CliffBio
small molecule

HEPZATO

MELPHALAN HYDROCHLORIDE

Loss of exclusivitySeptember 2034latest FDA-listed patent expiry
CompanyDelcath Systems →See this company's full patent-cliff portfolio

Drug detail

Brand nameHEPZATO
Active ingredientMELPHALAN HYDROCHLORIDE
StrengthEQ 50MG BASE/VIAL
Dosage formPOWDER
RouteINTRA-ARTERIAL
ModalitySmall molecule
FDA approvalAugust 2023
Marketing statusRX

Listed patents

PatentExpiresType
9707331September 2034product
9314561February 2034product
10195334January 2033product
11083831December 2032product
11833286December 2032product
11633528November 2032use U-3675
10098997November 2032product
11241522November 2032product
10369264November 2032product
10569004November 2032use U-3683

Regulatory exclusivity

CodeExpires
ODE-438August 2030
NPAugust 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.