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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:	2
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:

8,900,638

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.

This potential generic entry date is based on patent 8,900,638.

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	7,807,689		Y	Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No	8,173,663
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-002	Jan 25, 2013		RX	Yes	Yes	8,900,638		Y
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013		RX	Yes	No	8,900,638		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	5,965,584
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	203414-002	Jan 25, 2013	5,965,584
Takeda Pharms Usa	KAZANO	alogliptin benzoate; metformin hydrochloride	TABLET;ORAL	203414-001	Jan 25, 2013	6,166,043

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
Norway	2007007
Japan	H10167986	MEDICINE
Austria	E401320
Norway	20004345

Supplementary Protection Certificates for KAZANO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	CR 2014 00064	Denmark		PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
1586571	16/2014	Austria		PRODUCT NAME: ALOGLIPTIN UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/844 (MITTEILUNG) 20130923
1084705	C01084705/01	Switzerland		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
1174135	437	Finland

KAZANO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: KAZANO

Introduction

KAZANO, a fixed-dose combination (FDC) therapy consisting of alogliptin and metformin hydrochloride, is a significant player in the treatment of type 2 diabetes. This article delves into the market dynamics and financial trajectory of KAZANO, highlighting its impact, usage, and economic implications.

Approval and Launch

KAZANO was approved by the U.S. Food and Drug Administration (FDA) in January 2013, along with two other type 2 diabetes therapies, NESINA (alogliptin) and OSENI (alogliptin and pioglitazone)[5].

Indications and Usage

KAZANO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It combines alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, with metformin hydrochloride, a biguanide, in a single tablet. This combination is available in two strengths: 12.5 mg alogliptin with 500 mg metformin HCl and 12.5 mg alogliptin with 1000 mg metformin HCl[4][5].

Market Impact

The introduction of KAZANO and other new-generation antidiabetic drugs has significantly impacted the market dynamics. In Canada, for instance, spending on antidiabetic drugs has outpaced the overall drug market, with new-generation drugs like KAZANO driving this growth. Between 2012 and 2021, the market share for antidiabetic drugs increased from 4.2% to 7.9%, with a substantial increase in cost per capita from $26 to $71[1].

Financial Performance

The financial performance of KAZANO can be inferred from the broader trends in antidiabetic drug spending. While specific financial data for KAZANO is not isolated, the category it belongs to has seen significant growth. For example, DPP-4 inhibitors, which include alogliptin, have shown steady sales. In Canada, sitagliptin, another DPP-4 inhibitor, saw sales increase from $170 million in 2012 to $514 million in 2021[1].

Sales and Revenue

Although detailed sales figures for KAZANO are not provided, the drug's inclusion in the category of new-generation antidiabetic medications suggests it has contributed to the overall growth in this market segment. The combination of alogliptin and metformin in KAZANO offers a convenient and effective treatment option, which likely has attracted a significant patient base and contributed to its revenue.

Competitive Landscape

KAZANO operates in a competitive market with other antidiabetic drugs, including GLP-1 agonists, SGLT-2 inhibitors, and other DPP-4 inhibitors. The market is characterized by a shift towards new classes of drugs, which has driven up costs but also improved treatment outcomes. Provincial biosimilar switching policies and the introduction of new drugs like insulin degludec have also influenced market dynamics[1].

Adverse Events and Safety

The financial trajectory of KAZANO can also be influenced by its safety profile. Common adverse events associated with KAZANO include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain, and urinary tract infection. Serious adverse events such as hepatic failure have been reported, which can impact patient adherence and thus revenue[5].

Regulatory and Economic Factors

Regulatory approvals and economic conditions play crucial roles in the financial performance of pharmaceuticals. The FDA approval of KAZANO in 2013 was a significant milestone, allowing Takeda to commercially launch the drug. Economic factors, including general economic conditions, competitive pressures, and regulatory changes, can affect the drug's market share and revenue[5].

Patient and Market Trends

The increasing prevalence of type 2 diabetes and the need for effective treatment options have driven the demand for drugs like KAZANO. Patient preferences for convenient, once-daily dosing regimens and the combination of two effective medications in one tablet have contributed to its market success.

Conclusion

KAZANO has been a notable player in the antidiabetic drug market since its FDA approval in 2013. Its combination of alogliptin and metformin has made it a preferred treatment option for many patients with type 2 diabetes. The drug's financial trajectory is marked by growth in the antidiabetic drug market, driven by increased spending on new-generation drugs.

Key Takeaways

• Market Growth: Spending on antidiabetic drugs, including KAZANO, has outpaced the overall drug market.
• Combination Therapy: KAZANO combines alogliptin and metformin, offering a convenient and effective treatment option.
• Safety Profile: Common adverse events include upper respiratory tract infections and serious events like hepatic failure.
• Regulatory Impact: FDA approval in 2013 was crucial for its commercial launch.
• Economic Factors: General economic conditions and competitive pressures influence its market share and revenue.

FAQs

Q: What is KAZANO used for? A: KAZANO is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Q: What are the components of KAZANO? A: KAZANO is a fixed-dose combination of alogliptin and metformin hydrochloride.

Q: When was KAZANO approved by the FDA? A: KAZANO was approved by the FDA in January 2013.

Q: What are the common adverse events associated with KAZANO? A: Common adverse events include upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain, and urinary tract infection.

Q: How has KAZANO impacted the antidiabetic drug market? A: KAZANO has contributed to the growth in spending on antidiabetic drugs, particularly in the category of new-generation drugs.

Sources

1. Market Intelligence Report: Antidiabetic Drugs, 2012-2021 - Canada.ca
2. Kazano Price Today - KAZ Price Chart & Market Cap - CoinCodex
3. Oregon Drug Use Review / Pharmacy & Therapeutics Committee - ORPDL
4. Kazano (Alogliptin and Metformin HCl Tablets) - RxList
5. Takeda Receives FDA Approval for Three New Type 2 Diabetes Therapies - PR Newswire