drug · small molecule
lumateperone tosylate
Marketedupdated 5mo agoby Intra-Cellular Therapies Inc🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for schizophrenia and 1 investigational indication.
indications
investigational
SchizophreniaMajor Depression
all catalysts(7)
approval · 7
Dec 20, 2019
approval
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Dec 20, 2019
approval
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Dec 17, 2021
approval
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Dec 17, 2021
approval
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Apr 26, 2022
approval
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Jun 28, 2023
approval
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Nov 5, 2025
approval
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Trials studying lumateperone tosylate
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 12, 2028
~1.4 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (56)
- Dec 10, 2040formulationUS 12122792
- Dec 10, 2040formulationUS 12122792
- Dec 10, 2040formulationUS 12122792
- Dec 10, 2040formulationUS 12410195
- Dec 10, 2040formulationUS 12410195
- Dec 10, 2040formulationUS 12410195
- Jul 7, 2040formulationUS 12090155
- Oct 27, 2039method-of-use (U-3940)US 11980617
- Oct 27, 2039method-of-use (U-3940)US 11980617
- Oct 27, 2039method-of-use (U-3940)US 11980617
- Aug 30, 2039formulationUS 10695345
- Aug 30, 2039formulationUS 10695345
- Aug 30, 2039formulationUS 10695345
- Aug 30, 2039formulationUS 11052084
- Aug 30, 2039formulationUS 11052084
- Aug 30, 2039formulationUS 11690842
- Aug 30, 2039formulationUS 11690842
- Aug 30, 2039formulationUS 11690842
- Aug 30, 2039formulationUS 11806348
- Aug 30, 2039formulationUS 11806348
- Aug 30, 2039formulationUS 11806348
- Aug 30, 2039formulationUS 12070459
- Aug 30, 2039formulationUS 12128043
- Mar 15, 2039method-of-use (U-4261)US 12409176
- Mar 15, 2039method-of-use (U-4261)US 12409176
- Mar 15, 2039method-of-use (U-4261)US 12409176
- Dec 3, 2034method-of-use (U-814)US 10960009
- Dec 3, 2034method-of-use (U-3364)US 11026951
- Dec 3, 2034method-of-use (U-3364)US 11026951
- Dec 3, 2034method-of-use (U-3274)US 11026951
- Dec 3, 2034method-of-use (U-2714)US 9956227
- Dec 3, 2034method-of-use (U-2714)US 9956227
- Dec 3, 2034method-of-use (U-2714)US 9956227
- Aug 19, 2033method-of-use (U-814)US RE48839
- Aug 19, 2033method-of-use (U-814)US RE48839
- Aug 19, 2033method-of-use (U-3271)US RE48839
- Dec 1, 2029compositionUS 86480773.2y
- Dec 1, 2029compositionUS 86480773.2y
- Dec 1, 2029compositionUS 86480773.2y
- May 27, 2029method-of-use (U-3271)US 101178672.6y
- May 27, 2029method-of-use (U-3271)US 101178672.6y
- May 27, 2029method-of-use (U-3271)US 101178672.6y
- May 27, 2029formulationUS 91682582.6y
- May 27, 2029formulationUS 96160612.6y
- May 27, 2029formulationUS 96160612.6y
- May 27, 2029formulationUS 96160612.6y
- Mar 12, 2029method-of-use (U-2713)US 91999952.4y
- Mar 12, 2029method-of-use (U-4343)US 91999952.4y
- Mar 12, 2029method-of-use (U-2713)US 91999952.4y
- Mar 12, 2029compositionUS 95869602.4y
- Mar 12, 2029compositionUS RE488252.4y
- Mar 12, 2029compositionUS RE488252.4y
- Mar 12, 2029compositionUS RE488252.4y
- Mar 12, 2028formulationUS 104649381.4y
- Mar 12, 2028formulationUS 104649381.4y
- Mar 12, 2028formulationUS 104649381.4y
FDA exclusivities (3)
- Nov 5, 2028I-904Indication (3y)2.1y
- Nov 5, 2028I-904Indication (3y)2.1y
- Nov 5, 2028I-904Indication (3y)2.1y
News(3)
- An orexin drug’s ‘proof-of-concept’ in ADHD; Cue’s ‘unwarranted’ share slideAlkermes’ results heightened anticipation for a coming readout in 2027. Elsewhere, AbbVie leaned into AI drug discovery and the FDA expanded use of Eli Lilly’s breast cancer pill.biopharma_dive · 11d ago
- As BMS’ Cobenfy struggles to gain traction, MapLight knocks on the doorDespite the recent emergence of a new drug class, schizophrenia remains one of the most challenging neuropsychiatric diseases to treat—and Cobenfy's first steps into the market indicate there is st…biospace · 1mo ago
- J&J dips despite upbeat outlook; AstraZeneca, Spero cut China dealsJ&J’s shares ticked down as oncology sales missed expectations. Elsewhere, AstraZeneca bet $600 million on a lung cancer drug and a pair of biotechs snagged two of the year’s top venture rounds.biopharma_dive · 2mo ago
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