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Last Updated: November 22, 2024

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 five suppliers. There are four 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 ten drug master file entries for this compound. Five 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:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022271
Generic Entry Date for 022271*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 Padagis Israel Pharmaceuticals Ltd 45802-087 45802-087-65 30 TABLET, FILM COATED in 1 BOTTLE (45802-087-65)
NESINA alogliptin benzoate TABLET;ORAL 022271 NDA AUTHORIZED GENERIC Padagis Israel Pharmaceuticals Ltd 45802-103 45802-103-65 30 TABLET, FILM COATED in 1 BOTTLE (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:Jul 27, 2026
Regulatory Exclusivity Use:REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST
Patent:⤷  Sign UpPatent Expiration:Jun 27, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
Patent:⤷  Sign UpPatent Expiration:Dec 2, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN

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 022271-002 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.