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CAPLYTA

NDA 209500 · New Drug Application (NDA) Prescription

LUMATEPERONE TOSYLATE

Sponsor (Drugs@FDA)
INTRA-CELLULAR Company: Intra-Cellular Therapies, Inc.
First approved
Latest action

Drugs on HealthTrade

Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.

Products

Drugs@FDA products under NDA 209500, with Orange Book listing details
ProductName and ingredientForm and strengthMarketing statusTE codeReferenceOrange Book
001 CAPLYTA LUMATEPERONE TOSYLATE CAPSULE;ORAL EQ 42MG BASEPrescription– Reference listed drug, Reference standard RXApproved
002 CAPLYTA LUMATEPERONE TOSYLATE CAPSULE;ORAL EQ 10.5MG BASEPrescription– Reference listed drug RXApproved
003 CAPLYTA LUMATEPERONE TOSYLATE CAPSULE;ORAL EQ 21MG BASEPrescription– Reference listed drug RXApproved

Submissions

FDA submissions for NDA 209500, newest first
SubmissionStatusStatus dateReviewClassDocuments
Supplement 17ApprovedstandardEfficacyLetter for Supplement 17 (opens in a new tab)Label for Supplement 17 (opens in a new tab)
Supplement 16ApprovedstandardEfficacyLetter for Supplement 16 (opens in a new tab)Label for Supplement 16 (opens in a new tab)
Supplement 11ApprovedstandardLabelingLetter for Supplement 11 (opens in a new tab)Label for Supplement 11 (opens in a new tab)
Supplement 9ApprovedstandardManufacturing (CMC)Label for Supplement 9 (opens in a new tab)
Supplement 5ApprovedstandardEfficacyLetter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab)
Supplement 6ApprovedstandardEfficacyLetter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab)
Supplement 1ApprovedstandardType 1 - New Molecular EntityLetter for Supplement 1 (opens in a new tab)Label for Supplement 1 (opens in a new tab)
Original 1ApprovedstandardType 1 - New Molecular EntityLetter for Original 1 (opens in a new tab)

Orange Book patents

97 patents listed, as the Orange Book prints them.

Orange Book patents for NDA 209500
PatentExpiresClaimsUse codeSubmitted
10464938Product 001 Drug product –
9199995Product 001 Method of use U-2713
9199995Product 001 Method of use U-4343
9586960Product 001 Drug substance, Drug product –
RE48825Product 001 Drug substance, Drug product –
9616061Product 001 Drug product –
10117867Product 001 Method of use U-3271
8648077Product 001 Drug substance, Drug product –
8598119Product 001 Method of use Delisting requestedU-543
RE48839Product 001 Method of use U-3271
RE48839Product 001 Method of use U-4344
RE48839Product 001 Method of use U-814
9956227Product 001 Method of use U-2714
10960009Product 001 Method of use U-814
11026951Product 001 Method of use U-3274
12409176Product 001 Method of use U-4261
11690842Product 001 Drug product U-3362
11690842Product 001 Drug product U-3363
11690842Product 001 Drug product U-4341
11806348Product 001 Drug product U-3362
11806348Product 001 Drug product U-3363
11806348Product 001 Drug product U-4341
10695345Product 001 Drug product U-543
12128043Product 001 Drug product U-3362
12128043Product 001 Drug product U-3363
12070459Product 001 Drug product U-3362
12070459Product 001 Drug product U-3363
12070459Product 001 Drug product U-4341
11980617Product 001 Method of use U-3940
11980617Product 001 Method of use U-4342
12090155Product 001 Drug product U-4000
12122792Product 001 Drug product U-4019
12122792Product 001 Drug product U-4020
12122792Product 001 Drug product U-4340
11753419Product 001 Drug product Delisting requested–
12410195Product 001 Drug product –
10464938Product 002 Drug product –
9199995Product 002 Method of use U-2713
9199995Product 002 Method of use U-4343
RE48825Product 002 Drug substance –
9616061Product 002 Drug product –
10117867Product 002 Method of use U-3271
9168258Product 002 Drug product –
8648077Product 002 Drug substance, Drug product –
RE48839Product 002 Method of use U-3271
RE48839Product 002 Method of use U-4344
RE48839Product 002 Method of use U-814
9956227Product 002 Method of use U-2714
11026951Product 002 Method of use U-3364
12409176Product 002 Method of use U-4261
10695345Product 002 Drug product U-814
11806348Product 002 Drug product U-3362
11806348Product 002 Drug product U-3363
11806348Product 002 Drug product U-4341
11052084Product 002 Drug product U-3362
11052084Product 002 Drug product U-3363
11052084Product 002 Drug product U-4341
11690842Product 002 Drug product U-3362
11690842Product 002 Drug product U-3363
11690842Product 002 Drug product U-4341
11980617Product 002 Method of use U-3940
11980617Product 002 Method of use U-4342
12122792Product 002 Drug product U-4019
12122792Product 002 Drug product U-4020
12122792Product 002 Drug product U-4340
12410195Product 002 Drug product –
11753419Product 002 Drug product Delisting requested–
10464938Product 003 Drug product –
9199995Product 003 Method of use U-2713
9199995Product 003 Method of use U-4343
RE48825Product 003 Drug substance –
9616061Product 003 Drug product –
10117867Product 003 Method of use U-3271
8648077Product 003 Drug substance, Drug product –
RE48839Product 003 Method of use U-3271
RE48839Product 003 Method of use U-4344
RE48839Product 003 Method of use U-814
9956227Product 003 Method of use U-2714
11026951Product 003 Method of use U-3364
12409176Product 003 Method of use U-4261
10695345Product 003 Drug product U-814
11806348Product 003 Drug product U-3362
11806348Product 003 Drug product U-3363
11806348Product 003 Drug product U-4341
11052084Product 003 Drug product U-3362
11052084Product 003 Drug product U-3363
11052084Product 003 Drug product U-4341
11690842Product 003 Drug product U-3362
11690842Product 003 Drug product U-3363
11690842Product 003 Drug product U-4341
11980617Product 003 Method of use U-3940
11980617Product 003 Method of use U-4342
12122792Product 003 Drug product U-4019
12122792Product 003 Drug product U-4020
12122792Product 003 Drug product U-4340
12410195Product 003 Drug product –
11753419Product 003 Drug product Delisting requested–

Orange Book exclusivities

Orange Book exclusivities for NDA 209500
CodeProductExpires
I-904001
M-319001
I-904002
M-319002
I-904003
M-319003

Codes as the Orange Book prints them; its preface explains each code.

Prescription labels

The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.

  • CAPLYTA Boxed warning

    LUMATEPERONE · Intra-Cellular Therapies, Inc · ORAL · Version 27 · effective

    Boxed warning

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2) ]. The safety and effectiveness of CAPLYTA have not been established in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ; and SUICIDAL THOUGHTS AND BEHAV…

    Indications and usage

    1 INDICATIONS AND USAGE CAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2) ] . Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ]. CAPLYTA is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 ) Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. ( 1 ) Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults. ( 1 )

    Full label on DailyMed for CAPLYTA (opens in a new tab)

NDC products

3 products in the NDC directory with this application number.

NDC directory products for NDA 209500
Product NDCNameLabelerForm and routeCategoryMarketing dates
72060-110 in openFDA (opens in a new tab) CAPLYTA lumateperoneIntra-Cellular Therapies, Inc CAPSULE ORALNDA From
72060-121 in openFDA (opens in a new tab) CAPLYTA lumateperoneIntra-Cellular Therapies, Inc CAPSULE ORALNDA From
72060-142 in openFDA (opens in a new tab) CAPLYTA lumateperoneIntra-Cellular Therapies, Inc CAPSULE ORALNDA From

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Sources

Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”

Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.