PEXIDARTINIB HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for pexidartinib hydrochloride and what is the scope of patent protection?

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

Generic Entry Date for PEXIDARTINIB HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for PEXIDARTINIB HYDROCHLORIDE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PEXIDARTINIB HYDROCHLORIDE

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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
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-002	Oct 14, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ 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 PEXIDARTINIB HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Canada	2670362	COMPOSES MODULANT L'ACTIVITE DE C-FMS ET/OU DE C-KIT ET UTILISATIONS ASSOCIEES (COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREFOR)	⤷ Sign Up
Cyprus	1115288		⤷ Sign Up
Japan	2018021055	Ｃ−ＦＭＳおよび／またはＣ−ＫＩＴ活性を調節する化合物およびその用途 (COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREOF)	⤷ Sign Up
Argentina	063878	COMPUESTOS DE PIRROL-PIRIDINA Y COMPOSICION FARMACEUTICA	⤷ Sign Up
Poland	2086972		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013142427		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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