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Last Updated: March 3, 2024

Lumateperone tosylate - Generic Drug Details


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What are the generic sources for lumateperone tosylate and what is the scope of patent protection?

Lumateperone tosylate is the generic ingredient in one branded drug marketed by Intra-cellular and is included in one NDA. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lumateperone tosylate has one hundred and forty-five patent family members in twenty countries.

Two suppliers are listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lumateperone tosylate
Generic Entry Date for lumateperone tosylate*:
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.

Recent Clinical Trials for lumateperone tosylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
New York State Psychiatric InstitutePhase 2
Intra-Cellular Therapies, Inc.Phase 2

See all lumateperone tosylate clinical trials

Pharmacology for lumateperone tosylate
Paragraph IV (Patent) Challenges for LUMATEPERONE TOSYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CAPLYTA Capsules lumateperone tosylate 42 mg 209500 7 2023-12-20

US Patents and Regulatory Information for lumateperone tosylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-002 Apr 22, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-003 Apr 22, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lumateperone tosylate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 ⤷  Try a Trial ⤷  Try a Trial
Intra-cellular CAPLYTA lumateperone tosylate CAPSULE;ORAL 209500-001 Dec 20, 2019 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lumateperone tosylate

Country Patent Number Title Estimated Expiration
Israel 305990 תרכובות הטרוציקליות גאמא-קרבולין דחוסות מותמרות לשימוש בטיפול באי סדרים דו-קוטביים מסוג i ו/או סוג ii (Substituted heterocycle fused gamma-carboline compounds for use in the treatment of bipolar disorder i and/or bipolar ii disorder) ⤷  Try a Trial
South Korea 20220103822 신규한 방법 (NOVEL METHODS) ⤷  Try a Trial
China 102105059 Methods and compositions for sleep disorders and other disorders ⤷  Try a Trial
Japan 2018035189 置換ヘテロ環縮合ガンマ−カルボリンの合成 (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SYNTHESIS) ⤷  Try a Trial
Mexico 347257 SOLIDO DE GAMMA-CARBOLINAS FUSIONADAS CON HETEROCICLOS SUBSTITUIDOS. (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SOLID.) ⤷  Try a Trial
Israel 246002 תרכובות מותמרות של גאמא-קרבולין מאוחה עם הטרוציקלים לשימוש בטיפול בתסמינים שאריתיים של פסיכוזה ותכשיר להזרקה בעל פעילות ארוכת טווח המכיל תרכובות אלו במטריצה (Substituted heterocycle fused gamma-carboline compounds for use in the treatment of residual symptoms of psychosis and a long acting injectable composition comprising such compounds in a matrix) ⤷  Try a Trial
Japan 7261942 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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