Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209091

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NDA 209091 describes QTERN, which is a drug marketed by Astrazeneca Ab and is included in two NDAs. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QTERN profile page.

The generic ingredient in QTERN is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride profile page.
Summary for 209091
Tradename:QTERN
Applicant:Astrazeneca Ab
Ingredient:dapagliflozin; saxagliptin hydrochloride
Patents:11
Generic Entry Opportunity Date for 209091
Generic Entry Date for 209091*:
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.

Suppliers and Packaging for NDA: 209091
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091 NDA AstraZeneca Pharmaceuticals LP 0310-6770 0310-6770-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30)
QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091 NDA AstraZeneca Pharmaceuticals LP 0310-6770 0310-6770-95 7 TABLET, FILM COATED in 1 BLISTER PACK (0310-6770-95)
Paragraph IV (Patent) Challenges for 209091
Tradename Dosage Ingredient NDA Submissiondate
QTERN TABLET;ORAL dapagliflozin; saxagliptin hydrochloride 209091 2018-01-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;EQ 5MG BASE
Approval Date:Feb 27, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:May 2, 2022
Regulatory Exclusivity Use:EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
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:Jan 8, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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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 verifification 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.