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Last Updated: October 23, 2020

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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.

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

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:

Merck
Baxter
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Johnson and Johnson
Mallinckrodt
McKesson

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