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Last Updated: October 23, 2020

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

Larotrectinib sulfate has one hundred and fifty patent family members in forty-two countries.

One supplier is listed for this compound.

Summary for LAROTRECTINIB SULFATE
International Patents:150
US Patents:12
Tradenames:1
Applicants:2
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 23
Patent Applications: 32
DailyMed Link:LAROTRECTINIB SULFATE at DailyMed
Pharmacology 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   Start Trial   Start Trial Y Y   Start Trial
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-002 Nov 26, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-001 Nov 26, 2018 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-002 Nov 26, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-002 Nov 26, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for LAROTRECTINIB SULFATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3106463 132020000000025 Italy   Start Trial PRODUCT NAME: LAROTRECTINIB E/O SUOI SALI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE LAROTRECTINIB SOLFATO INCLUSO LAROTRECTINIB IDROGENO SOLFATO(VITRAKVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1385, 20190923
3106463 2090009-8 Sweden   Start Trial 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 301033 Netherlands   Start Trial PRODUCT NAME: LAROTRECTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LAROTRECTINIBSULFAAT, MET INBEGRIP VAN LAROTRECTINIBSULFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923
3106463 122020000012 Germany   Start Trial PRODUCT NAME: LAROTRECTINIB UND/ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919
3106463 CR 2020 00013 Denmark   Start Trial PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
3106463 CA 2020 00013 Denmark   Start Trial PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
3106463 LUC00150 Luxembourg   Start Trial PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SULFATE DE LAROTRECTINIB, Y COMPRIS L'HYDROGENOSULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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