Last Updated: September 24, 2026

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. There are seven 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 two 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:	6

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 27, 2017	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Apr 4, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Start Trial	Patent Expiration:	Jun 16, 2030	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Start Trial	Patent Expiration:	Sep 21, 2028	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 209091

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017	⤷ Start Trial	⤷ Start Trial
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019	⤷ Start Trial	⤷ Start Trial
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-001	Feb 27, 2017	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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