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Last Updated: November 21, 2024

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OSENI Drug Patent Profile


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Which patents cover Oseni, and what generic alternatives are available?

Oseni is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and one patent family members in forty-two countries.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Oseni

Oseni 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 June 4, 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

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Drug patent expirations by year for OSENI
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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OSENI
Generic Entry Date for OSENI*:
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.

US Patents and Regulatory Information for OSENI

OSENI is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OSENI 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 OSENI

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 pioglitazone
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-005 Jan 25, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 OSENI

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-006 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-001 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-001 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OSENI

When does loss-of-exclusivity occur for OSENI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5097
Patent: PREPARACION SOLIDA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 08211981
Patent: Solid preparation comprising alogliptin and pioglitazone
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 88227
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0807453
Patent: PREPARAÇÃO SÓLIDA
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 77201
Patent: PREPARATION SOLIDE COMPRENANT DE L'ALOGLIPTINE ET DE LA PIOGLITAZONE (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 08000279
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UNA PARTE QUE COMPRENDE 2-((6-(3R)-3-AMINO-1-PIPERIDINIL)3,4-DIHIDRO-3-METIL-2,4-DIOXO-1-(2H)-PIRIMIDIN)METIL)BENZONITRILO, AZUCAR O ALCOHOL DE AZUCAR Y UNA SEGUNDA PARTE QUE COMPRENDE PIOGLITAZONA Y AZUC
Estimated Expiration: ⤷  Sign Up

China

Patent: 1646420
Patent: Solid preparation comprising alogliptin and pioglitazone
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 992
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0110094
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 11264
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 07905
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 009000195
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA CINASAS
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 099608
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 5180
Patent: ТВЕРДЫЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ АЛОГЛИПТИН И ПИОГЛИТАЗОН (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷  Sign Up

Patent: 0970726
Patent: ТВЕРДЫЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ АЛОГЛИПТИН И ПИОГЛИТАЗОН
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 07905
Patent: PRÉPARATION SOLIDE COMPRENANT DE L'ALOGLIPTINE ET DE LA PIOGLITAZONE (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0125410
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2008003522
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 38188
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0108
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 84968
Estimated Expiration: ⤷  Sign Up

Patent: 10517937
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 50
Patent: مستحضر صلب (Solid Preparation)
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 7596
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 09008100
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y PIOGLITAZONA. (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 239
Patent: ČVRSTI PREPARAT KOJI SADRŽI ALOGLIPTIN I PIOGLITAZON (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 169
Patent: إعداد متين يحتوي على الالوكليبتين و البيوجليتازون.
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9008
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 081663
Patent: PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTIN Y PIOGLITAZONA
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 07905
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 07905
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 592
Patent: ČVRSTI PREPARAT KOJI SADRŽI ALOGLIPTIN I PIOGLITAZON (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 07905
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0905621
Patent: Solid preparation comprising alogliptin and pioglitazone
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1486091
Estimated Expiration: ⤷  Sign Up

Patent: 090109115
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 54397
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 53041
Estimated Expiration: ⤷  Sign Up

Patent: 0836775
Patent: Solid preparation
Estimated Expiration: ⤷  Sign Up

Patent: 1350143
Patent: Solid preparation
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 09000317
Patent: SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 828
Patent: ТВЕРДАЯ РЕЦЕПТУРА, КОТОРАЯ СОДЕРЖИТ АЛОГЛИПТИН И ПИОГЛИТАЗОН;ТВЕРДА РЕЦЕПТУРА, ЩО МІСТИТЬ АЛОГЛІПТИН І ПІОГЛІТАЗОН (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)
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 OSENI around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1108393 ⤷  Sign Up
Brazil PI0418639 inibidores de dipeptidil peptidase ⤷  Sign Up
Norway 332232 ⤷  Sign Up
Germany 19616486 Verfahren zur Senkung des Blutglukosespiegels in Säugern ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OSENI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1174135 CA 2009 00045 Denmark ⤷  Sign Up
1084705 PA2014045 Lithuania ⤷  Sign Up PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705 PA2014041 Lithuania ⤷  Sign Up PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
1084705 SPC/GB14/082 United Kingdom ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
>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.