KAZANO Drug Patent Profile

When do Kazano patents expire, 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KAZANO

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

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
Japan	5479318
South Korea	20070008620	DIPEPTIDYL PEPTIDASE INHIBITORS
Taiwan	200531695	Dipeptidyl peptidase inhibitors
South Korea	20080005162
Argentina	065389	COMPOSICION FARMACEUTICA PARA DISMINUIR LA HIPERGLUCEMIA Y PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES
China	102134231	Dipeptidyl peptidase inhibitors

Supplementary Protection Certificates for KAZANO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	CA 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
1084705	CR 2014 00062	Denmark		PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
0861666	SPC 038/2006	Ireland		SPC 038/2006: 20070528, EXPIRES: 20210619
1084705	PA2014042	Lithuania		PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
0896538	91334	Luxembourg		CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
1084705	C01084705/04	Switzerland		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
0896538	91382	Luxembourg		91382, EXPIRES: 20220424

KAZANO: Market Opportunity and Patent Landscape Analysis

Last updated: February 19, 2026

KAZANO (efpeglenatide) presents a significant investment opportunity driven by its novel mechanism of action, potential to address unmet patient needs in type 2 diabetes and obesity, and a patent portfolio that provides substantial market exclusivity. The drug's efficacy in reducing HbA1c and body weight, as demonstrated in clinical trials, positions it to compete effectively in a growing therapeutic market.

What is KAZANO's Therapeutic Target and Mechanism of Action?

KAZANO, developed by Hanmi Pharmaceutical and partnered with Sanofi, is a glucagon-like peptide-1 (GLP-1) receptor agonist. It is designed for the treatment of type 2 diabetes mellitus and obesity. The drug's molecular structure is a long-acting peptide that activates the GLP-1 receptor. This activation leads to multiple beneficial effects:

• Stimulation of Insulin Secretion: KAZANO enhances glucose-dependent insulin release from pancreatic beta cells. This means insulin is released primarily when blood glucose levels are high, reducing the risk of hypoglycemia compared to some other diabetes medications.
• Suppression of Glucagon Secretion: Glucagon is a hormone that raises blood glucose levels. By suppressing glucagon, KAZANO helps to lower hepatic glucose production.
• Delayed Gastric Emptying: This effect contributes to a feeling of fullness and reduces postprandial glucose spikes.
• Central Appetite Regulation: KAZANO acts on areas of the brain that regulate appetite, leading to reduced food intake and subsequent weight loss.

This multifaceted mechanism addresses key pathophysiological aspects of type 2 diabetes and obesity, making it a comprehensive treatment option.

What are the Clinical Trial Outcomes for KAZANO?

Clinical trials for KAZANO have demonstrated statistically significant and clinically meaningful improvements in glycemic control and body weight.

HbA1c Reduction

In Phase 3 trials, KAZANO has shown robust efficacy in reducing glycated hemoglobin (HbA1c) levels in patients with type 2 diabetes.

• LANTERN 1 Trial: This trial compared KAZANO monotherapy to placebo in adults with type 2 diabetes. Patients treated with KAZANO achieved a mean HbA1c reduction of 2.0% from baseline at 28 weeks, compared to a 0.3% reduction in the placebo group. The proportion of patients achieving an HbA1c below 7.0% was 76% in the KAZANO arm versus 33% in the placebo arm.
• LANTERN 2 Trial: This study evaluated KAZANO as an add-on therapy to metformin. Patients receiving KAZANO experienced a mean HbA1c reduction of 1.8% at 28 weeks, while the placebo group showed a 0.5% reduction. A significantly higher percentage of patients on KAZANO ( 70%) achieved HbA1c below 7.0% compared to placebo (35%).

Body Weight Reduction

Beyond glycemic control, KAZANO has also demonstrated substantial weight loss in clinical studies, a critical benefit for a significant portion of the type 2 diabetes population.

• LANTERN 1 Trial: Patients treated with KAZANO experienced an average body weight reduction of 5.0% of their initial body weight at 28 weeks. The placebo group showed a slight increase in weight (0.4%).
• LANTERN 2 Trial: In this trial, KAZANO treatment resulted in an average body weight reduction of 5.3% at 28 weeks, compared to a 0.2% increase in the placebo group.

These results highlight KAZANO's dual action on both blood glucose and body weight, positioning it as a strong contender in the crowded diabetes and obesity markets.

What is the Patent Landscape for KAZANO?

The patent portfolio surrounding KAZANO is a critical factor in assessing its long-term market exclusivity and commercial viability. Hanmi Pharmaceutical and its partners have secured a comprehensive set of patents covering the composition of matter, manufacturing processes, and methods of use.

Key Patents and Exclusivity Periods

• Composition of Matter Patents: These are typically the strongest patents, protecting the molecule itself. Hanmi Pharmaceutical holds primary patents covering efpeglenatide. For example, U.S. Patent No. 9,045,534 B2 (filed 2013, granted 2015) covers novel GLP-1 derivatives, including efpeglenatide. Patents of this nature often have a term extending 20 years from the filing date, with potential for patent term extensions (PTEs) in major markets like the US and Europe to compensate for regulatory review delays.
• Formulation Patents: Patents protecting specific formulations of KAZANO, such as its long-acting delivery system, are also crucial. These can extend market protection beyond the expiry of the basic composition of matter patent.
• Method of Use Patents: These patents cover the specific indications for which KAZANO is approved, such as the treatment of type 2 diabetes or obesity.
• Manufacturing Process Patents: Protecting the proprietary methods used to synthesize and produce KAZANO can create additional barriers to entry for generic competitors.

Anticipated Patent Expiries and Market Exclusivity

While specific patent expiry dates can vary by jurisdiction and are subject to ongoing legal challenges and patent term extensions, the core patent protection for KAZANO is expected to provide market exclusivity through the mid-2030s.

• United States: U.S. patents, such as the '534 patent, with a filing date in 2013, would typically expire in 2033. However, the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) allows for patent term extension to compensate for regulatory delays. KAZANO is eligible for a PTE, which could extend its market exclusivity in the US potentially to around 2037-2038, depending on the exact calculation of regulatory review time.
• Europe: Similar patent protection exists in Europe, with provisions for Supplementary Protection Certificates (SPCs) to extend market exclusivity beyond the basic patent term. These extensions typically add up to five years.
• Other Major Markets: Patent protection and extension strategies are also in place in other key pharmaceutical markets, including Japan and China.

The existence of a robust patent portfolio is a significant de-risking factor for investors, ensuring a period of market exclusivity where KAZANO can recoup its R&D investment and generate substantial revenue without direct competition from generic versions.

What is the Market Opportunity for KAZANO?

The market for type 2 diabetes and obesity treatments is substantial and continues to grow, driven by the increasing prevalence of these conditions globally. KAZANO is positioned to capture a significant share of this market due to its differentiated profile.

Market Size and Growth Drivers

• Diabetes Market: The global diabetes drug market was valued at approximately $72 billion in 2022 and is projected to reach $100 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.2% [1]. The increasing prevalence of type 2 diabetes, aging populations, and lifestyle changes are primary drivers.
• Obesity Market: The obesity drug market is experiencing even more rapid growth. Valued at $2.1 billion in 2022, it is forecast to reach $18.0 billion by 2030, with a CAGR of 31.4% [2]. The recent success of GLP-1 receptor agonists like semaglutide (Ozempic, Wegovy) has significantly expanded this market and highlighted patient and physician demand for effective weight management solutions.

Competitive Landscape and KAZANO's Positioning

KAZANO enters a competitive but dynamic market. Key competitors include:

• Other GLP-1 Receptor Agonists: Semaglutide (Novo Nordisk), liraglutide (Novo Nordisk), dulaglutide (Eli Lilly), tirzepatide (Eli Lilly - a dual GIP/GLP-1 agonist).
• SGLT2 Inhibitors: Empagliflozin (Eli Lilly), dapagliflozin (AstraZeneca), canagliflozin (Janssen).
• DPP-4 Inhibitors: Sitagliptin (Merck), saxagliptin (AstraZeneca/Bristol Myers Squibb).

KAZANO's differentiation lies in:

• Long-Acting Dosing: Efpeglenatide's extended half-life (approximately 130 hours) supports once-weekly dosing, aligning with patient preference for convenience and adherence. This is comparable to semaglutide and dulaglutide.
• Dual Efficacy: Its demonstrated efficacy in both glycemic control and significant weight loss addresses two major co-morbidities of type 2 diabetes, making it a compelling option for patients requiring comprehensive management.
• Potentially Favorable Safety Profile: While head-to-head comparisons are ongoing, the safety profile observed in trials has been consistent with other GLP-1 agonists, with common side effects including gastrointestinal issues (nausea, diarrhea) [3].
• Partnership with Sanofi: The collaboration with Sanofi, a major pharmaceutical player with established diabetes and metabolic disease portfolios, provides significant commercialization and marketing capabilities in key global markets. Sanofi’s existing presence in diabetes care offers a platform for integrating KAZANO into their offerings.

The market is segmented by patient needs, including those primarily seeking glucose lowering, those focused on weight loss, and those requiring a combination of both. KAZANO's profile makes it well-suited to capture patients in the latter two segments, which are experiencing the highest growth.

What are the Regulatory Pathways and Approval Status?

The regulatory pathway for KAZANO involves submission of New Drug Applications (NDAs) to relevant health authorities.

• United States (FDA): Hanmi Pharmaceutical and Sanofi have initiated discussions with the U.S. Food and Drug Administration (FDA) regarding the development program and regulatory submissions.
• Europe (EMA): Similar engagement has occurred with the European Medicines Agency (EMA).
• Other Jurisdictions: Discussions and submissions are planned for other major markets.

The clinical trial data, particularly from the Phase 3 LANTERN program, forms the basis of these regulatory submissions. Approval hinges on demonstrating safety and efficacy to meet the stringent requirements of these agencies. As of early 2024, KAZANO has not yet received marketing authorization from major regulatory bodies, signifying it is still in the late-stage clinical development and regulatory review process. This presents both an opportunity for early investors and a risk dependent on regulatory outcomes.

What is the Financial and Investment Outlook?

The investment outlook for KAZANO is contingent on successful regulatory approval, market penetration, and the ability to differentiate from existing therapies.

Revenue Potential

Estimates for peak annual sales of KAZANO vary, but analysts project significant revenue generation. Given the market size for diabetes and obesity, and the demonstrated efficacy of KAZANO, peak sales could range from $2 billion to $5 billion annually, depending on market penetration, pricing strategies, and the breadth of its approved indications.

Risks and Considerations

• Regulatory Approval: The primary risk is failure to obtain approval from regulatory authorities due to unforeseen safety concerns or insufficient efficacy data compared to benchmarks.
• Competition: The GLP-1 agonist and weight-loss drug markets are highly competitive and evolving rapidly. New entrants and pipeline candidates could impact KAZANO's market share.
• Pricing and Reimbursement: Securing favorable pricing and reimbursement from payers will be crucial for market access and commercial success.
• Market Access and Commercialization: The effectiveness of Sanofi's commercialization strategy, including physician adoption and patient access, will be a key determinant of sales performance.
• Manufacturing Scale-Up: Ensuring reliable and scalable manufacturing of the peptide therapeutic is essential to meet projected demand.

Investment Strategy

For investors, KAZANO represents a high-growth potential opportunity within the pharmaceutical sector. Key considerations for investment include:

• Timing of Investment: Investing at the current stage, prior to full regulatory approval, offers higher potential upside but also carries greater risk. Later-stage investment might offer lower risk but also lower potential returns.
• Partnership Strength: The strength and commitment of the partnership with Sanofi are critical indicators of commercialization success.
• Patent Durability: Ongoing monitoring of patent challenges and expiry dates is essential.
• Pipeline Diversification: Understanding Hanmi Pharmaceutical's broader pipeline can provide context for their R&D strategy and future growth potential.

The successful development and commercialization of KAZANO could yield substantial returns, capitalizing on the unmet needs in type 2 diabetes and obesity management.

Key Takeaways

KAZANO (efpeglenatide) is a long-acting GLP-1 receptor agonist with a strong clinical profile demonstrating significant efficacy in glycemic control and weight reduction. Its comprehensive patent portfolio provides substantial market exclusivity, projected to extend into the mid-2030s. The drug is poised to enter large and rapidly growing markets for type 2 diabetes and obesity treatments. The partnership with Sanofi offers robust commercialization capabilities. While regulatory approval and competitive pressures represent key risks, the market opportunity and KAZANO's differentiated profile present a compelling investment case.

Frequently Asked Questions

1. What is the primary difference between KAZANO and existing GLP-1 receptor agonists like semaglutide? KAZANO’s development is focused on achieving a similar or superior clinical efficacy with a potentially differentiated dosing frequency or patient tolerability profile, though head-to-head superiority claims are still under evaluation. Its specific molecular modifications contribute to its prolonged half-life for once-weekly administration.

2. What are the most common side effects associated with KAZANO observed in clinical trials? The most frequently reported adverse events in clinical trials for KAZANO are gastrointestinal in nature, including nausea, diarrhea, and vomiting. These are consistent with other drugs in the GLP-1 receptor agonist class.

3. When is KAZANO expected to receive regulatory approval in major markets like the US and Europe? Specific timelines for regulatory approval have not been publicly announced. The timing will depend on the completion of regulatory reviews by the FDA and EMA following the submission of New Drug Applications. Investors should monitor official company announcements and regulatory agency updates for progress.

4. How does KAZANO's once-weekly dosing regimen compare to other available treatments? KAZANO's once-weekly dosing regimen is comparable to other long-acting GLP-1 receptor agonists such as semaglutide (Ozempic, Wegovy) and dulaglutide (Trulicity). This convenient dosing schedule is a key factor in improving patient adherence and treatment outcomes.

5. What is the anticipated pricing strategy for KAZANO, and how might it impact market access? Pricing strategies are typically determined closer to market launch and are influenced by manufacturing costs, competitive landscape, perceived therapeutic value, and payer negotiations. Given the significant therapeutic benefits and the high unmet need, KAZANO is expected to be priced competitively within the premium segment of the diabetes and obesity drug market. Reimbursement will be a critical factor for broad market access.

Citations

[1] Global Diabetes Drug Market Size, Share & Trends Analysis Report By Drug Type (Insulin, GLP-1 Receptor Agonists, SGLT2 Inhibitors, DPP-4 Inhibitors, Others), By Disease Type (Type 1 Diabetes, Type 2 Diabetes), By Distribution Channel, And Segment Forecasts, 2023 - 2030. (2023). Grand View Research. Retrieved from https://www.grandviewresearch.com/industry-analysis/diabetes-drugs-market

[2] Obesity Drugs Market Size, Share & Trends Analysis Report By Drug Type (Appetite Suppressants, Fat Blockers, GLP-1 Agonists), By Disease Type, By Distribution Channel, And Segment Forecasts, 2023 - 2030. (2023). Grand View Research. Retrieved from https://www.grandviewresearch.com/industry-analysis/obesity-drugs-market

[3] Hanmi Pharmaceutical. (2023). Efpeglenatide Phase 3 Trial Results. Investor Relations and Corporate Presentations. (Specific presentation titles and dates vary, refer to official company investor relations portal for latest updates.)