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Last Updated: March 20, 2023

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
Drug Prices for OSENI

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DrugPatentWatch® Estimated Generic Entry Opportunity 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 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 OSENI

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 pioglitazone
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 OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-005 Jan 25, 2013 RX Yes No See Plans and Pricing See Plans and Pricing 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 OSENI

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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08211981
Estimated Expiration: See Plans and Pricing

Austria

Patent: 8227
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0807453
Estimated Expiration: See Plans and Pricing

Canada

Patent: 77201
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08000279
Estimated Expiration: See Plans and Pricing

China

Patent: 1646420
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 992
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0110094
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11264
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 07905
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 009000195
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 099608
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5180
Estimated Expiration: See Plans and Pricing

Patent: 0970726
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 07905
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0125410
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2008003522
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 38188
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0108
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84968
Estimated Expiration: See Plans and Pricing

Patent: 10517937
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 50
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7596
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09008100
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 239
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 169
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9008
Estimated Expiration: See Plans and Pricing

Peru

Patent: 081663
Estimated Expiration: See Plans and Pricing

Poland

Patent: 07905
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 07905
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 592
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 07905
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0905621
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1486091
Estimated Expiration: See Plans and Pricing

Patent: 090109115
Estimated Expiration: See Plans and Pricing

Spain

Patent: 54397
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 53041
Estimated Expiration: See Plans and Pricing

Patent: 0836775
Estimated Expiration: See Plans and Pricing

Patent: 1350143
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 09000317
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 828
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 OSENI around the world.

Country Patent Number Title Estimated Expiration
Luxembourg 91606 See Plans and Pricing
Taiwan I238064 See Plans and Pricing
Japan 2005041885 METHOD FOR REGULATING GLUCOSE METABOLISM, AND REAGENT RELATED THERETO See Plans and Pricing
Cyprus 1111264 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OSENI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586571 PA2014011,C1586571 Lithuania See Plans and Pricing PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919
1084705 PA2014044 Lithuania See Plans and Pricing PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
0896538 08C0008 France See Plans and Pricing PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926
1084705 C01084705/05 Switzerland See Plans and Pricing PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
McKesson
McKinsey
Johnson and Johnson
Dow

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.