Larotrectinib sulfate - Generic Drug Details
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What are the generic sources for larotrectinib sulfate and what is the scope of patent protection?
Larotrectinib sulfate
is the generic ingredient in one branded drug marketed by Bayer Hlthcare and Bayer Healthcare, and is included in two NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Larotrectinib sulfate has two hundred and ten patent family members in fifty countries.
Two suppliers are listed for this compound.
Summary for larotrectinib sulfate
International Patents: | 210 |
US Patents: | 18 |
Tradenames: | 1 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 43 |
Clinical Trials: | 4 |
Patent Applications: | 126 |
DailyMed Link: | larotrectinib sulfate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for larotrectinib sulfate
Generic Entry Dates for larotrectinib sulfate*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for larotrectinib sulfate*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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 larotrectinib sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
M.D. Anderson Cancer Center | Phase 2 |
Children's Oncology Group | Phase 2 |
National Cancer Institute (NCI) | Phase 2 |
Pharmacology for larotrectinib sulfate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Tropomyosin Receptor Kinases Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for larotrectinib sulfate
US Patents and Regulatory Information for larotrectinib sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861-002 | Nov 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861-002 | Nov 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861-001 | Nov 26, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Bayer Healthcare | VITRAKVI | larotrectinib sulfate | SOLUTION;ORAL | 211710-001 | Nov 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861-001 | Nov 26, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 |
International Patents for larotrectinib sulfate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3439663 | MÉTHODES DE TRAITEMENT DE CANCERS PÉDIATRIQUES (METHODS OF TREATING PEDIATRIC CANCERS) | ⤷ Try a Trial |
Hungary | S2000006 | ⤷ Try a Trial | |
Taiwan | 201625636 | Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate | ⤷ Try a Trial |
Chile | 2019002239 | Métodos de tratamiento de cánceres pediátricos. (divisional solicitud 201802807) | ⤷ Try a Trial |
China | 102264736 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for larotrectinib sulfate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3106463 | 11/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: LAROTRECTINIB UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFAT, EINSCHLIESSLICH LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923 |
3106463 | C202030011 | Spain | ⤷ Try a Trial | PRODUCT NAME: LAROTRECTINIB Y/O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, PARTICULARMENTE SULFATO DE LAROTRECTINIB QUE INCLUYE HIDROGENOSULFATO DE LAROTRECTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/19/1385; DATE OF AUTHORISATION: 20190919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1385; DATE OF FIRST AUTHORISATION IN EEA: 20190919 |
3106463 | C03106463/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LAROTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67282 28.05.2020 |
3106463 | 122020000012 | Germany | ⤷ Try a Trial | PRODUCT NAME: LAROTRECTINIB ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, EINSCHLIESSLICH LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919 |
3106463 | PA2020504,C3106463 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LAROTREKTINIBAS IR (ARBA) FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC LAROTREKTINIBO SULFATAS, ISKAITANT LAROTREKTINIBO VANDENILIO SULFATA; REGISTRATION NO/DATE: EU/1/19/1385 20190919 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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