Nitisinone

Overview

Nitisinone is an inhibitor of the enzyme 4-Hydroxyphenylpyruvate dioxygenase used in the treatment of hereditary tyrosinemia type 1 (HT-1), a genetic disorder that can cause liver and kidney damage. It prevents the accumulation of toxic byproducts of tyrosine metabolism by blocking its catabolic pathway.

API suppliers (6)

Suppliers of Nitisinone backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

• FARMAK AS1 active DMF
• NOVITIUM PHARMA LLCUnited States1 active DMF
• FARMAK AS1 active DMF
• FARMAK AS1 active DMF
• MEDEA RESEARCH LABORATORIES INC
• ASPEN OSS BV

Patent & exclusivity (US)

Per the FDA Orange Book (20 approved US products), the latest listed US patent on Nitisinone expires 5 Jan 2035 and exclusivity 9 Jun 2032. Generic API sourcing typically opens up once these lapse.

Therapeutic areas