NDAORALSUSPENSION
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Mechanism of Action
Hydroxyphenylpyruvate Dioxygenase Inhibitors
Pharmacologic Class:
4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Clinical Trials (5)
A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients
Started Sep 2025
A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers
Started Mar 2017
Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1
Started Dec 2014
Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care
Started Sep 2013
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
Started May 2013
Loss of Exclusivity
LOE Date
Feb 28, 2033
85 months away
Patent Expiry
Feb 28, 2033
Patent Records (1)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9301932 | Feb 28, 2033 | Product | U-1836 |