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-two patent family members in twenty countries.
One supplier is listed for this compound.
Summary for lumateperone tosylate
International Patents: | 162 |
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*:
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
Sponsor | Phase |
---|---|
New York State Psychiatric Institute | Phase 2 |
Intra-Cellular Therapies, Inc. | Phase 2 |
Pharmacology for lumateperone tosylate
Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes 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 | 209500-003 | Apr 22, 2022 | RX | Yes | No | ⤷ 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 | 209500-001 | 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 | ||||
>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 | ⤷ 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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 105939712 | 新方法 (NOVEL METHODS) | ⤷ Sign Up |
Poland | 3076967 | ⤷ Sign Up | |
Australia | 2019229334 | SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SYNTHESIS | ⤷ Sign Up |
China | 105237536 | Substituted heterocycle fused gamma-carbolines solid | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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