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 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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >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 |
|---|---|---|---|
| China | 103282036 | Compositions and methods for treating myelofibrosis | ⤷ Subscribe |
| Netherlands | 301104 | ⤷ Subscribe | |
| Chile | 2013001252 | Capsula para administracion oral que comprende n-terc-butil-3-[(5-metil-2-{[4-(2-pirrolidin-1-iletoxi)fenil]amino}pirimidin-4-il)amino]bencenosulfonamida, una celulosa microcristalina y estearil fumarato de sodio; forma de dosificacion unitaria; metodo para tratar mielofibrosis; metodo de preparacion; y articulo de preparacion. | ⤷ Subscribe |
| Australia | 2019346521 | Methods of treating myeloproliferative disorders | ⤷ Subscribe |
| Canada | 2816957 | COMPOSITIONS ET PROCEDES DE TRAITEMENT DE LA MYELOFIBROSE (COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS) | ⤷ Subscribe |
| Peru | 20140389 | COMPOSICIONES Y METODOS PARA EL TRATAMIENTO DE LA MIELOFIBROSIS | ⤷ Subscribe |
| China | 108125923 | 用于治疗骨髓纤维化的组合物和方法 (Compositions and methods for treating myelofibrosis) | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fedratinib hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1951684 | C01951684/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021 |
| 1951684 | CR 2021 00011 | Denmark | ⤷ Subscribe | PRODUCT NAME: FEDRATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET FARMACEUTISK ACCEPTABELT HYDRAT DERAF, ISAER FEDRATINIB-DIHYDROCHLORIDMONOHYDRAT; REG. NO/DATE: EU/1/20/1514 20210209 |
| 1951684 | CA 2021 00011 | Denmark | ⤷ Subscribe | PRODUCT NAME: FEDRATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF ELLER ET FARMACEUTISK ACCEPTABELT HYDRAT DERAF, ISAER FEDRATINIB-DIHYDROCHLORIDMONOHYDRAT; REG. NO/DATE: EU/1/20/1514 20210209 |
| 1951684 | 14/2021 | Austria | ⤷ Subscribe | PRODUCT NAME: FEDRATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN PHARMAZEUTISCH ANNEHMBARES HYDRAT DAVON, INSBESONDERE FEDRATINIB-DIHYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/20/1514 (MITTEILUNG) 20210209 |
| 1951684 | C202130029 | Spain | ⤷ Subscribe | PRODUCT NAME: FEDRATINIB, O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, O UN HIDRATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR MONOHIDRATO DE DIHIDROCLORURO DE FEDRATINIB; NATIONAL AUTHORISATION NUMBER: EU/1/20/1514; DATE OF AUTHORISATION: 20210208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1514; DATE OF FIRST AUTHORISATION IN EEA: 20210208 |
| 1951684 | 2021C/513 | Belgium | ⤷ Subscribe | 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; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209 |
| 1951684 | 122021000023 | Germany | ⤷ Subscribe | PRODUCT NAME: FEDRATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON ODER EIN PHARMAZEUTISCH UNBEDENKLICHES HYDRAT DAVON, INSBESONDERE FEDRATINIB-DIHYDROCHLORID-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/20/1514 20210208 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
