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Serving leading biopharmaceutical companies globally:

Chubb
Teva
Chinese Patent Office
Harvard Business School
Johnson and Johnson
Medtronic
Argus Health
Julphar
Queensland Health
Mallinckrodt

Generated: December 15, 2017

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 nine 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:1
Applicant:1
Ingredient:1
Patents:9
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 45802-087-65 30 TABLET, FILM COATED in 1 BOTTLE (45802-087-65)
NESINA alogliptin benzoate TABLET;ORAL 022271 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-103 45802-103-65 30 TABLET, FILM COATED in 1 BOTTLE (45802-103-65)

Summary 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:► 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 Orange Book Patents for NDA: 022271

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-003Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-003Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-002Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-001Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-003Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-001Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-003Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-001Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-002Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms UsaNESINAalogliptin benzoateTABLET;ORAL022271-001Jan 25, 2013► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Chubb
Express Scripts
Accenture
Queensland Health
Covington
Julphar
McKinsey
Baxter

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