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 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for KAZANO?
- What are the global sales for KAZANO?
- What is Average Wholesale Price for KAZANO?
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 |
| 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
*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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid preparation comprising alogliptin and metformin hydrochloride
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-001 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | KAZANO | alogliptin benzoate; metformin hydrochloride | TABLET;ORAL | 203414-002 | Jan 25, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: PREPARACION SOLIDA Y METODO DE PREPARACION
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 08276842
Patent: Solid preparation comprising alogliptin and metformin hydrochloride
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0814299
Patent: PREPARAÇÃO SÓLIDA, E, MÉTODOS PARA ESTABILIZAR UM COMPOSTO EM UMA PREPARAÇÃO SÓLIDA, E PARA PRODUZIR UMA PREPARAÇÃO SÓLIDA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 94620
Patent: PREPARATION SOLIDE (SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1801351
Patent: Solid preparation comprising alogliptin and metformin hydrochloride
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 60301
Patent: PREPARACION SOLIDA QUE CONTIENE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 267
Patent: PREPARACION SOLIDA QUE CONTIENE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 010000028
Patent: PREPARACION SOLIDA QUE CONTIENE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 109979
Patent: PREPARACIÓN SÓLIDA QUE CONTIENE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0870
Patent: ТВЕРДЫЙ ПРЕПАРАТ, ВКЛЮЧАЮЩИЙ АЛОГЛИПТИН И ГИДРОХЛОРИД МЕТФОРМИНА (SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE)
Estimated Expiration: ⤷ Sign Up
Patent: 1070164
Patent: ТВЕРДЫЙ ПРЕПАРАТ, ВКЛЮЧАЮЩИЙ АЛОГЛИПТИН И ГИДРОХЛОРИД МЕТФОРМИНА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 85138
Patent: PREPARATION SOLIDE COMPRENANT DU ALOGLIPTIN ET METFORMIN CHLORHYDRATE (SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE)
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0125672
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3171
Patent: תכשיר מוצק הכולל אלוגליפטין ומטפורמין הידרוכלוריד (Solid preparation comprising alogliptin and metformin hydrochloride)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 79318
Estimated Expiration: ⤷ Sign Up
Patent: 10533643
Estimated Expiration: ⤷ Sign Up
Patent: 14058547
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 72
Patent: مستحضر صلب يشمل ألوجليبتين وميتفورمين هيدروكلوريد (SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 9203
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 592
Patent: PREPARATION SOLIDE COMPRENANT L'ALOGLIPTINE ET LE CHLORHYDRATE DE METFORMINE
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3346
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 090882
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA
Estimated Expiration: ⤷ Sign Up
Patent: 140923
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1000831
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1536786
Estimated Expiration: ⤷ Sign Up
Patent: 100036367
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 03879
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 21102
Estimated Expiration: ⤷ Sign Up
Patent: 0914066
Patent: Solid preparation
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 10000019
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 799
Patent: ТВЕРДЫЙ ПРЕПАРАТ, ВКЛЮЧАЮЩИЙ АЛОГЛИПТИН И ГИДРОХЛОРИД МЕТФОРМИНА;ТВЕРДИЙ ПРЕПАРАТ, ЩО ВКЛЮЧАЄ АЛОГЛІПТИН І ГІДРОХЛОРИД МЕТФОРМІНУ (SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| China | 102134231 | Dipeptidyl peptidase inhibitors | ⤷ Sign Up |
| Japan | 2009137973 | USE OF DIPEPTIDYL PEPTIDASE IV EFFECTOR FOR LOWERING BLOOD GLUCOSE LEVEL OF MAMMAL | ⤷ Sign Up |
| Slovenia | 1586571 | ⤷ Sign Up | |
| Argentina | 061195 | COMPOSICION FARMACEUTICA PARA PROFILAXIS Y TRATAMIENTO DE LA DIABETES | ⤷ Sign Up |
| Eurasian Patent Organization | 020870 | ТВЕРДЫЙ ПРЕПАРАТ, ВКЛЮЧАЮЩИЙ АЛОГЛИПТИН И ГИДРОХЛОРИД МЕТФОРМИНА (SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) | ⤷ Sign Up |
| Ukraine | 85871 | ІНГІБІТОРИ ДИПЕПТИДИЛПЕПТИДАЗИ;ИНГИБИТОРЫ ДИПЕПТИДИЛПЕПТИДАЗЫ (DIPEPTIDYL PEPTIDASE INHIBITORS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KAZANO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1586571 | 2014/012 | Ireland | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 |
| 0861666 | 300258 | Netherlands | ⤷ Sign Up | 300258, 20160620, EXPIRES: 20210619 |
| 1084705 | C300708 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224 |
| 1084705 | C300709 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 |
| 1084705 | CR 2014 00062 | Denmark | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005 |
| 1586571 | 92374 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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