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Details for Patent: 6,344,215

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Patent 6,344,215 protects METADATE CD and is included in one NDA. There have been two Paragraph IV challenges on Metadate CD. There are three tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has thirteen patent family members in eight 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;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 8th percentile
Forward Citations: 3rd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Ucb Inc
METADATE CD
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021259-003May 27, 2003RXNo6,344,215► subscribeY
Ucb Inc
METADATE CD
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021259-001Apr 3, 2001RXNo6,344,215► subscribeY
Ucb Inc
METADATE CD
methylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021259-002Jun 19, 2003RXNo6,344,215► subscribeY
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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
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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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