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Details for Patent: 6,500,454

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Which drugs does patent 6,500,454 protect, and when does it expire?

Patent 6,500,454 protects INNOPRAN XL and is included in one NDA.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 6,500,454

Title:	Timed, sustained release systems for propranolol
Abstract:	A unit dosage form, such as a capsule or the like for delivering drugs into the body in a circadian release fashion, is comprising of one or more populations of propranolol-containing particles (beads, pellets, granules, etc.). Each bead population exhibits a pre-designed rapid or sustained release profile with or without a predetermined lag time of 3 to 5 hours. Such a circadian rhythm release cardiovascular drug delivery system is designed to provide a plasma concentration--time profile, which varies according to physiological need during the day, i.e., mimicking the circadian rhythm and severity/manifestation of a cardiovascular disease, predicted based on pharmaco-kinetic and pharmaco-dynamic considerations and in vitro/in vivo correlations.
Inventor(s):	Percel; Phillip J. (Troy, OH), Vishnupad; Krishna S. (Dayton, OH), Venkatesh; Gopi M. (Dayton, OH)
Assignee:	Eurand Pharmaceuticals Ltd. (IE)
Application Number:	09/971,167
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form; Device; Composition; Use; Delivery;

Drugs Protected by US Patent 6,500,454

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Patent Submitted
Ani Pharms Inc	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-001	Mar 12, 2003	BX	RX	No	No			Y
Ani Pharms Inc	INNOPRAN XL	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021438-002	Mar 12, 2003	BX	RX	No	No			Y

Non-Orange Book US Patents Family Members for Patent 6,500,454

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,040,086	Timed, sustained release systems for propranolol
9,358,214	Timed, sustained release systems for propranolol

International Patents Family Members for US Patent 6,500,454

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Norway	335070
Norway	20041740
Mexico	PA04003234
South Korea	101090719