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Fedratinib hydrochloride - Generic Drug Details
What are the generic sources for fedratinib hydrochloride and what is the scope of patent protection?
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-six patent family members in thirty-three countries.
One supplier is listed for this compound.
Summary for fedratinib hydrochloride
| International Patents: | 76 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 4 |
| DailyMed Link: | fedratinib hydrochloride at DailyMed |
Recent Clinical Trials for fedratinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation | Phase 1 |
| Celgene | Phase 1 |
| Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation | Phase 3 |
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 | 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 | 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 |
|---|---|---|
| Peru | 03892014 | Start Trial |
| Russian Federation | 2012103850 | Start Trial |
| South Korea | 101940979 | Start Trial |
| Brazil | 112013011184 | Start Trial |
| Russian Federation | 2616262 | Start Trial |
| Ukraine | 99899 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
