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TURALIO Drug Patent Profile

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Which patents cover Turalio, and what generic alternatives are available?

Turalio is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and thirty-five patent family members in forty-one countries.

The generic ingredient in TURALIO is pexidartinib hydrochloride. One supplier is listed for this compound. Additional details are available on the pexidartinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Turalio

Turalio was eligible for patent challenges on August 2, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 24, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TURALIO

International Patents:	135
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	1
Patent Applications:	226
Drug Prices:	Drug price information for TURALIO
What excipients (inactive ingredients) are in TURALIO?	TURALIO excipients list
DailyMed Link:	TURALIO at DailyMed

Drug patent expirations by year for TURALIO

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

Generic Entry Date for TURALIO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 211810 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 TURALIO

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1/Phase 2

See all TURALIO clinical trials

Pharmacology for TURALIO

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 TURALIO

TURALIO is protected by twelve US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TURALIO is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TURALIO

Solid forms of a compound modulating kinases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Formulations of a compound modulating kinases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Synthesis of a compound that modulates kinases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Formulations of a compound modulating kinases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Formulations of a compound modulating kinases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compounds modulating c-fms and/or c-kit activity
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Kinase modulation, and indications therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Solid forms of a compound modulating kinases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting TURALIO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up

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
Exclusivity Expiration: ⤷ Sign Up

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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	211810-001	Aug 2, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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	211810-002	Oct 14, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 TURALIO

When does loss-of-exclusivity occur for TURALIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 18307910
Patent: Formulations of a compound modulating kinases
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2019028235
Patent: formulações de cinases moduladoras de um composto
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 70505
Patent: FORMULATION D'UN COMPOSE MODULANT LES KINASES (FORMULATIONS OF A COMPOUND MODULATING KINASES)
Estimated Expiration: ⤷ Sign Up

China

Patent: 0944670
Patent: 调制激酶的化合物的制剂 (Formulations of a compound modulating kinases)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 58189
Patent: FORMULATION D'UN COMPOSÉ MODULANT LES KINASES (FORMULATIONS OF A COMPOUND MODULATING KINASES)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 70030
Estimated Expiration: ⤷ Sign Up

Patent: 20528884
Patent: キナーゼを調節する化合物の製剤
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2615829
Estimated Expiration: ⤷ Sign Up

Patent: 200032683
Patent: 키나제를 조정하는 화합물의 제제
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 05599
Estimated Expiration: ⤷ Sign Up

Patent: 1907920
Patent: Formulations of a Compound modulating kinases
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TURALIO around the world.

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2730506	ТВЕРДЫЕ ФОРМЫ СОЕДИНЕНИЯ, МОДУЛИРУЮЩЕГО КИНАЗЫ (SOLID FORMS OF THE COMPOUND MODULATING THE KINASES)	⤷ Sign Up
Spain	2923943		⤷ Sign Up
European Patent Office	3292123	FORMES SOLIDES D'UN COMPOSÉ MODULANT LES KINASES (SOLID FORMS OF A COMPOUND MODULATING KINASES)	⤷ Sign Up
China	103497188	Compounds modulating c-fms and/or c-kit activity and uses therefor	⤷ Sign Up
Malaysia	192352	SOLID FORMS OF A COMPOUND MODULATING KINASES	⤷ Sign Up
Norway	20091989		⤷ Sign Up
Australia	2017254821	Compounds and methods for kinase modulation, and indications therefor	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration