DrugPatentWatch Database Preview
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 five patents protecting this drug.
This drug has one hundred and seventy-four 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.
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 seven 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: | 174 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (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 |
| 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.
Pharmacology for OSENI
Anatomical Therapeutic Chemical (ATC) Classes for OSENI
US Patents and Regulatory Information for OSENI
OSENI is protected by five US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of OSENI is ⤷ Try it Free.
This potential generic entry date is based on patent ⤷ Try it Free.
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
Pharmaceutical composition
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHODS OF TREATING DIABETESCOMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Dipeptidyl peptidase inhibitors
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Solid preparation comprising alogliptin and pioglitazone
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
| 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 | 022426-003 | Jan 25, 2013 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-003 | Jan 25, 2013 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-004 | Jan 25, 2013 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| >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 | 022426-002 | Jan 25, 2013 | ⤷ Try it Free | ⤷ Try it Free |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-002 | Jan 25, 2013 | ⤷ Try it Free | ⤷ Try it Free |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426-005 | Jan 25, 2013 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OSENI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 122009000064 | ⤷ Try it Free |
| Germany | 122007000038 | ⤷ Try it Free |
| Chile | 2008000279 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OSENI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0896538 | 07C0035 | France | ⤷ Try it Free | 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 |
| 1084705 | CR 2014 00064 | Denmark | ⤷ Try it Free | PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928 |
| 1586571 | 92374 | Luxembourg | ⤷ Try it Free | PRODUCT NAME: ALOGLIPTIN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE. FIRST REGISTRATION: 20130923 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
