Details for Patent: 8,461,105

Which drugs does patent 8,461,105 protect, and when does it expire?

Patent 8,461,105 protects BYDUREON, BYDUREON PEN, BYDUREON BCISE, and FARXIGA, 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 thirty-nine patent family members in twenty-one countries.

Summary for Patent: 8,461,105

Patent landscape, scope, and claims:

Title:	Polymer-based sustained release device
Abstract:	This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Inventor(s):	Wright; Steven G. (Madeira, OH), Christensen; Troy (Mason, OH), Yeoh; Thean (Salem, CT), Rickey; Michael E. (Morrow, OH), Hotz; Joyce M. (Cincinnati, OH), Kumar; Rajesh (Marlborough, MA), Costantino; Henry R. (Woodinville, WA)
Assignee:	Alkermes Pharma Ireland Limited (Dublin, IE)
Application Number:	12/585,574
Patent Claim Types: see list of patent claims	Composition; Use;

Drugs Protected by US Patent 8,461,105

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	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	8,461,105*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	8,461,105*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	8,461,105*PED				Y

International Family Members for US Patent 8,461,105

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005235100
Brazil	PI0509946
Canada	2560874