CliffBio
small molecule

QALSODY

TOFERSEN

Loss of exclusivityApril 2035latest FDA-listed patent expiry
CompanyBIOGEN MA INC

Drug detail

Brand nameQALSODY
Active ingredientTOFERSEN
Strength100MG/15ML (6.7MG/ML)
Dosage formSOLUTION
RouteINTRATHECAL
ModalitySmall molecule
FDA approvalApril 2023
Marketing statusRX

Listed patents

PatentExpiresType
10968453April 2035use U-3575
10669546April 2035use U-3575
10385341April 2035substance, product

Regulatory exclusivity

CodeExpires
ODE-432April 2030
NCEApril 2028

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.

QALSODY patent cliff — loss of exclusivity April 2035 | CliffBio