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-six patent family members in twenty countries.
Two suppliers are listed for this compound.
Summary for LUMATEPERONE TOSYLATE
International Patents: | 146 |
US Patents: | 18 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
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
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 |
---|---|---|---|
European Patent Office | 3076967 | NOUVEAUX PROCÉDÉS (NOVEL METHODS) | ⤷ Sign Up |
Japan | 2019147819 | 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) | ⤷ Sign Up |
Japan | 6874028 | ⤷ Sign Up | |
South Korea | 20230023817 | 신규한 방법 (NOVEL METHODS) | ⤷ Sign Up |
China | 114366741 | 新方法 (Novel method) | ⤷ Sign Up |
South Korea | 20200047755 | 치환된 헤테로환 융합 감마-카르볼린 합성 (- SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SYNTHESIS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2008112280 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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