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Last Updated: March 29, 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:133
US Patents:12
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 66
Clinical Trials: 1
Patent Applications: 293
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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthesis of a compound that modulates kinases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations of a compound modulating kinases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Formulations of a compound modulating kinases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds modulating c-fms and/or c-kit activity
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Kinase modulation, and indications therefor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting TURALIO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-002 Oct 14, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-001 Aug 2, 2019 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 2019028235
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 70505
Estimated Expiration: ⤷  Try a Trial

China

Patent: 0944670
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 58189
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 70030
Estimated Expiration: ⤷  Try a Trial

Patent: 20528884
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2615829
Estimated Expiration: ⤷  Try a Trial

Patent: 200032683
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 05599
Estimated Expiration: ⤷  Try a Trial

Patent: 1907920
Estimated Expiration: ⤷  Try a Trial

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
China 112574196 调节激酶的1H-吡咯并[2,3-b]吡啶衍生物的合成 (Synthesis of 1H-pyrrolo[2,3-b]pyridin derivatives that modulate kinases) ⤷  Try a Trial
Japan 2018515490 キナーゼを調節する化合物の固体形態 ⤷  Try a Trial
Norway 342175 ⤷  Try a Trial
>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.