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Serving hundreds of leading biopharmaceutical companies globally:

UBS
AstraZeneca
US Department of Justice
Mallinckrodt
Julphar
Fuji
Cerilliant
Boehringer Ingelheim
Fish and Richardson

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200678

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NDA 200678 describes KOMBIGLYZE XR, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KOMBIGLYZE XR profile page.

The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
Summary for 200678
Tradename:KOMBIGLYZE XR
Applicant:Astrazeneca Ab
Ingredient:metformin hydrochloride; saxagliptin hydrochloride
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 200678
Ingredient-typeBiguanides
Mechanism of ActionDipeptidyl Peptidase 4 Inhibitors
Suppliers and Packaging for NDA: 200678
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 NDA AstraZeneca Pharmaceuticals LP 0310-6125 N 0310-6125-60
KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678 NDA AstraZeneca Pharmaceuticals LP 0310-6125 N 0310-6125-92

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG;EQ 5MG BASE
Approval Date:Nov 5, 2010TE: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:Jul 13, 2025Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
McKinsey
Cipla
Teva
Colorcon
Citi
US Army
AstraZeneca
Cantor Fitzgerald

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