Fedratinib hydrochloride - Generic Drug Details
✉ Email this page to a colleague
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 Bristol-myers and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fedratinib hydrochloride has one hundred and ten patent family members in forty countries.
One supplier is listed for this compound.
Summary for fedratinib hydrochloride
International Patents: | 110 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 30 |
Clinical Trials: | 23 |
Patent Applications: | 18 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for fedratinib hydrochloride |
What excipients (inactive ingredients) are in fedratinib hydrochloride? | fedratinib hydrochloride excipients list |
DailyMed Link: | fedratinib hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fedratinib hydrochloride
Generic Entry Date for fedratinib 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 fedratinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Joseph Jurcic | Phase 1 |
Celgene International II S.á.r.l. | Phase 2 |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for fedratinib hydrochloride
Paragraph IV (Patent) Challenges for FEDRATINIB HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
INREBIC | Capsules | fedratinib hydrochloride | 100 mg | 212327 | 1 | 2023-08-16 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 fedratinib hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ecuador | SP13012658 | COMPOSICIONES Y MÉTODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS | ⤷ Sign Up |
Norway | 20082447 | ⤷ Sign Up | |
Japan | 5814903 | ⤷ Sign Up | |
Ukraine | 109411 | N-ТРЕТ-БУТИЛ-3-(2-ХЛОР-5-МЕТИЛПІРИМІДИН-4-ІЛАМІНО)БЕНЗОЛСУЛЬФОНАМІД ТА ЙОГО ЗАСТОСУВАННЯ В СПОСОБІ ОДЕРЖАННЯ СПОЛУКИ | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fedratinib hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1951684 | PA2021509,C1951684 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FEDRATINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA FARMACINIU POZIURIU PRIIMTINAS JO HIDRATAS, YPAC FEDRATINIBO DIHIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/20/1514 20210208 |
1951684 | C 2021 012 | Romania | ⤷ Sign Up | PRODUCT NAME: FEDRATINIB, SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, SAU UN HIDRAT ACCEPTABIL FARMACEUTIC AL ACESTUIA, IN PARTICULAR DICLORHIDRAT DE FEDRATINIB MONOHIDRAT; NATIONAL AUTHORISATION NUMBER: EU/1/20/1514; DATE OF NATIONAL AUTHORISATION: 20210208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1514; DATE OF FIRST AUTHORISATION IN EEA: 20210208 |
1951684 | PA2021509 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FEDRATINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA FARMACINIU POZIURIU PRIIMTINAS JO HIDRATAS, YPAC FEDRATINIBO DIHIDROCHLORIDO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/20/1514 20210208 |
1951684 | 21C1019 | France | ⤷ Sign Up | PRODUCT NAME: FEDRATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, OU UN HYDRATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE DICHLORHYDRATE DE FEDRATINIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/20/1514 20210209 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |