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Last Updated: November 2, 2024

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TURALIO Drug Patent Profile


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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
Drug Prices for TURALIO

See drug prices for TURALIO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TURALIO
Generic Entry Date for TURALIO*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all TURALIO clinical trials

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 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

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

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.

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
Taiwan I805599 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.