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 |
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
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 1/Phase 2 |
Pharmacology for TURALIO
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
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 |