Last Updated: November 9, 2026

Details for Patent: 12,458,592

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Summary for Patent: 12,458,592
Title:Extended release amphetamine tablets
Abstract:An oral amphetamine extended release solid dose is described. The compositions contain a combination of an uncoated amphetamine-cation exchange resin complex, a barrier coated amphetamine-cation exchange resin complex-matrix, and an uncomplexed amphetamine, wherein one or more of these components contains blends of different forms of amphetamines. Either the modified release coated and/or the uncoated amphetamine-cation exchange resin complex may have two forms of amphetamine in a complex with a single cation exchange resin. Following administration of a single dose of the composition, a therapeutically effective amount of amphetamine is reached by about one hour and the composition provides at least a thirteen hour effect post-dose.
Inventor(s):Ketan Mehta, Kalyan Kathala, Antonio Pardo
Assignee: Tris Pharma Inc
Application Number:US17/576,114
Patent Claim Types:
see list of patent claims
Use; Dosage form;

Drugs Protected by US Patent 12,458,592

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tris Pharma Inc DYANAVEL XR 10 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-002 Nov 4, 2021 RX Yes No ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER ⤷  Start Trial
Tris Pharma Inc DYANAVEL XR 15 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-003 Nov 4, 2021 RX Yes No ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER ⤷  Start Trial
Tris Pharma Inc DYANAVEL XR 20 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-004 Nov 4, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER ⤷  Start Trial
Tris Pharma Inc DYANAVEL XR 5 amphetamine; amphetamine aspartate/dextroamphetamine sulfate TABLET, EXTENDED RELEASE;ORAL 210526-001 Nov 4, 2021 RX Yes No ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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