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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Covington
Moodys
Argus Health
Baxter
Citi
McKinsey
AstraZeneca
Mallinckrodt

Generated: April 26, 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 eight 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:8
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 N 45802-238-65
OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-260 N 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:➤ Sign UpPatent Expiration:Jun 19, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHODS OF TREATING DIABETESCOMPRISING 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 022426-005 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-002 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
McKesson
Moodys
Chubb
Federal Trade Commission
Citi
US Department of Justice
Argus Health
Cipla

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