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Details for Patent: 8,101,209

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Patent 8,101,209 protects COREG CR and is included in one NDA. There have been three Paragraph IV challenges on Coreg CR.

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

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 Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Delivery;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 358th percentile
Forward Citations: 10th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Smithkline Beecham
carvedilol phosphate
CAPSULE, EXTENDED RELEASE;ORAL022012-001Oct 20, 2006RXNo8,101,209*PEDMar 11, 2026Y
Smithkline Beecham
carvedilol phosphate
CAPSULE, EXTENDED RELEASE;ORAL022012-002Oct 20, 2006RXNo8,101,209*PEDMar 11, 2026Y
Smithkline Beecham
carvedilol phosphate
CAPSULE, EXTENDED RELEASE;ORAL022012-003Oct 20, 2006RXYes8,101,209*PEDMar 11, 2026Y
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Foreign Priority and PCT Information for Patent: 8,101,209

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
France01 12999Oct 09, 2001

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