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 twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lumateperone tosylate has one hundred and sixty-four patent family members in twenty countries.

One supplier is listed for this compound.

Summary for LUMATEPERONE TOSYLATE

International Patents:	164
US Patents:	21
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	1
Patent Applications:	46
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUMATEPERONE TOSYLATE
DailyMed Link:	LUMATEPERONE TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LUMATEPERONE TOSYLATE

Generic Entry Date for LUMATEPERONE TOSYLATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
New York State Psychiatric Institute	Phase 2
Intra-Cellular Therapies, Inc.	Phase 2

See all LUMATEPERONE TOSYLATE clinical trials

Pharmacology for LUMATEPERONE TOSYLATE

Drug Class	Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for LUMATEPERONE TOSYLATE

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

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Glossary

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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	209500-002	Apr 22, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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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

International Patents for LUMATEPERONE TOSYLATE

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Country	Patent Number	Title	Estimated Expiration
Canada	3108558		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2021119334		⤷ Sign Up
South Korea	20150140418	치환된 헤테로사이클 융합 감마-카볼라인 고체 (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SOLID)	⤷ Sign Up
South Korea	20210038731	치환된 헤테로환 융합 감마-카르볼린 합성 (- SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SYNTHESIS)	⤷ Sign Up
Australia	2021290277	NOVEL METHODS	⤷ Sign Up
Mexico	2022000143	METODOS NOVEDOSOS. (NOVEL METHODS.)	⤷ Sign Up
European Patent Office	2320731	PROCÉDÉS ET COMPOSITIONS POUR LES TROUBLES DU SOMMEIL ET D AUTRES TROUBLES (METHODS AND COMPOSITIONS FOR SLEEP DISORDERS AND OTHER DISORDERS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.