Details for New Drug Application (NDA): 209500
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The generic ingredient in CAPLYTA is lumateperone tosylate. One supplier is listed for this compound. Additional details are available on the lumateperone tosylate profile page.
Summary for 209500
Tradename: | CAPLYTA |
Applicant: | Intra-cellular |
Ingredient: | lumateperone tosylate |
Patents: | 21 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209500
Generic Entry Date for 209500*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 209500
Suppliers and Packaging for NDA: 209500
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500 | NDA | Intra-Cellular Therapies, Inc | 72060-110 | 72060-110-07 | 7 CAPSULE in 1 BOTTLE (72060-110-07) |
CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500 | NDA | Intra-Cellular Therapies, Inc | 72060-110 | 72060-110-40 | 30 CAPSULE in 1 BOTTLE (72060-110-40) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 42MG BASE | ||||
Approval Date: | Dec 20, 2019 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 17, 2024 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I OR II DISORDER (BIPOLAR DEPRESSION) IN ADULTS, AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE | ||||||||
Regulatory Exclusivity Expiration: | Dec 20, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 27, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF BIPOLAR DEPRESSION |
Expired US Patents for NDA 209500
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Intra-cellular | CAPLYTA | lumateperone tosylate | CAPSULE;ORAL | 209500-001 | Dec 20, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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