Details for New Drug Application (NDA): 211810

NDA 211810 describes TURALIO, which is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the TURALIO profile page.

The generic ingredient in TURALIO is pexidartinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pexidartinib hydrochloride profile page.

Summary for 211810

Tradename:	TURALIO
Applicant:	Daiichi Sankyo Inc
Ingredient:	pexidartinib hydrochloride
Patents:	12

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211810

Constraining patent/regulatory exclusivity:

10,730,876

Dosage:

CAPSULE;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.

Pharmacology for NDA: 211810

Mechanism of Action

Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 3A Inducers Kinase Inhibitors Tyrosine Kinase Inhibitors UGT1A1 Inhibitors

Suppliers and Packaging for NDA: 211810

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810	NDA	Daiichi Sankyo Inc.	65597-407	65597-407-20	1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE
TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810	NDA	Daiichi Sankyo Inc.	65597-407	65597-407-28	1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Aug 2, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 2, 2026
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH SYMPTOMATIC TENOSYNOVIAL GIANT CELL TUMOR (TGCT) ASSOCIATED WITH SEVERE MORBIDITY OR FUNCTIONAL LIMITATIONS AND NOT AMENABLE TO IMPROVEMENT WITH SURGERY
Patent:	10,189,833	Patent Expiration:	May 5, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ADULT PATIENTS WITH SYMPTOMATIC TENOSYNOVIAL GIANT CELL TUMOR (TGCT) ASSOCIATED WITH SEVERE MORBIDITY OR FUNCTIONAL LIMITATIONS AND NOT AMENABLE TO IMPROVEMENT WITH SURGERY
Patent:	10,435,404	Patent Expiration:	Jul 24, 2038	Product Flag?	Y	Substance Flag?		Delist Request?

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