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	210861-001	Nov 26, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	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 Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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
Taiwan	I458729		⤷ Sign Up
Denmark	3439662		⤷ Sign Up
Morocco	44610		⤷ Sign Up
Poland	3439662		⤷ 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	2020/009	Ireland	⤷ Sign Up	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	2090009-8	Sweden	⤷ Sign Up	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	2020C/507	Belgium	⤷ Sign Up	PRODUCT NAME: VITRAKVI - LAROTRECTINIB ET/OU SES SELS ACCEPTABLES EN PHARMACIE, EN PARTICULIER L'HYDROGENO SULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
3106463	132020000000025	Italy	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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