Last Updated: November 8, 2026

LAROTRECTINIB SULFATE - Generic Drug Details

Name: LAROTRECTINIB SULFATE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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

Two suppliers are listed for this compound.

Summary for LAROTRECTINIB SULFATE

International Patents:	291
US Patents:	20
Tradenames:	1
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	4
Patent Applications:	583
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LAROTRECTINIB SULFATE
DailyMed Link:	LAROTRECTINIB SULFATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LAROTRECTINIB SULFATE

Generic Entry Dates for LAROTRECTINIB SULFATE^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 10,799,505 Dosage: CAPSULE;ORAL
Generic Entry Dates for LAROTRECTINIB SULFATE^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 10,137,127 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

See all LAROTRECTINIB SULFATE clinical trials

Pharmacology for LAROTRECTINIB SULFATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Tropomyosin Receptor Kinases Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LAROTRECTINIB SULFATE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for LAROTRECTINIB SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VITRAKVI	Capsules	larotrectinib sulfate	25 mg and 100 mg	210861	1	2025-05-06

US Patents and Regulatory Information for LAROTRECTINIB SULFATE

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Glossary

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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	8,513,263	⤷ Start Trial	Y	Y		⤷ Start Trial
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	11,974,998	⤷ Start Trial				⤷ Start Trial
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	10,172,861	⤷ Start Trial		Y		⤷ Start Trial
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	11,337,967	⤷ 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

International Patents for LAROTRECTINIB SULFATE

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Country	Patent Number	Title	Estimated Expiration
Argentina	074052		⤷ Start Trial
Argentina	112833		⤷ Start Trial
Australia	2009308465		⤷ Start Trial
Australia	2015200511		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LAROTRECTINIB SULFATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	202040008	Slovenia	⤷ Start Trial	PRODUCT NAME: LAROTRECTINIB AND/OR ITS PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY LAROTRECTINIB SULPHATE, INCLUDING LAROTRECTINIB HYDROGEN SULPHATE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1385; DATE OF NATIONAL AUTHORISATION: 20190919; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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	11/2020	Austria	⤷ Start Trial	PRODUCT NAME: LAROTRECTINIB UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFAT, EINSCHLIESSLICH LAROTRECTINIBHYDROGENSULFAT; REGISTRATION 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
>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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.