Pexidartinib hydrochloride - Generic Drug Details

What are the generic sources for pexidartinib hydrochloride and what is the scope of freedom to operate?

Pexidartinib hydrochloride is the generic ingredient in one branded drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pexidartinib hydrochloride has one hundred and thirty-five patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for pexidartinib hydrochloride

International Patents:	135
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	17
Patent Applications:	28
What excipients (inactive ingredients) are in pexidartinib hydrochloride?	pexidartinib hydrochloride excipients list
DailyMed Link:	pexidartinib hydrochloride at DailyMed

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

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.

Recent Clinical Trials for pexidartinib hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Daiichi Sankyo Co., Ltd.	Phase 2
Daiichi Sankyo, Inc.	Phase 4
Daiichi Sankyo Co., Ltd.	Phase 3

See all pexidartinib hydrochloride clinical trials

Pharmacology for pexidartinib hydrochloride

Drug Class	Kinase Inhibitor
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

US Patents and Regulatory Information for pexidartinib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No				Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No				Y
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No

International Patents for pexidartinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4295912	COMPOSÉS ET PROCÉDÉS POUR UNE MODULATION DE LA KINASE, ET INDICATIONS CORRESPONDANTES (COMPOUNDS AND METHODS FOR KINASE MODULATION, AND INDICATIONS THEREFOR)
Brazil	112017023490	formas sólidas de um composto modulando quinases
Philippines	12017501995	SOLID FORMS OF A COMPOUND MODULATING KINASES
European Patent Office	3292122	SYNTHÈSE DE DÉRIVÉS 1H-PYRROLO[2,3-B]PYRIDINE QUI MODULENT LES KINASES (SYNTHESIS OF 1H-PYRROLO[2,3-B]PYRIDIN DERIVATIVES THAT MODULATE KINASES)
China	103497188	Compounds modulating c-fms and/or c-kit activity and uses therefor
Taiwan	I805599