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Last Updated: November 2, 2024

Pexidartinib hydrochloride - Generic Drug Details


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What are the generic sources for pexidartinib hydrochloride and what is the scope of patent protection?

Pexidartinib hydrochloride is the generic ingredient in one branded drug marketed by Daiichi Sankyo Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pexidartinib hydrochloride has one hundred and thirty-five patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for pexidartinib hydrochloride
International Patents:135
US Patents:12
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 23
Clinical Trials: 17
Patent Applications: 28
What excipients (inactive ingredients) are in pexidartinib hydrochloride?pexidartinib hydrochloride excipients list
DailyMed Link:pexidartinib hydrochloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pexidartinib hydrochloride
Generic Entry Date for pexidartinib hydrochloride*:
Constraining patent/regulatory exclusivity:
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 pexidartinib hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Daiichi Sankyo Co., Ltd.Phase 2
Daiichi Sankyo, Inc.Phase 4
Daiichi Sankyo Co., Ltd.Phase 3

See all pexidartinib hydrochloride clinical trials

US Patents and Regulatory Information for pexidartinib hydrochloride

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 211810-002 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 211810-001 Aug 2, 2019 DISCN 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 pexidartinib hydrochloride

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
>Country >Patent Number >Title >Estimated Expiration

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