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Last Updated: March 26, 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 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:	6

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209091

Generic Entry Date for 209091^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;EQ 5MG BASE
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
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	209091-002	May 2, 2019	⤷ Start Trial	⤷ Start Trial
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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