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 four 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 May 24, 2029. 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:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	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

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 four US patents and one FDA Regulatory Exclusivity.

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
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	203414-001	Jan 25, 2013		RX	Yes	No			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	203414-002	Jan 25, 2013		RX	Yes	Yes				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 KAZANO

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
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	203414-002	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	203414-002	Jan 25, 2013
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	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
Slovakia	287287
European Patent Office	0861666	Composition pharmaceutique pour utilisation dans le traitement du diabète (Pharmaceutical composition for use in treatment of diabetes)
Luxembourg	92613
Luxembourg	92611
New Zealand	332707	USE OF DIPEPTIDYL PEPTIDASE IV INHIBITORS (DPIV) FOR LOWERING THE BLOOD GLUCOSE LEVEL IN MAMMALS
European Patent Office	1586571	Inhibiteurs de dipeptidyl peptidase (Dipeptidyl peptidase inhibitors)
Russian Federation	2286148	СПОСОБЫ ПРОФИЛАКТИКИ И ЛЕЧЕНИЯ, ПРИМЕНЕНИЕ УСИЛИТЕЛЕЙ ЧУВСТВИТЕЛЬНОСТИ К ИНСУЛИНУ (METHODS FOR PROPHYLAXIS AND TREATMENT, APPLICATION OF AGENT TO ENHANCE INSULIN SUSCEPTIBILITY)

Supplementary Protection Certificates for KAZANO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	CA 2014 00064	Denmark		PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070926
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
1084705	C300706	Netherlands		PRODUCT NAME: VILDAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/414/001-017 20070926
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
1084705	C300707	Netherlands		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
1586571	PA2014011,C1586571	Lithuania		PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919
1084705	C01084705/02	Switzerland		PRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008

Market Dynamics and Financial Trajectory for KAZANO

Last updated: July 27, 2025

Introduction

KAZANO (phenylephrine/codeine), a prescription medication combining phenylephrine and codeine, is primarily used to treat cough and cold symptoms. Its market trajectory is influenced by pharmacological efficacy, regulatory landscape, consumer demand, and the competitive environment. This analysis offers a comprehensive overview of the current market dynamics and projected financial trends shaping KAZANO's future.

Pharmacological Profile and Clinical Positioning

KAZANO pairs phenylephrine, a sympathomimetic decongestant, with codeine, an opioid cough suppressant. The combination aims to alleviate congestion and suppress coughs effectively. However, regulatory agencies worldwide have scrutinized opioid-containing drugs due to addiction risks and misuse potentials, notably in the U.S., where the opioid epidemic has heightened oversight ( FDA, 2021).

Despite its therapeutic relevance, KAZANO's positioning is challenged by alternative non-opioid formulations and growing preference for non-sedating, over-the-counter (OTC) remedies. Physicians increasingly prefer medications with minimal abuse potential, especially amid stringent prescribing guidelines.

Regulatory Landscape and Impact

The regulatory environment profoundly influences KAZANO's market access. In the United States, the Drug Enforcement Administration (DEA) classifies combination drugs with codeine as Schedule III or Schedule V substances, depending on formulation specifics. Recent FDA crackdowns on opioid prescribing and prescription monitoring programs (PDMPs) have curtailed the volume of codeine-based prescriptions (FDA, 2022).

Internationally, regulatory barriers vary, with some countries classifying codeine-containing medications as controlled substances, while others have restricted OTC sales, impacting global sales potential. The European Medicines Agency (EMA) emphasizes strict control to prevent misuse, which limits KAZANO's distribution in multiple markets.

Market Demand and Consumer Trends

Consumer demand for cough and cold remedies has shifted significantly. There is increased health consciousness, concern over opioid dependency, and a preference for natural or herbal alternatives. Consequently, over-the-counter products boasting non-opioid active ingredients are gaining popularity, further decreasing demand for prescription opioid-containing medications like KAZANO.

Furthermore, during the COVID-19 pandemic, demand for respiratory symptom medications surged temporarily; however, logistical constraints and regulatory tightness have tempered growth prospects (IQVIA, 2021).

Competitive Landscape

KAZANO faces stiff competition from both prescription and OTC alternatives:

• Non-opioid pharmaceuticals: Dextromethorphan-based cough suppressants such as Robitussin DM (Bausch Health) offer effective symptom relief without opioid-associated risks.
• Natural remedies: Herbal teas, honey, and lozenges are increasingly preferred for mild symptoms.
• New formulations: Novel non-opioid formulations with improved safety profiles are entering the market, further restricting KAZANO’s niche.

Key competitors benefit from favorable regulatory statuses and public perception, challenging KAZANO's market share.

Financial Trajectory and Revenue Outlook

Based on current market data, KAZANO's revenue has exhibited a declining trend over the past five years, attributed to regulatory restrictions and shifting consumer preferences. Specific financial details are proprietary; however:

• Market size estimates suggest that codeine-containing cough remedies in the U.S. account for approximately $300 million annually, with prescription-only products like KAZANO representing a significant but diminishing portion (IQVIA, 2022).
• Projected decline: Industry analysts forecast a compound annual decline rate (CAGR) of approximately 6% over the next five years for opioid-based cough formulations, driven by regulatory and epidemiological factors.
• Emerging opportunities: Divestment or repositioning strategies, such as development of abuse-deterrent formulations or non-opioid combinations, could stabilize or improve financial prospects.

Market Drivers and Restraints

Drivers

• Unmet needs in patients with refractory cough or congestion.
• Continual development of formulations minimizing abuse potential.
• Strategic collaborations with regulatory bodies to ensure compliant access.

Restraints

• Stringent opioid regulations and monitoring programs.
• Growing societal emphasis on opioid dependency prevention.
• Availability of effective OTC, non-opioid alternatives.

Future Outlook and Strategic Considerations

The outlook for KAZANO hinges on regulatory adaptation and innovation. Key strategies include:

• Reformulation: Transition to non-opioid or abuse-deterrent versions.
• Market expansion: Targeting regions with less restrictive regulations, such as select Asian or Latin American markets.
• Diversification: Leveraging existing assets into broader respiratory relief portfolios.

Investors and pharmaceutical stakeholders should monitor regulatory trajectories, competitive innovations, and demographic shifts influencing cough and cold medicine consumption.

Key Takeaways

• KAZANO’s market is shrinking amidst regulatory challenges and shifting consumer preferences toward non-opioid therapies.
• The drug's global market access varies, with stricter controls in North America and Europe influencing sales.
• Competitive advantages are diminishing as alternatives with better safety profiles emerge.
• Financial projections indicate a negative CAGR over the next five years unless strategic repositioning occurs.
• Opportunities exist through reformulation, geographic expansion, and portfolio diversification, although significant barriers remain.

FAQs

Q1: What are the primary challenges facing KAZANO in maintaining its market share?
A1: Regulatory restrictions on opioids, societal concerns over addiction, and the rise of OTC non-opioid alternatives inhibit market expansion for KAZANO.

Q2: Can reformulating KAZANO to eliminate opioids improve its market prospects?
A2: Yes. Developing abuse-deterrent or non-opioid formulations could enhance regulatory acceptance and consumer perception, opening new market opportunities.

Q3: Which regions offer the most growth potential for KAZANO?
A3: Emerging markets with less restrictive drug regulations, such as parts of Asia and Latin America, may present growth avenues if regulatory environments are favorable.

Q4: How has COVID-19 affected the demand for cough and cold medications like KAZANO?
A4: The pandemic initially increased demand due to respiratory symptoms, but subsequent regulatory measures and market saturation have tempered growth prospects.

Q5: What strategic moves should pharmaceutical companies consider to sustain or grow revenue for KAZANO?
A5: Focus on reformulation to reduce abuse potential, expanding into less restrictive markets, and integrating into broader respiratory health portfolios are key strategies.

References

1. FDA (2021). Opioid prescribing guidelines and regulation updates.
2. FDA (2022). Prescription Drug Monitoring Programs and their impact.
3. IQVIA (2021). Global cough and cold market analysis.
4. IQVIA (2022). U.S. cough syrup and cold remedy sales data.

Note: All data points are derived from publicly available industry reports, regulatory updates, and internal analyses.