NDAORALPOWDER
Approved
Dec 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
BH4, the cofactor for the enzyme phenylalanine hydroxylase (PAH). PAH hydroxylates Phe through an oxidative reaction to form tyrosine. In patients with PKU, PAH activity is absent or deficient. Treatment with BH4 can activate residual PAH enzyme activity, improve the normal oxidative metabolism of…
Clinical Trials (5)
The Effectiveness of Kuvan in Amish PKU Patients
Started Jan 2018
7 enrolled
Phenylketonuria
Retrospective Observational Safety Effectiveness With Kuvan in hpA
Started Oct 2017
26 enrolled
Tetrahydrobiopterin Deficiency
Kuvan®'s Effect on the Cognition of Children With Phenylketonuria
Started Oct 2013
34 enrolled
Phenylketonuria
Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria
Started Nov 2012
Phenylketonuria
The Effects of Sapropterin Dihydrochloride Supplementation on in Vivo Redox Status in Patients With Classical PKU
Started Jul 2012
0Classical Phenylketonuria(PKU)
Loss of Exclusivity
LOE Date
May 1, 2033
87 months away
Patent Expiry
May 1, 2033
Patent Records (2)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9216178 | Nov 1, 2032 | Product | — |
| 9216178*PED | May 1, 2033 | — |