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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 twelve patents protecting this drug. Additional details are available on the NESINA profile page.

The generic ingredient in NESINA is alogliptin benzoate. There are eight 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 NDA: 022271

Tradename:
NESINA
Applicant:
Takeda Pharms Usa
Ingredient:
alogliptin benzoate
Patents:12
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:No
Patent:8,288,539Patent Expiration:Mar 15, 2025Product Flag?Substance Flag?YDelist Request?
Patent:8,697,125Patent Expiration:Jan 22, 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: 022271

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 20136,303,640► subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 20136,150,383► subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 20136,150,383► subscribe
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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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