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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Fish and Richardson
US Department of Justice
Farmers Insurance

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,101,209

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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. 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;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Smithkline BeechamCOREG CRcarvedilol phosphateCAPSULE, EXTENDED RELEASE;ORAL022012-001Oct 20, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeY
Smithkline BeechamCOREG CRcarvedilol phosphateCAPSULE, EXTENDED RELEASE;ORAL022012-002Oct 20, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeY
Smithkline BeechamCOREG CRcarvedilol phosphateCAPSULE, EXTENDED RELEASE;ORAL022012-003Oct 20, 2006ABRXYesYes► Subscribe► Subscribe► SubscribeY
Smithkline BeechamCOREG CRcarvedilol phosphateCAPSULE, EXTENDED RELEASE;ORAL022012-004Oct 20, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeY
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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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Serving leading biopharmaceutical companies globally:

US Army
US Department of Justice
Boehringer Ingelheim
Daiichi Sankyo
Harvard Business School
Farmers Insurance

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