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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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Pexidartinib hydrochloride has one hundred and six patent family members in thirty-eight countries.
One supplier is listed for this compound.
Summary for pexidartinib hydrochloride
| International Patents: | 106 |
| US Patents: | 9 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 7 |
| Clinical Trials: | 9 |
| Patent Applications: | 7 |
| DailyMed Link: | pexidartinib hydrochloride at DailyMed |
Recent Clinical Trials for pexidartinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Daiichi Sankyo, Inc. | Early Phase 1 |
| Daiichi Sankyo, Inc. | Phase 1 |
| Array BioPharma | Phase 1 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810-001 | Aug 2, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810-001 | Aug 2, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810-001 | Aug 2, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810-001 | Aug 2, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Daiichi Sankyo Inc | TURALIO | pexidartinib hydrochloride | CAPSULE;ORAL | 211810-001 | Aug 2, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 pexidartinib hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | I660956 | Start Trial |
| Denmark | 3292123 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2016179415 | Start Trial |
| Hong Kong | 1248675 | Start Trial |
| Slovenia | 2086972 | Start Trial |
| European Patent Office | 3581573 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
