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Boehringer Ingelheim
UBS
Fuji
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Dow
Daiichi Sankyo
McKinsey
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022350

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NDA 022350 describes ONGLYZA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ONGLYZA profile page.

The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.
Summary for 022350
Tradename:ONGLYZA
Applicant:Astrazeneca Ab
Ingredient:saxagliptin hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022350
Suppliers and Packaging for NDA: 022350
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350 NDA AstraZeneca Pharmaceuticals LP 0310-6100 N 0310-6100-30
ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350 NDA AstraZeneca Pharmaceuticals LP 0310-6100 N 0310-6100-95

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 31, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 5, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING DESCRIBING SAVOR, A PHASE IV TRIAL EVALUATING THE EFFECT OF SAXAGLIPTIN ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR ISCHAEMIC STROKE IN PATIENTS WITH TYPE 2 DIABETES
Regulatory Exclusivity Expiration:Feb 27, 2020
Regulatory Exclusivity Use:PACKAGE INSERT UPDATED WITH RESULTS FROM STUDY CV181168, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF SAXAGLIPTIN ADDED TO DAPAGLIFLOZIN AND METFORMIN
Patent:➤ Try a Free TrialPatent Expiration:Nov 30, 2028Product Flag?YSubstance Flag?Delist Request?

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Federal Trade Commission
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Covington
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