DrugPatentWatch Database Preview
OSENI Drug Profile
» See Plans and Pricing
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 five patents protecting this drug.
This drug has one hundred and seventy-two patent family members in forty-five 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.
US ANDA Litigation and 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 eight 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: | 172 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OSENI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OSENI |
| DailyMed Link: | OSENI at DailyMed |
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.
Pharmacology for OSENI
US Patents and Regulatory Information for OSENI
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 | 022426-001 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-003 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-006 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-004 | Jan 25, 2013 | Start Trial | Start Trial |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-006 | Jan 25, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OSENI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2755452 | Start Trial |
| European Patent Office | 2433623 | Start Trial |
| Germany | 19616486 | Start Trial |
| Canada | 2559302 | Start Trial |
| Hong Kong | 1033420 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OSENI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1586571 | 16/2014 | Austria | Start Trial | PRODUCT NAME: ALOGLIPTIN UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/844 (MITTEILUNG) 20130923 |
| 1084705 | CA 2014 00064 | Denmark | Start Trial | PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070926 |
| 1586571 | 132014902238640 | Italy | Start Trial | PRODUCT NAME: ALOGLIPTIN IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(VIPIDIA); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/13/844/001 A EU/1/13/844/027, 20130923 |
| 0861666 | CA 2007 00001 | Denmark | Start Trial | |
| 1174135 | SPC026/2009 | Ireland | Start Trial | SPC026/2009: 20101001, EXPIRES: 20210619 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
