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
Summary for OSENI
International Patents: | 101 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Patent Applications: | 51 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OSENI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OSENI |
What excipients (inactive ingredients) are in OSENI? | OSENI excipients list |
DailyMed Link: | OSENI at DailyMed |


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.
Anatomical Therapeutic Chemical (ATC) Classes for OSENI
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
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 | 022426-002 | Jan 25, 2013 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-006 | Jan 25, 2013 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-001 | Jan 25, 2013 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-003 | 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 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 |