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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Chubb
Boehringer Ingelheim
AstraZeneca
Harvard Business School
Dow
McKesson
Argus Health
QuintilesIMS

Generated: January 20, 2018

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 022426
Tradename:OSENI
Applicant:Takeda Pharms Usa
Ingredient:alogliptin benzoate; pioglitazone hydrochloride
Patents:10
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE;EQ 15MG BASE
Approval Date:Jan 25, 2013TE:RLD:Yes
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
Regulatory Exclusivity Expiration:Jan 25, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ SubscribePatent Expiration:Aug 9, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER

Expired US 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;ORAL 022426-002 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-006 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-006 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-006 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Accenture
Cerilliant
Chubb
Express Scripts
Johnson and Johnson
Merck
Cantor Fitzgerald
Moodys
Argus Health

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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