Details for Patent: 8,716,251

Which drugs does patent 8,716,251 protect, and when does it expire?

Patent 8,716,251 protects QTERNMET XR, FARXIGA, and QTERN, and is included in three 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 sixty-three patent family members in twenty-eight countries.

Summary for Patent: 8,716,251

Title:	Pharmaceutical formulations containing an SGLT2 inhibitor
Abstract:	Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.
Inventor(s):	Dilbir S. Bindra, Mandar V. Dali, Prakash V. Parab, Jatin M. Patel, Li Tao, Ravindra W. Tejwani, Nipa Vatsaraj, Yongmei Wu
Assignee:	AstraZeneca AB
Application Number:	US13/734,655
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,716,251
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

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Drugs Protected by US Patent 8,716,251

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	8,716,251*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014	AB	RX	Yes	No	8,716,251*PED				Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014	AB	RX	Yes	Yes	8,716,251*PED				Y
Astrazeneca Ab	QTERN	dapagliflozin; saxagliptin hydrochloride	TABLET;ORAL	209091-002	May 2, 2019		DISCN	Yes	No	8,716,251*PED				Y

International Family Members for US Patent 8,716,251

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2139494		PA2020522	Lithuania
European Patent Office	2139494		CA 2020 00035	Denmark
European Patent Office	2139494		301054	Netherlands
European Patent Office	2139494		122020000043	Germany
European Patent Office	2139494		LUC00176	Luxembourg
European Patent Office	2139494		2020C/533	Belgium
European Patent Office	2139494		132020000000115	Italy