LAROTRECTINIB SULFATE - Generic Drug Details

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 eleven patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for LAROTRECTINIB SULFATE

International Patents:	211
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

Dosage:

CAPSULE;ORAL

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

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
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No			Y	Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No

International Patents for LAROTRECTINIB SULFATE

Country	Patent Number	Title	Estimated Expiration
Argentina	108090	FORMULACIONES LÍQUIDAS DE (S)-N-(5-((R)-2-(2,5-DIFLUOROFENIL)-PIRROLIDIN-1-IL)-PIRAZOLO[1,5-A]PIRIMIDIN-3-IL)-3-HIDROXIPIRROLIDINA-1-CARBOXAMIDA
Peru	20181888	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
Singapore	10201914059W	SUBSTITUTED PYRAZOLO[1,5-A]PYRIMIDINE COMPOUNDS AS TRK KINASE INHIBITORS
Brazil	112018070017	métodos de tratamento de cânceres pediátricos
Canada	3019661	METHODES DE TRAITEMENT DE CANCERS PEDIATRIQUES (METHODS OF TREATING PEDIATRIC CANCERS)
Taiwan	I639605
Georgia, Republic of	P20227339	LIQUID FORMULATIONS OF (S)-N-(5-((R)-2-(2,5-DIFLUOROPHENYL)-PYRROLIDIN-1-YL)- PYRAZOLO[1,5-A]PYRIMIDIN-3-YL)-3-HYDRO-XYPYRROLIDINE-1-CARBOXAMIDE

Supplementary Protection Certificates for LAROTRECTINIB SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	2020/009	Ireland		PRODUCT NAME: LAROTRECTINIB AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REGISTRATION NO/DATE: EU/1/19/1385 20190923
3106463	2020004	Norway		PRODUCT NAME: LAROTREKTINIB OG/ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV, SAERLIG LAROTREKTINIBSULFAT INKLUDERT LAROTREKTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20191018
3106463	132020000000025	Italy		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	C03106463/01	Switzerland		PRODUCT NAME: LAROTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67282 28.05.2020
3106463	2090009-8	Sweden		PRODUCT NAME: LAROTRECTINIB,OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REG. NO/DATE: EU/1/19/1385 20190923
3106463	C202030011	Spain		PRODUCT NAME: LAROTRECTINIB Y/O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, PARTICULARMENTE SULFATO DE LAROTRECTINIB QUE INCLUYE HIDROGENOSULFATO DE LAROTRECTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/19/1385; DATE OF AUTHORISATION: 20190919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1385; DATE OF FIRST AUTHORISATION IN EEA: 20190919
3106463	301033	Netherlands		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