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

Larotrectinib sulfate has two hundred and twenty-three patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for larotrectinib sulfate

International Patents:	223
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;ORAL
Generic Entry Dates for larotrectinib sulfate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
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	210861-002	Nov 26, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Poland	3699181		⤷ Sign Up
China	103509017	Substituted pyrazolo[1,5-a]pyrimidine compounds as TRK kinase inhibitors	⤷ Sign Up
Japan	2019511575	（Ｓ）−Ｎ−（５−（（Ｒ）−２−（２，５−ジフルオロフェニル）−ピロリジン−１−イル）−ピラゾロ［１，５−ａ］ピリミジン−３−イル）−３−ヒドロキシピロリジン−１−カルボキサミドの液体製剤	⤷ Sign Up
Australia	2017246547		⤷ Sign Up
Denmark	3699181		⤷ Sign Up
Chile	2019002238	Formulaciones liquidas de (s)-n-(5-((r)-2-(2,5-difluorofenil)-pirrolidin-1-il)-pirazolo[1,5-a]pirimidin-3-il)-3 hidroxipirrolidina -1-carboxamida. (divisional solicitud 201802806)	⤷ Sign Up
>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	SPC/GB20/013	United Kingdom	⤷ Sign Up	PRODUCT NAME: LAROTRECITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PARTICULARLY LAROTRECITINIB SULFATE INCLUDING LAROTRECITINIB HYDROGEN SULFATE; REGISTERED: UK EU/1/19/1385(NI) 20190923; UK PLGB 00010/0741 20190923; UK PLGB 00010/0742 20190923; UK PLGB 00010/0743 20190923
3106463	CR 2020 00013	Denmark	⤷ Sign Up	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	⤷ Sign Up	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	C20200005 00308	Estonia	⤷ Sign Up	PRODUCT NAME: LAROTREKTINIIB;REG NO/DATE: EU/1/19/1385; 23.09.2019
3106463	C03106463/01	Switzerland	⤷ Sign Up	PRODUCT NAME: LAROTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67282 28.05.2020
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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