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  1. pharmadog
  2. ›drugs
  3. ›Caplyta
drug · small molecule
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lumateperone tosylate

Marketedupdated 3mo ago
by Intra-Cellular Therapies Inc🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • drugCAPLYTA28 co-mentions · 7 sources
  • tagApproval28 co-mentions · 7 sources
  • tagSmall Molecule14 co-mentions · 7 sources

Small 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
7y ago
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Dec 20, 2019
approval
7y ago
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Dec 17, 2021
approval
5y ago
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Dec 17, 2021
approval
5y ago
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Apr 26, 2022
approval
4y ago
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Jun 28, 2023
approval
3y ago
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→
Nov 5, 2025
approval
10mo ago
CAPLYTA (LUMATEPERONE TOSYLATE) — FDA approval
lumateperone tosylate
→

Trials studying lumateperone tosylate

  • phase2Caplyta in Borderline Personality Disordercompletedn=60

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 12, 2028
~1.6 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 86480773.3y
  • Dec 1, 2029compositionUS 86480773.3y
  • Dec 1, 2029compositionUS 86480773.3y
  • May 27, 2029method-of-use (U-3271)US 101178672.8y
  • May 27, 2029method-of-use (U-3271)US 101178672.8y
  • May 27, 2029method-of-use (U-3271)US 101178672.8y
  • May 27, 2029formulationUS 91682582.8y
  • May 27, 2029formulationUS 96160612.8y
  • May 27, 2029formulationUS 96160612.8y
  • May 27, 2029formulationUS 96160612.8y
  • Mar 12, 2029method-of-use (U-2713)US 91999952.6y
  • Mar 12, 2029method-of-use (U-4343)US 91999952.6y
  • Mar 12, 2029method-of-use (U-2713)US 91999952.6y
  • Mar 12, 2029compositionUS 95869602.6y
  • Mar 12, 2029compositionUS RE488252.6y
  • Mar 12, 2029compositionUS RE488252.6y
  • Mar 12, 2029compositionUS RE488252.6y
  • Mar 12, 2028formulationUS 104649381.6y
  • Mar 12, 2028formulationUS 104649381.6y
  • Mar 12, 2028formulationUS 104649381.6y

FDA exclusivities (3)

  • Nov 5, 2028I-904Indication (3y)2.2y
  • Nov 5, 2028I-904Indication (3y)2.2y
  • Nov 5, 2028I-904Indication (3y)2.2y

News(2)

  • As BMS’ Cobenfy struggles to gain traction, MapLight knocks on the door
    Despite 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 · 7d ago
  • J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals
    J&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 · 1mo ago
brand
Caplyta
trade names
Caplyta
generic
lumateperone tosylate
indication
Schizophrenia
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 37m ago
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