➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
McKesson
McKinsey
Johnson and Johnson
Dow

Last Updated: May 30, 2020

DrugPatentWatch Database Preview

OSENI Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 thirteen 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

< Available with Subscription >

  Start Trial

Drug patent expirations by year for OSENI
Drug Prices for OSENI

See drug prices for OSENI

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.

Recent Litigation for OSENI

Identify potential future generic entrants

District Court Litigation
Case NameDate
TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD.2018-01-03
TAKEDA PHARMACEUTICAL COMPANY LTD. v. INDOCO REMEDIES LTD.2017-09-20
TAKEDA PHARMACEUTICAL COMPANY LTD. v. TORRENT PHARMACEUTICALS LTD.2017-05-05

See all OSENI litigation

Synonyms for OSENI
Alogliptin / pioglitazone
Alogliptin and pioglitazone
Alogliptin mixture with pioglitazone
Pioglitazone / Alogliptin
S900006090

US Patents and Regulatory Information for OSENI

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   Start Trial   Start Trial Y Y   Start Trial
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 RX Yes No   Start Trial   Start Trial Y Y   Start 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 022426-005 Jan 25, 2013   Start Trial   Start Trial
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 022426-005 Jan 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for OSENI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586571 2014C/010 Belgium   Start Trial PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923
1174135 437 Finland   Start Trial
1084705 PA2014042 Lithuania   Start Trial PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.