LAROTRECTINIB SULFATE - Generic Drug Details

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 ten patent family members in fifty countries.

Two suppliers are listed for this compound.

Summary for LAROTRECTINIB SULFATE

International Patents:	210
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 Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes
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			Y	Y

International Patents for LAROTRECTINIB SULFATE

Country	Patent Number	Title	Estimated Expiration
China	113354649	一种新的晶型 (Novel crystalline form)
Spain	2941630
Portugal	3106463
South Korea	20160104085	ＴＲＫ 키나아제 억제제로서 치환된 피라졸로［１,５­ａ］ 피리미딘 화합물 (SUBSTITUTED PYRAZOLO[1,5-A]PYRIMIDINE COMPOUNDS AS TRK KINASE INHIBITORS)

Supplementary Protection Certificates for LAROTRECTINIB SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	PA2020504,C3106463	Lithuania		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	11/2020	Austria		PRODUCT NAME: LAROTRECTINIB UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFAT, EINSCHLIESSLICH LAROTRECTINIBHYDROGENSULFAT; REGISTRATION 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	C20200005 00308	Estonia		PRODUCT NAME: LAROTREKTINIIB;REG NO/DATE: EU/1/19/1385; 23.09.2019