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Details for Patent: RE41148

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Patent RE41148 protects ADDERALL XR 10, ADDERALL XR 15, ADDERALL XR 20, ADDERALL XR 25, ADDERALL XR 30, and ADDERALL XR 5, and is included in one NDA.

Protection for ADDERALL XR 10 has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: RE41148

Title:Oral pulsed dose drug delivery system
Abstract:A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.
Inventor(s): Burnside; Beth A. (Bethesda, MD), Guo; Xiaodi (Apex, NC), Fiske; Kimberly (Downingtown, PA), Couch; Richard A. (Bryn Mawr, PA), Treacy; Donald J. (Woodbine, MD), Chang; Rong-Kun (Rockville, MD), Rudnic; Edward M. (North Potomac, MD), McGuinness; Charlotte M. (Bethesda, MD)
Assignee: Shire Laboratories, Inc. (Rockville, MD)
Application Number:11/091,010
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Delivery;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-001Oct 11, 2001RXYesNoRE41148*PED► subscribe
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-006May 22, 2002RXYesNoRE41148*PED► subscribe
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-002Oct 11, 2001RXYesNoRE41148*PED► subscribe
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Foreign Priority and PCT Information for Patent: RE41148

PCT Information
PCT FiledOctober 20, 1999PCT Application Number:PCT/US99/24554
PCT Publication Date:April 27, 2000PCT Publication Number: WO00/23055

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