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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Fish and Richardson
Queensland Health
Harvard Business School
Cipla
Daiichi Sankyo
Teva
Citi
McKinsey

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022271

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NDA 022271 describes NESINA, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NESINA profile page.

The generic ingredient in NESINA is alogliptin benzoate. 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 profile page.
Summary for 022271
Tradename:NESINA
Applicant:Takeda Pharms Usa
Ingredient:alogliptin benzoate
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 022271
Suppliers and Packaging for NDA: 022271
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NESINA alogliptin benzoate TABLET;ORAL 022271 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-087 N 45802-087-65
NESINA alogliptin benzoate TABLET;ORAL 022271 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-103 N 45802-103-65

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 6.25MG 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:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC AGENTS SUCH AS METFORMIN

Expired US Patents for NDA 022271

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 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:

Chubb
Moodys
Harvard Business School
Johnson and Johnson
Julphar
Cerilliant
Healthtrust
Mallinckrodt
Covington

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