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Last Updated: February 7, 2023

Pexidartinib hydrochloride - Generic Drug Details


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What are the generic sources for pexidartinib hydrochloride and what is the scope of freedom to operate?

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 twenty-seven patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for pexidartinib hydrochloride
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 211810-001 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 211810-002 Oct 14, 2022 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-002 Oct 14, 2022 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-002 Oct 14, 2022 RX Yes No 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 211810-002 Oct 14, 2022 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Daiichi Sankyo Inc TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810-002 Oct 14, 2022 RX Yes No See Plans and Pricing See Plans and Pricing 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 pexidartinib hydrochloride

Country Patent Number Title Estimated Expiration
Japan 2018515490 キナーゼを調節する化合物の固体形態 See Plans and Pricing
Israel 255313 See Plans and Pricing
China 110944670 调制激酶的化合物的制剂 (Formulations of a compound modulating kinases) See Plans and Pricing
Australia 2018307910 Formulations of a compound modulating kinases See Plans and Pricing
Japan 6946194 See Plans and Pricing
Hong Kong 1248675 調節激酶的1H 吡咯並[2,3-B]吡啶衍生物的合成 (SYNTHESIS OF 1 H-PYRROLO[2,3-B]PYRIDIN DERIVATIVES THAT MODULATE KINASES) See Plans and Pricing
Japan 6986045 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Merck
McKesson
Johnson and Johnson
Moodys

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.