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Serving leading biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,344,215

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Which drugs does patent 6,344,215 protect, and when does it expire?

Patent 6,344,215 protects METADATE CD and is included in one NDA. There have been two Paragraph IV challenges on Metadate CD.

This patent has fourteen patent family members in eleven countries.

Summary for Patent: 6,344,215

Title: Methylphenidate modified release formulations
Abstract:A pharmaceutical MR (modified release) multiparticulate dosage form such as a capsule (once-a-day MR Capsule) of Methylphenidate indicated for the treatment of children with attention deficit hyperactivity disorder (ADHD), capable of delivering a portion of the dose for rapid onset of action and the remainder of the dose in a controlled manner for about 12 hours, is composed of a multitude of multicoated particles made of two populations of drug layered beads, IR (immediate release) and ER (extended release) Beads. The IR beads preferably are made by layering an aqueous solution comprising a drug and a binder on to non-pareil sugar spheres and then applying a seal coat to the drug coated cores. The ER Beads are made by applying an extended release coating of a water insoluble dissolution rate controlling polymer such as ethylcellulose to IR Beads. The MR Capsules are manufactured by filling IR and ER Beads in a proper ratio; the dose and the ratio required for an efficacious, cost effective and patient compliant treatment of children with ADHD were determined from extensive clinical investigations and in vitro- in vivo correlations performed as per FDA Guidelines, Guidance for Industry: Extended Release Oral Dosage Forms.
Inventor(s): Bettman; Marie J. (Clayton, OH), Percel; Phillip J. (Troy, OH), Hensley; Dan L. (Huber Heights, OH), Vishnupad; Krishna S. (Dayton, OH), Venkatesh; Gopi M. (Dayton, OH)
Assignee: Eurand America, Inc. (Vandalia, OH)
Application Number:09/697,803
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Device;

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
Ucb IncMETADATE CDmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021259-003May 27, 2003AB2RXYesNo► Subscribe► SubscribeY► Subscribe
Ucb IncMETADATE CDmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021259-001Apr 3, 2001AB2RXYesNo► Subscribe► SubscribeY► Subscribe
Ucb IncMETADATE CDmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021259-002Jun 19, 2003AB2RXYesNo► Subscribe► SubscribeY► Subscribe
Ucb IncMETADATE CDmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021259-004Feb 19, 2006AB2RXYesNo► Subscribe► SubscribeY► Subscribe
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International Patent Family for Patent: 6,344,215

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2001297011► Subscribe
Australia9701101► Subscribe
Canada2426883► Subscribe
Denmark2103307► Subscribe
European Patent Office1328251► Subscribe
European Patent Office2103307► Subscribe
European Patent Office2269605► Subscribe
European Patent Office2286815► Subscribe
Spain2618603► Subscribe
Hungary0303695► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
Argus Health
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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