small molecule

DYANAVEL XR

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

Loss of exclusivitySeptember 2036latest FDA-listed patent expiry
CompanyTris.View the full company profile on CliffBio

Drug detail

Brand nameDYANAVEL XR
Active ingredientAMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Strength2MG/ML;EQ 0.5MG BASE/ML
Dosage formSUSPENSION, EXTENDED RELEASE
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2015
Marketing statusRX

Listed patents

PatentExpiresType
11590228September 2036product
8062667March 2029product
8597684March 2027product
10086087March 2027product
8747902March 2027product
8883217March 2027product
9675703March 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 patent cliff — loss of exclusivity September 2036 | CliffBio