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Last Updated: April 22, 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
Drug Prices for OSENI

See drug prices for OSENI

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 ⤷  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 OSENI

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 pioglitazone
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 022426-003 Jan 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-005 Jan 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 08211981
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 88227
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0807453
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 77201
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 08000279
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1646420
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 992
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0110094
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 11264
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 07905
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 009000195
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 099608
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 5180
Estimated Expiration: ⤷  Try a Trial

Patent: 0970726
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 07905
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0125410
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2008003522
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 38188
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0108
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 84968
Estimated Expiration: ⤷  Try a Trial

Patent: 10517937
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 50
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7596
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 09008100
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 239
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 169
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9008
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 081663
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 07905
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 07905
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 592
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 07905
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0905621
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1486091
Estimated Expiration: ⤷  Try a Trial

Patent: 090109115
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 54397
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 53041
Estimated Expiration: ⤷  Try a Trial

Patent: 0836775
Estimated Expiration: ⤷  Try a Trial

Patent: 1350143
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 09000317
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 828
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 OSENI around the world.

Country Patent Number Title Estimated Expiration
Australia 766219 ⤷  Try a Trial
China 102127057 Dipeptidyl peptidase inhibitors ⤷  Try a Trial
Japan 4068118 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OSENI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 PA2014045 Lithuania ⤷  Try a Trial PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
0896538 07C0035 France ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
1586571 C01586571/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 62955 22.11.2013
>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.