ANDA pathways for oral combination products
• Label carve-outs or design-around if formulation or method-of-use claims still exist (less common once core composition protections fall)

What does the typical exclusivity timeline imply for Kazano revenue?

In oral fixed-dose combination drugs, the revenue curve commonly follows:

• High dependency on branded pricing and payer access while exclusivity is active.
• Rapid sales dilution once generics enter and PBMs drive tier placement to lower-cost alternatives.
• Residual branded share tied to inertia, prescriber habits, and patient-specific tolerability or dosing fit.

Because Kazano is not positioned as a first-line injectable disruptor, its post-exclusivity phase tends to be more sensitive to generic substitution than higher-differentiation products.

What is the Orange Book status of Kazano and how does it shape generic entry risk?

Kazano’s generic entry risk depends on Orange Book listings that typically cover:

• Composition of matter for saxagliptin and/or metformin salts and their combination
• Formulation and fixed-dose tablet characteristics
• Method-of-use claims tied to dosing regimens (less likely to block generic approval if not actively used or if claims are weak for enforcement)

When Orange Book-listed patents expire or are successfully challenged, ANDA sponsors can launch with “skinny” or full generic labels depending on litigation outcomes.

How do Paragraph IV challenges typically affect Kazano market behavior?

If any combination-specific Kazano patents have faced Paragraph IV challenges, the usual market mechanics are:

• Entry dates create step-function revenue drops.
• Settlement timing often determines the launch window and the size of the penetration wave.
• PBMs adjust copays and tier rules shortly after generic availability.

How have payer and pricing dynamics changed Kazano’s net sales profile?

Net sales erosion in mature diabetes oral therapies generally reflects three linked mechanisms:

1. List price pressure and contract renegotiation after generic availability in the class.
2. Higher effective discounts due to competitive bidding at PBM and health system level.
3. Tier migration that increases patient cost share and reduces persistence.

For a fixed-dose combination, pricing concessions also respond to the “therapeutic interchange” reality: many payers treat metformin + DPP-4 components as substitutable with equivalent dosing, even when delivered as separate products.

What is Kazano’s financial trajectory relative to GLP-1 and SGLT2 competitors?

Kazano’s trajectory is structurally disadvantaged against:

• GLP-1 receptor agonists with strong payer incentives due to weight and cardiovascular benefits.
• SGLT2 inhibitors with cardiorenal outcome-linked formulary placement.

As diabetes treatment pathways evolved toward cardiorenal risk management, oral DPP-4 + metformin regimens have tended to experience:

• Lower incremental patient starts.
• Increased switching to GLP-1/SGLT2 for patients meeting label-eligible risk profiles.
• Greater discounting pressure to maintain formulary placement.

What generic launch scenarios are most realistic for Kazano?

The practical generic scenarios for Kazano are:

• Full generic substitution of the fixed-dose tablet once combination-specific protections expire.
• “Component replication” where payers push metformin generic plus DPP-4 generic despite convenience loss.
• Label-specific barriers, if any, for dosing schedules or specific population claims, typically weaker in practice than composition expirations.

How do manufacturing and IP barriers affect launch speed?

Even with regulatory approval granted, launch timing depends on:

• Tablet formulation manufacturing readiness for fixed-dose products
• Supply chain and distribution onboarding
• Retail and mail availability

However, in mature oral generics, once approval and supply are ready, market penetration is rapid because prescribers and PBMs can immediately substitute.

What patent litigation risks could influence Kazano revenue in the near to mid term?

For Kazano-like combination drugs, litigation impact usually falls into two buckets:

• Settlement-triggered earlier or later launch windows for first generic entrants.
• Post-approval enforcement that may delay subsequent entrants or narrow marketed product scope.

If a combination patent estate has weak enforceability or broad invalidity risk, litigation typically results in faster commercialization of generics, which accelerates revenue erosion.

What geographic dynamics matter for Kazano revenue (US vs ex-US)?

Kazano’s commercial impact depends on where fixed-dose combination approvals exist and how quickly generics were authorized. In major markets, commercial patterns follow:

• US: driven by FDA approval status, Orange Book patent expiry, ANDA litigation and settlement patterns.
• Europe: driven by national reimbursement mechanisms and generics entry timelines.
• Emerging markets: driven by local regulatory pathways and branded-versus-generic mix.

Because fixed-dose combinations are often challenged early once key composition protections expire, US tends to define the most visible revenue cliff events for such products.

How strong is Kazano’s patent estate likely to be from a market perspective?

From a market-dynamics standpoint, the strength that matters commercially is:

• Whether combination-specific patents block ANDAs on a fixed-dose saxagliptin/metformin tablet.
• Whether those patents are still in force relative to expected ANDA entry timing.
• Whether any settlement delays remain to protect branded share.

When combination protections are narrow or have expired, the brand is exposed to fast generic substitution and pricing resets.

Key timeline view: what the revenue curve usually looks like

Branded exclusivity active phase

• Higher price and formulary positioning
• Prescriber comfort with fixed-dose combination dosing
• Net sales growth depends on diabetes patient mix and payer access

Approaching expiry

• PBMs anticipate replacement and tighten contract terms
• Increased prior authorization requirements
• Prescribers shift to preferred alternatives within the DPP-4 + metformin class

Post-expiry / generic entry phase

• Rapid volume dilution as substitution becomes automatic
• Discounting accelerates
• Remaining branded sales rely on switching frictions and small “holdout” prescriber groups

Kazano market outlook: what matters most for next 12–36 months

Kazano’s near-term outlook is dominated by:

• DPP-4 class share trends versus GLP-1 and SGLT2.
• Generic penetration pace for saxagliptin/metformin fixed-dose products.
• PBM tier policy and patient cost-share sensitivity.
• Competitive response from brands with better payer alignment and outcome-focused positioning.

Key takeaways

• Kazano’s growth ceiling is constrained by class-level displacement of DPP-4 therapy toward GLP-1 and SGLT2 regimens and by generic substitution economics.
• The revenue curve is typically defined by combination-specific patent expiry and the speed of generic fixed-dose entry.
• Market share protection depends less on incremental differentiation and more on payer access, contract discounting, and persistence of fixed-dose convenience benefits.
• The most material financial risk is a step-function sales decline after generic availability and rapid PBM tier re-contracting.

FAQs

1) How does Kazano compare with GLP-1 and SGLT2 in payer coverage for type 2 diabetes?

Coverage typically favors GLP-1 and SGLT2 first-line or risk-based pathways due to formulary incentives and outcome narratives, while DPP-4 combinations face tier restrictions once lower-cost options exist.

2) Do generics of saxagliptin or metformin alone reduce Kazano sales even before fixed-dose generics launch?

Yes. Payer “component replication” allows substitution with metformin generic plus a generic DPP-4, reducing the fixed-dose brand’s incremental advantage.

3) What drives Kazano prescription switching patterns when new diabetes therapies enter the formulary?

Switching is driven by tier placement, prior authorization criteria, and patient-specific cardiorenal risk alignment rather than A1c-only outcomes.

4) What product-form differences (dose strength, tablet characteristics) can delay substitution for fixed-dose combinations like Kazano?

Dose strengths, titration fit, and tablet-handling characteristics can create minor substitution friction, but they generally do not prevent substitution once therapeutically equivalent generics are available.

5) What settlement outcomes in generic litigation most directly affect branded revenue?

Settlement terms that govern launch timing of the first authorized generic fixed-dose product and any product-scope restrictions most directly determine the timing and magnitude of revenue dilution.

References (APA)

1. FDA Orange Book database (Drugs@FDA / Orange Book) for saxagliptin/metformin fixed-dose combination patent listings.
2. FDA Drugs@FDA labeling and approval history for Kazano (saxagliptin and metformin HCl).