Details for Patent: 8,329,648

Which drugs does patent 8,329,648 protect, and when does it expire?

Patent 8,329,648 protects FARXIGA, BYDUREON, BYDUREON PEN, and BYDUREON BCISE, and is included in three NDAs.

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

This patent has forty-eight patent family members in twenty-five countries.

Summary for Patent: 8,329,648

Title:	Methods for treating diabetes and reducing body weight
Abstract:	Methods for reducing body weight, altering body composition, treating diabetes, reducing HbA.sub.1c and reducing average daily blood glucose by the use of exendins, exendin agonists or exendin analog agonists are provided.
Inventor(s):	Fineman; Mark (San Diego, CA), MacConell; Leigh (San Diego, CA), Taylor; Kristin (San Diego, CA)
Assignee:	Amylin Pharmaceuticals, LLC (San Diego, CA)
Application Number:	13/084,757
Patent Claim Types: see list of patent claims	Use; Composition;

Drugs Protected by US Patent 8,329,648

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	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No						REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No						TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No						REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes						TREATMENT OF TYPE 2 DIABETES MELLITUS IN COMBINATION WITH EXENATIDE
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes						REDUCING FASTING PLASMA GLUCOSE IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes						REDUCING HBA1C IN A HUMAN IN NEED THEREOF IN COMBINATION WITH A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENDIN-4
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No					Y

International Family Members for US Patent 8,329,648

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006283517
Australia	2011200663
Australia	2013205769
Brazil	PI0615358
Canada	2619426
China	101291685
China	105056211