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Harvard Business School
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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022426

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NDA 022426 describes OSENI, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are ten patents protecting this drug. Additional details are available on the OSENI profile page.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are nine 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.

Summary for NDA: 022426

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022426

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL 022426 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-238 45802-238-65 30 TABLET, FILM COATED in 1 BOTTLE (45802-238-65)
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL 022426 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-260 45802-260-65 30 TABLET, FILM COATED in 1 BOTTLE (45802-260-65)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE;EQ 15MG BASE
Approval Date:Jan 25, 2013TE:RLD:Yes
Patent:8,288,539Patent Expiration:Mar 15, 2025Product Flag?Substance Flag?YDelist Request?
Patent:8,637,079Patent Expiration:Jun 4, 2029Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Apr 5, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING DESCRIBING EXAMINE, A TRIAL EVALUATING CARDIOVASCULAR ISCHEMIC RISKS ASSOCIATED WITH ALOGLIPTIN USE IN PATIENTS WITH TYPE 2 DIABETES AT HIGH RISK OF ISCHEMIC CARDIOVASCULAR DISEASE

Expired Orange Book Patents for NDA: 022426

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-004Jan 25, 20136,166,042► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 20136,166,043► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-001Jan 25, 20136,303,640► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-005Jan 25, 20136,166,043► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 20136,172,090► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Colorcon
Queensland Health
Daiichi Sankyo
Farmers Insurance
Citi
Medtronic
Teva
Healthtrust
US Department of Justice
Fuji

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 verifification 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.

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