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Serving leading biopharmaceutical companies globally:

Cerilliant
McKinsey
Merck
Queensland Health
Fuji
US Army
Johnson and Johnson
Colorcon
Moodys
Harvard Business School

Generated: February 20, 2018

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 seven 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 nine 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:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 203414
Ingredient-typeBiguanides
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors
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 N 45802-169-72
KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414 NDA Perrigo New York Inc 45802-211 N 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: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:➤ Try a Free TrialPatent Expiration:Feb 2, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC AGENTS SUCH AS METFORMIN

Expired US Patents for NDA 203414

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Dow
Harvard Business School
Healthtrust
Cerilliant
Baxter
Teva
AstraZeneca
Chinese Patent Office

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