Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Merck
AstraZeneca
Medtronic
McKesson
Dow

Last Updated: August 8, 2022

KAZANO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 eighty-nine 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 seven 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

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for KAZANO
Drug Prices for KAZANO

See drug prices for KAZANO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for KAZANO
Generic Entry Date for KAZANO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
TakedaPhase 3

See all KAZANO clinical trials

Pharmacology 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 four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KAZANO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting KAZANO

Dipeptidyl peptidase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN

Dipeptidyl peptidase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN

Dipeptidyl peptidase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid preparation comprising alogliptin and metformin hydrochloride
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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

Patent: 7557
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08276842
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0814299
Estimated Expiration: See Plans and Pricing

Canada

Patent: 94620
Estimated Expiration: See Plans and Pricing

China

Patent: 1801351
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60301
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 267
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 010000028
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 109979
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0870
Estimated Expiration: See Plans and Pricing

Patent: 1070164
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 85138
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3171
Estimated Expiration: See Plans and Pricing

Japan

Patent: 79318
Estimated Expiration: See Plans and Pricing

Patent: 10533643
Estimated Expiration: See Plans and Pricing

Patent: 14058547
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 72
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9203
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 592
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3346
Estimated Expiration: See Plans and Pricing

Peru

Patent: 090882
Estimated Expiration: See Plans and Pricing

Patent: 140923
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1000831
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1536786
Estimated Expiration: See Plans and Pricing

Patent: 100036367
Estimated Expiration: See Plans and Pricing

Spain

Patent: 03879
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 21102
Estimated Expiration: See Plans and Pricing

Patent: 0914066
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000019
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 799
Estimated Expiration: See Plans and Pricing

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
Georgia, Republic of P20094679 DIPEPTIDYL PEPTIDASE INHIBITORS See Plans and Pricing
Cyprus 1108393 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009011451 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KAZANO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 SPC/GB14/086 United Kingdom See Plans and Pricing PRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928
1084705 CA 2014 00065 Denmark See Plans and Pricing PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
1586571 PA2014011 Lithuania See Plans and Pricing PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844 20130919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
Dow
Mallinckrodt
Merck
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.