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Generated: January 22, 2019

DrugPatentWatch Database Preview

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 seven 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. Two 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:7
Formulation / Manufacturing:see details
Generic Entry Opportunity 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 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)

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: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:➤ Sign UpPatent 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 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 022271-001 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 022271-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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