KAZANO Drug Patent Profile
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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-one 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: | 91 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 1 |
Patent Applications: | 2 |
Formulation / Manufacturing: | see details |
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 |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
Takeda | Phase 3 |
Pharmacology for KAZANO
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KAZANO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid preparation comprising alogliptin and metformin hydrochloride
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting KAZANO
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
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>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: ⤷ Try a Trial
Australia
Patent: 08276842
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0814299
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 94620
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1801351
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 60301
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 267
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 010000028
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 109979
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 0870
Estimated Expiration: ⤷ Try a Trial
Patent: 1070164
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 85138
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0125672
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3171
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 79318
Estimated Expiration: ⤷ Try a Trial
Patent: 10533643
Estimated Expiration: ⤷ Try a Trial
Patent: 14058547
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 72
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 9203
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 592
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 3346
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 090882
Estimated Expiration: ⤷ Try a Trial
Patent: 140923
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1000831
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1536786
Estimated Expiration: ⤷ Try a Trial
Patent: 100036367
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 03879
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 21102
Estimated Expiration: ⤷ Try a Trial
Patent: 0914066
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 10000019
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 799
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Colombia | 6160301 | PREPARACION SOLIDA QUE CONTIENE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA | ⤷ Try a Trial |
Morocco | 28469 | INHIBITEURS DE LA DIPEPTIDYLE PEPTIDASE | ⤷ Try a Trial |
European Patent Office | 2433623 | ⤷ Try a Trial | |
Japan | 4948298 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005095381 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KAZANO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1084705 | C01084705/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008 |
1586571 | 2014C/010 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923 |
1586571 | 252 5006-2014 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: ALOGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130923 |
1586571 | 300640 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALOGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923 |
1586571 | 122014000019 | Germany | ⤷ Try a Trial | PRODUCT NAME: VIPIDIA - ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |