Details for Patent: 8,617,599

Which drugs does patent 8,617,599 protect, and when does it expire?

Patent 8,617,599 protects ENVARSUS XR and is included in one NDA.

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

Summary for Patent: 8,617,599

Patent landscape, scope, and claims:

Title:	Modified release compositions comprising tacrolimus
Abstract:	A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s):	Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee:	Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:	13/167,095
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Drugs Protected by US Patent 8,617,599

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No	8,617,599		Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No	8,617,599		Y
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes	8,617,599		Y

Foreign Priority and PCT Information for Patent: 8,617,599

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2003 01232	Aug 29, 2003
Denmark	2003 01837	Dec 11, 2003
Denmark	2004 00079	Jan 21, 2004
Denmark	2004 00463	Mar 23, 2004
Denmark	2004 00467	Mar 23, 2004

International Family Members for US Patent 8,617,599

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	473003
Austria	531368
Australia	2004267909
Australia	2004267910
Brazil	PI0413927