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Fedratinib hydrochloride - Generic Drug Details
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What are the generic drug sources for fedratinib hydrochloride and what is the scope of freedom to operate?
Fedratinib hydrochloride
is the generic ingredient in one branded drug marketed by Impact and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fedratinib hydrochloride has seventy-nine patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for fedratinib hydrochloride
| International Patents: | 79 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 9 |
| DailyMed Link: | fedratinib hydrochloride at DailyMed |
Recent Clinical Trials for fedratinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Celgene | Phase 1/Phase 2 |
| Ascentage Pharma Group Inc. | Phase 1/Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
US Patents and Regulatory Information for fedratinib hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Impact | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 fedratinib hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 201306882 | Start Trial |
| South Korea | 20130137647 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007053452 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
