Details for Patent: 8,101,209

Which drugs does patent 8,101,209 protect, and when does it expire?

Patent 8,101,209 protects COREG CR and is included in one NDA.

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

This patent has twenty-four patent family members in fourteen countries.

Summary for Patent: 8,101,209

Title:	Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
Abstract:	The invention relates to a microparticulate system for the delayed and controlled release of active principles (AP) whose absorption window in vivo is essentially limited to the upper parts of the gastrointestinal tract, this system being intended for oral administration. The object of the invention is to provide a system ensuring that the AP is released with certainty by means of a dual mechanism of "time-dependent" and "pH-dependent" release. To achieve this object, the invention proposes a multimicrocapsular oral galenical form which is designed so as to guarantee therapeutic efficacy, and in which the release of the AP is governed by a dual release triggering mechanism that is "time-triggering" and "pH-triggering". This system comprises of microcapsules (200 to 600 .mu.m) comprising a core of AP coated with a film (maximum 40% by weight) comprising a hydrophilic polymer A (Eudragit.RTM. L) and a hydrophobic compound B (vegetable wax, melting point=40-90.degree. C.), B/A being between 0.2 and 1.5. These microcapsules have a dissolution behavior in vitro such that, at a constant pH of 1.4, a latency phase of between 1 and 5 hours is observed, followed by a release of the AP, and such that the change from pH 1.4 to pH 6.8 results in a release of the AP without a latency period in vitro.
Inventor(s):	Legrand; Valerie (Lyons, FR), Castan; Catherine (Orlienas, FR), Meyrueix; Remi (Lyons, FR), Soula; Gerard (Meyzieu, FR)
Assignee:	Flamel Technologies (FR)
Application Number:	10/826,690
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,101,209
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form; Delivery;

Drugs Protected by US Patent 8,101,209

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-001	Oct 20, 2006	AB	RX	Yes	No					Y
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006	AB	RX	Yes	No					Y
Woodward	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	AB	RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 8,101,209

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	01 12999	Oct 09, 2001

International Family Members for US Patent 8,101,209

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2002362712
Brazil	0213175
Brazil	PI0213175