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Patent RE42096 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.
This patent has ten patent family members in eight countries.
Summary for Patent: RE42096
|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 of 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 (Downingtow, PA), Couch; Richard A. (Bryn Mawr, PA), Chang; Rong-Kun (Rockville, MD), Treacy; Donald J. (Woodbine, MD), McGuiness; Charlotte M. (Bethesda, MD), Rudnic; Edward M. (North Potomac, MD)|
|Assignee:||Shire LLC, USA (N/A)|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for patent RE42096|
Patent Claim Types:|
see list of patent claims
|Country||Patent Number||Estimated Expiration||Supplementary Protection Certificate||SPC Country||SPC Expiration|
|European Patent Office||1123087||Start Trial|
|European Patent Office||1977736||Start Trial|
|>Country||>Patent Number||>Estimated Expiration||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration|