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Last Updated: April 1, 2023

Larotrectinib sulfate - Generic Drug Details


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What are the generic drug sources for larotrectinib sulfate and what is the scope of freedom to operate?

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

Larotrectinib sulfate has one hundred and ninety-seven patent family members in forty-nine countries.

Two suppliers are listed for this compound.

Summary for larotrectinib sulfate
International Patents:197
US Patents:16
Tradenames:1
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 4
Patent Applications: 152
DailyMed Link:larotrectinib sulfate at DailyMed
Recent Clinical Trials for larotrectinib sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
M.D. Anderson Cancer CenterPhase 2
Children's Oncology GroupPhase 2
National Cancer Institute (NCI)Phase 2

See all larotrectinib sulfate clinical trials

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 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 210861-001 Nov 26, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-001 Nov 26, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-001 Nov 26, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-001 Nov 26, 2018 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

International Patents for larotrectinib sulfate

Country Patent Number Title Estimated Expiration
Croatia P20211722 ⤷  Sign Up
Spain 2900243 ⤷  Sign Up
Japan 2014177494 SUBSTITUTED PYRAZOLO[1,5-a]PYRIMIDINE COMPOUND AS TRK KINASE INHIBITOR ⤷  Sign Up
Singapore 11201703962X 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
South Korea 20170082628 (S)-N-(5-((R)-2--피라졸로[1,5-A]피리미딘-3-일)-3-히드록시피롤리딘-1-카르복스아미드 히드로겐 술페이트의 결정질 형태 (S-N-5-R-2-25---1--[15-A]-3--3--1- CRYSTALLINE FORM OF S-N-5-R-2-25-DIFLUOROPHENYL-PYRROLIDIN-1-YL-PYRAZOLO[15-A]PYRIMIDIN-3-YL-3-HYDROXYPYRROLIDINE-1-CARBOXAMIDE HYDROGEN SULFATE) ⤷  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 122020000012 Germany ⤷  Sign Up PRODUCT NAME: LAROTRECTINIB ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, EINSCHLIESSLICH LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919
3106463 2020004 Norway ⤷  Sign Up PRODUCT NAME: LAROTREKTINIB OG/ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV, SAERLIG LAROTREKTINIBSULFAT INKLUDERT LAROTREKTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20191018
3106463 132020000000025 Italy ⤷  Sign Up 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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.