small molecule

HEPZATO

MELPHALAN HYDROCHLORIDE

Loss of exclusivitySeptember 2034latest FDA-listed patent expiry

CompanyDelcath Systems →View the full company profile on CliffBio

Drug detail

Brand name	HEPZATO
Active ingredient	MELPHALAN HYDROCHLORIDE
Strength	EQ 50MG BASE/VIAL
Dosage form	POWDER
Route	INTRA-ARTERIAL
Modality	Small molecule
FDA approval	August 2023
Marketing status	RX

Listed patents

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

Regulatory exclusivity

Code	Expires
ODE-438	August 2030
NP	August 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.