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Last Updated: September 21, 2021

DrugPatentWatch Database Preview

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 two 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. Two 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 Generic Entry Opportunity 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 Perrigo New York Inc 45802-169 45802-169-72 60 TABLET, FILM COATED in 1 BOTTLE (45802-169-72)
KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414 NDA Perrigo New York Inc 45802-211 45802-211-72 60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72)
Paragraph IV (Patent) Challenges for 203414
Tradename Dosage Ingredient NDA Submissiondate
KAZANO TABLET;ORAL alogliptin benzoate; metformin hydrochloride 203414 2017-01-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE;500MG
Approval Date:Jan 25, 2013TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Jun 27, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
Patent:⤷  Try it FreePatent Expiration:Mar 15, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
Patent:⤷  Try it FreePatent Expiration:Jun 24, 2025Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 203414

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Baxter
Boehringer Ingelheim
Moodys
McKesson

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.