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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203414


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NDA 203414 describes KAZANO, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KAZANO profile page.

The generic ingredient in KAZANO is alogliptin benzoate; metformin hydrochloride. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alogliptin benzoate; metformin hydrochloride profile page.
Summary for 203414
Tradename:KAZANO
Applicant:Takeda Pharms Usa
Ingredient:alogliptin benzoate; metformin hydrochloride
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203414
Generic Entry Date for 203414*:
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: 203414
Suppliers and Packaging for NDA: 203414
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414 NDA AUTHORIZED GENERIC Padagis Israel Pharmaceuticals Ltd 45802-169 45802-169-72 60 TABLET, FILM COATED in 1 BOTTLE (45802-169-72)
KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414 NDA AUTHORIZED GENERIC Padagis Israel Pharmaceuticals Ltd 45802-211 45802-211-72 60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE;500MG
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:⤷  Try a TrialPatent Expiration:Jun 27, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
Patent:⤷  Try a TrialPatent Expiration:Mar 15, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN

Expired US Patents for NDA 203414

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