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 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
Summary for KAZANO
International Patents: | 89 |
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 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
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.
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 |