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Last Updated: September 27, 2022

TURALIO Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Turalio

Turalio will be eligible for patent challenges on August 2, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:125
US Patents:12
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 56
Clinical Trials: 1
Patent Applications: 305
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 Generic Entry Opportunity 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 two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TURALIO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthesis of a compound that modulates kinases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of a compound modulating kinases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of a compound modulating kinases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds modulating c-fms and/or c-kit activity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Kinase modulation, and indications therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting TURALIO

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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-001 Aug 2, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-001 Aug 2, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-001 Aug 2, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2019028235
Estimated Expiration: See Plans and Pricing

Canada

Patent: 70505
Estimated Expiration: See Plans and Pricing

China

Patent: 0944670
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 58189
Estimated Expiration: See Plans and Pricing

Japan

Patent: 20528884
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 200032683
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1907920
Estimated Expiration: See Plans and Pricing

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
European Patent Office 2086972 COMPOSÉS MODULANT L'ACTIVITÉ DE C-FMS ET/OU DE C-KIT ET UTILISATIONS ASSOCIÉES (COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREFOR) See Plans and Pricing
New Zealand 577011 COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREFOR See Plans and Pricing
Japan 2020528884 キナーゼを調節する化合物の製剤 See Plans and Pricing
European Patent Office 3757104 FORMES SOLIDES D'UN COMPOSÉ MODULANT LES KINASES (SOLID FORMS OF A COMPOUND MODULATING KINASES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
McKesson
Dow
Moodys
Harvard Business School

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.