Details for Patent: 9,616,028

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Which drugs does patent 9,616,028 protect, and when does it expire?

Patent 9,616,028 protects QTERNMET XR and XIGDUO XR and is included in two NDAs.

Protection for QTERNMET XR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-six patent family members in nineteen countries.

Summary for Patent: 9,616,028

Title:	Bilayer tablet formulations
Abstract:	The present invention relates to bilayer tablet formulations comprising metformin extended release (XR) or reduced mass metformin XR formulation as the first layer, an SGLT2 inhibitor formulation as the second layer, and optionally a film coating. The present invention provides methods of preparing the bilayer tablet formulations and methods of treating diseases or disorders associated with SGLT2 activity employing the bilayer tablet formulations.
Inventor(s):	Admassu Abebe, Kyle Martin, Jatin M. Patel, Divyakant Desai, Peter Timmins
Assignee:	AstraZeneca AB , Bristol Myers Squibb Co
Application Number:	US14/706,077
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,616,028
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form;

Drugs Protected by US Patent 9,616,028

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No					Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No					Y

International Family Members for US Patent 9,616,028

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2498758		301040	Netherlands
European Patent Office	2498758		LUC00152	Luxembourg
European Patent Office	2498758		PA2020003	Lithuania
European Patent Office	2498758		CA 2020 00017	Denmark