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 twelve patent family members in fifty countries.
Two suppliers are listed for this compound.
Summary for LAROTRECTINIB SULFATE
International Patents: | 212 |
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 | 210861-001 | Nov 26, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bayer Healthcare | VITRAKVI | larotrectinib sulfate | SOLUTION;ORAL | 211710-001 | Nov 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bayer Hlthcare | VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861-002 | Nov 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bayer Healthcare | VITRAKVI | larotrectinib sulfate | SOLUTION;ORAL | 211710-001 | Nov 26, 2018 | RX | Yes | Yes | ⤷ 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 |
International Patents for LAROTRECTINIB SULFATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2009308465 | Substituted pyrazolo[1,5-a]pyrimidine compounds as TRK kinase inhibitors | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2017176744 | ⤷ Sign Up | |
European Patent Office | 3218380 | FORME CRISTALLINE D'HYDROGÉNOSULFATE DE (S)-N-(5-((R)-2-(2,5-DIFLUOROPHÉNYL)-PYRROLIDIN-1-YL)-PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE (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) | ⤷ Sign Up |
Spain | 2669581 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LAROTRECTINIB SULFATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3106463 | CA 2020 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923 |
3106463 | PA2020504 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LAROTREKTINIBAS IR (ARBA) FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC LAROTREKTINIBO SULFATAS, ISKAITANT LAROTREKTINIBO VANDENILIO SULFATA; REGISTRATION NO/DATE: EU/1/19/1385 20190919 |
3106463 | 2090009-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: LAROTRECTINIB,OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REG. NO/DATE: EU/1/19/1385 20190923 |
3106463 | PA2020504,C3106463 | Lithuania | ⤷ Sign Up | 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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