Opinion ID: 6498353
Heading Depth: 3
Heading Rank: 1

Heading: A methylphenidate aqueous extended release

Text: oral suspension comprising (1) an immediate re- lease methylphenidate component, (2) a sustained release methylphenidate component, and (3) water, said suspension having a pH of about 3.5 to about 5, 2 The claims at issue on remand and in this appeal are claims 6 and 20 of the ’765 patent, claims 4 and 10 of the ’033 patent, and claims 15, 16, and 20 of the ’390 patent. Remand Decision at 185; see also Appellant’s Br. 6. Case: 21-1495 Document: 49 Page: 4 Filed: 07/07/2022 4 TRIS PHARMA, INC. v. ACTAVIS LABORATORIES FL, INC. wherein said suspension provides a single mean average plasma concentration peak and a therapeutically effective plasma profile for about 12 hours for methylphenidate, and wherein the suspension has a pharmacokinetic profile in which the single mean plasma con- centration peak for methylphenidate has an area under the curve (AUC)0∞ of about 114 to about 180 ng-hr/mL, Cmax of about 11 to about 17 ng/mL, Tmax of about 4 to about 5.25 hours, and T1/2 of about 5 to about 7 hours following a single oral administration of said suspension at a dose equivalent to 60 mg racemic methylphenidate HCl in adults.