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
Sponsor | Phase |
---|---|
Daiichi Sankyo Co., Ltd. | Phase 2 |
Daiichi Sankyo, Inc. | Phase 4 |
Daiichi Sankyo Co., Ltd. | Phase 3 |
Pharmacology 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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