small molecule

DAWNZERA (AUTOINJECTOR)

DONIDALORSEN SODIUM

Loss of exclusivityMay 2035latest FDA-listed patent expiry
CompanyIonis PharmaceuticalsSee this company's full patent-cliff portfolio

Drug detail

Brand nameDAWNZERA (AUTOINJECTOR)
Active ingredientDONIDALORSEN SODIUM
StrengthEQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
Dosage formSOLUTION
RouteSUBCUTANEOUS
ModalitySmall molecule
FDA approvalAugust 2025
Marketing statusRX

Listed patents

PatentExpiresType
10294477May 2035substance, product
9670492August 2034substance
9127276May 2034substance
9181549May 2034substance
9315811October 2032use U-3010

Regulatory exclusivity

CodeExpires
ODE-550August 2032

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.

DAWNZERA (AUTOINJECTOR) patent cliff — loss of exclusivity May 2035 | CliffBio