small molecule

DYANAVEL XR 10

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Loss of exclusivityFebruary 2040latest FDA-listed patent expiry
CompanyTris.View the full company profile on CliffBio

Drug detail

Brand nameDYANAVEL XR 10
Active ingredientAMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Strength8MG;EQ 2MG BASE
Dosage formTABLET, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2021
Marketing statusRX

Listed patents

PatentExpiresType
12458592February 2040use U-3538
11590081September 2038product
8337890March 2027product
8747902March 2027product
9675704March 2027product

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

DYANAVEL XR 10 patent cliff — loss of exclusivity February 2040 | CliffBio