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Last Updated: May 19, 2024

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

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 Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-001 Nov 26, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 Healthcare VITRAKVI larotrectinib sulfate SOLUTION;ORAL 211710-001 Nov 26, 2018 RX Yes Yes ⤷  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

Supplementary Protection Certificates for larotrectinib sulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3106463 CR 2020 00013 Denmark ⤷  Try a Trial PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
3106463 2020004 Norway ⤷  Try a Trial PRODUCT NAME: LAROTREKTINIB OG/ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV, SAERLIG LAROTREKTINIBSULFAT INKLUDERT LAROTREKTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20191018
3106463 2020C/507 Belgium ⤷  Try a Trial PRODUCT NAME: VITRAKVI - LAROTRECTINIB ET/OU SES SELS ACCEPTABLES EN PHARMACIE, EN PARTICULIER L'HYDROGENO SULFATE 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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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.