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Last Updated: December 3, 2021

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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 seventy-one patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for larotrectinib sulfate
International Patents:171
US Patents:16
Tradenames:1
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 28
Clinical Trials: 4
Patent Applications: 34
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 Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-002 Nov 26, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-001 Nov 26, 2018 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-002 Nov 26, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bayer Hlthcare VITRAKVI larotrectinib sulfate CAPSULE;ORAL 210861-001 Nov 26, 2018 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 LUC00150 Luxembourg ⤷  Try it Free 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
3106463 PA2020504,C3106463 Lithuania ⤷  Try it Free 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 C03106463/01 Switzerland ⤷  Try it Free PRODUCT NAME: LAROTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67282 28.05.2020
3106463 301033 Netherlands ⤷  Try it Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Mallinckrodt
McKinsey
Baxter
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.