drug
cysteamine DR
Marketedupdated 5mo agoby Horizon Therapeutics USA Inc
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 3 investigational indications.
indications
investigational
Cystic Fibrosis
all catalysts(0)
nothing on the calendar yet
Trials studying cysteamine DR
- phase2PK and PD Study of NPI-001 and Cysteamine Bitartrate
- phase2A Dose-ranging Study of TTI-0102 in Adults and Children With Leigh Syndrome Spectrum (LSS)
- phase2A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease
- phase2Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease
- phase3Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
- phase3Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 26, 2027
115 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (96)
- Feb 16, 2037patentUS 10143665*PED
- Feb 16, 2037patentUS 10143665*PED
- Feb 16, 2037patentUS 10143665*PED
- Feb 16, 2037patentUS 10143665*PED
- Feb 16, 2037patentUS 10328037*PED
- Feb 16, 2037patentUS 10328037*PED
- Feb 16, 2037patentUS 10328037*PED
- Feb 16, 2037patentUS 10328037*PED
- Feb 16, 2037patentUS 10548859*PED
- Feb 16, 2037patentUS 10548859*PED
- Feb 16, 2037patentUS 10548859*PED
- Feb 16, 2037patentUS 10548859*PED
- Feb 16, 2037patentUS 10905662*PED
- Feb 16, 2037patentUS 10905662*PED
- Feb 16, 2037patentUS 10905662*PED
- Feb 16, 2037patentUS 10905662*PED
- Aug 16, 2036method-of-use (U-1399)US 10143665
- Aug 16, 2036method-of-use (U-1399)US 10143665
- Aug 16, 2036method-of-use (U-1399)US 10143665
- Aug 16, 2036method-of-use (U-1399)US 10143665
- Aug 16, 2036method-of-use (U-1399)US 10328037
- Aug 16, 2036method-of-use (U-1399)US 10328037
- Aug 16, 2036method-of-use (U-1399)US 10328037
- Aug 16, 2036method-of-use (U-1399)US 10328037
- Aug 16, 2036method-of-use (U-1399)US 10548859
- Aug 16, 2036method-of-use (U-1399)US 10548859
- Aug 16, 2036method-of-use (U-1399)US 10548859
- Aug 16, 2036method-of-use (U-1399)US 10548859
- Aug 16, 2036method-of-use (U-1399)US 10905662
- Aug 16, 2036method-of-use (U-1399)US 10905662
- Aug 16, 2036method-of-use (U-1399)US 10905662
- Aug 16, 2036method-of-use (U-1399)US 10905662
- Dec 17, 2034patentUS 9173851*PED
- Dec 17, 2034patentUS 9173851*PED
- Dec 17, 2034patentUS 9173851*PED
- Dec 17, 2034patentUS 9173851*PED
- Dec 17, 2034patentUS 9233077*PED
- Dec 17, 2034patentUS 9233077*PED
- Dec 17, 2034patentUS 9233077*PED
- Dec 17, 2034patentUS 9233077*PED
- Jun 17, 2034formulationUS 9173851
- Jun 17, 2034formulationUS 9173851
- Jun 17, 2034formulationUS 9173851
- Jun 17, 2034formulationUS 9173851
- Jun 17, 2034formulationUS 9233077
- Jun 17, 2034formulationUS 9233077
- Jun 17, 2034formulationUS 9233077
- Jun 17, 2034formulationUS 9233077
- Mar 22, 2028patentUS 8026284*PED1.5y
- Mar 22, 2028patentUS 8026284*PED1.5y
- Mar 22, 2028patentUS 8026284*PED1.5y
- Mar 22, 2028patentUS 8026284*PED1.5y
- Sep 22, 2027method-of-use (U-1399)US 8026284354d
- Sep 22, 2027method-of-use (U-1399)US 8026284354d
- Sep 22, 2027method-of-use (U-1399)US 8026284354d
- Sep 22, 2027method-of-use (U-1399)US 8026284354d
- Jul 26, 2027patentUS 9192590*PED296d
- Jul 26, 2027patentUS 9192590*PED296d
- Jul 26, 2027patentUS 9192590*PED296d
- Jul 26, 2027patentUS 9192590*PED296d
- Jul 26, 2027patentUS 9198882*PED296d
- Jul 26, 2027patentUS 9198882*PED296d
- Jul 26, 2027patentUS 9198882*PED296d
- Jul 26, 2027patentUS 9198882*PED296d
- Jul 26, 2027patentUS 9925156*PED296d
- Jul 26, 2027patentUS 9925156*PED296d
- Jul 26, 2027patentUS 9925156*PED296d
- Jul 26, 2027patentUS 9925156*PED296d
- Jul 26, 2027patentUS 9925157*PED296d
- Jul 26, 2027patentUS 9925157*PED296d
- Jul 26, 2027patentUS 9925157*PED296d
- Jul 26, 2027patentUS 9925157*PED296d
- Jul 26, 2027patentUS 9925158*PED296d
- Jul 26, 2027patentUS 9925158*PED296d
- Jul 26, 2027patentUS 9925158*PED296d
- Jul 26, 2027patentUS 9925158*PED296d
- Jan 26, 2027method-of-use (U-1399)US 9192590115d
- Jan 26, 2027method-of-use (U-1399)US 9192590115d
- Jan 26, 2027method-of-use (U-1399)US 9192590115d
- Jan 26, 2027method-of-use (U-1399)US 9192590115d
- Jan 26, 2027method-of-use (U-1399)US 9198882115d
- Jan 26, 2027method-of-use (U-1399)US 9198882115d
- Jan 26, 2027method-of-use (U-1399)US 9198882115d
- Jan 26, 2027method-of-use (U-1399)US 9198882115d
- Jan 26, 2027formulationUS 9925156115d
- Jan 26, 2027formulationUS 9925156115d
- Jan 26, 2027compositionUS 9925156115d
- Jan 26, 2027compositionUS 9925156115d
- Jan 26, 2027compositionUS 9925157115d
- Jan 26, 2027formulationUS 9925157115d
- Jan 26, 2027compositionUS 9925157115d
- Jan 26, 2027formulationUS 9925157115d
- Jan 26, 2027compositionUS 9925158115d
- Jan 26, 2027formulationUS 9925158115d
- Jan 26, 2027formulationUS 9925158115d
- Jan 26, 2027compositionUS 9925158115d
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