NDAORALCAPSULE, DELAYED RELEASE
Approved
Apr 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Clinical Trials (5)
A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease
Started May 2015
22 enrolled
Mitochondrial Diseases
Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-Release Capsules (RP103) in Cystinosis
Started Jan 2013
41 enrolled
Cystinosis
Safety/Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naive Patients With Cystinosis
Started Dec 2012
17 enrolled
Cystinosis
Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
Started Aug 2010
60 enrolled
Cystinosis
Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis
Started Jun 2010
43 enrolled
Cystinosis
Loss of Exclusivity
LOE Date
Feb 16, 2037
133 months away
Patent Expiry
Feb 16, 2037