small molecule

CYTALUX

PAFOLACIANINE SODIUM

Loss of exclusivityNovember 2035latest FDA-listed patent expiry
CompanyON TARGET LABORATORIES INC

Drug detail

Brand nameCYTALUX
Active ingredientPAFOLACIANINE SODIUM
StrengthEQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML)
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalNovember 2021
Marketing statusRX

Listed patents

PatentExpiresType
9061057November 2035substance, product
9254341October 2033substance, product
9333270August 2033substance, product
10881747August 2033substance, product
9789208August 2033substance, product
9341629August 2033substance, product

Regulatory exclusivity

CodeExpires
ODE-390November 2028
NCENovember 2026

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.

CYTALUX patent cliff — loss of exclusivity November 2035 | CliffBio