CliffBio
small molecule

SKYCLARYS

OMAVELOXOLONE

Loss of exclusivityApril 2033latest FDA-listed patent expiry
CompanyBIOGEN US CORPORATION

Drug detail

Brand nameSKYCLARYS
Active ingredientOMAVELOXOLONE
Strength50MG
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2023
Marketing statusRX

Listed patents

PatentExpiresType
9701709April 2033substance, product
8993640April 2033substance, product
8124799December 2029substance
8440854April 2029product
9670147April 2029substance
11919838April 2029use U-3863
11091430April 2029use U-3552

Regulatory exclusivity

CodeExpires
ODE-427February 2030
NCEFebruary 2028
M-270December 2027

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.

SKYCLARYS patent cliff — loss of exclusivity April 2033 | CliffBio