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 twenty-nine 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
Summary for TURALIO
| International Patents: | 129 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| 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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 ⤷ 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 | ||||
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810-001 | Aug 2, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | Y | ⤷ 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: 200032683
Estimated Expiration: ⤷ Try a Trial
Taiwan
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 |
|---|---|---|---|
| Canada | 2867918 | COMPOSES ET PROCEDES POUR UNE MODULATION DE LA KINASE, ET INDICATIONS CORRESPONDANTES (COMPOUNDS AND METHODS FOR KINASE MODULATION, AND INDICATIONS THEREFOR) | ⤷ Try a Trial |
| Japan | 2015205880 | 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 (COMPOUND FOR MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USE THEREFOR) | ⤷ Try a Trial |
| Poland | 2086972 | ⤷ Try a Trial | |
| Slovenia | 2086972 | ⤷ Try a Trial | |
| Singapore | 176511 | COMPOUNDS MODULATING C-FMS AND/OR C-KIT ACTIVITY AND USES THEREFOR | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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.
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