Fedratinib hydrochloride - Generic Drug Details
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What are the generic 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 nine patent family members in forty countries.
One supplier is listed for this compound.
Summary for fedratinib hydrochloride
| International Patents: | 109 |
| 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 |
| Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Phase 2 |
| Celgene International II S.á.r.l. | 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
International Patents for fedratinib hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2012103851 | БИ-АРИЛ-МЕТА-ПИРИМИДИНОВЫЕ ИНГИБИТОРЫ КИНАЗ | ⤷ Try a Trial |
| Taiwan | 201306882 | Compositions and methods for treating myelofibrosis | ⤷ Try a Trial |
| Morocco | 34723 | COMPOSITIONS ET MÉTHODES DE TRAITEMENT DE LA MYÉLOFIBROSE | ⤷ Try a Trial |
| Taiwan | 200804308 | Biaryl meta-pyrimidine inhibitors of kinases | ⤷ Try a Trial |
| Singapore | 190134 | COMPOSITIONS AND METHODS FOR TREATING MYELOFIBROSIS | ⤷ Try a Trial |
| Singapore | 11202103019W | METHODS OF TREATING MYELOPROLIFERATIVE DISORDERS | ⤷ Try a Trial |
| New Zealand | 611363 | Compositions and methods for treating myelofibrosis | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for fedratinib hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1951684 | LUC00204 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/20/1514 20210209 |
| 1951684 | CA 2021 00011 | Denmark | ⤷ Try a Trial | 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 | 122021000023 | Germany | ⤷ Try a Trial | 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 |
| 1951684 | C01951684/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FEDRATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67792 01.07.2021 |
| 1951684 | C202130029 | Spain | ⤷ Try a Trial | 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 | 2190016-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; REG. NO/DATE: EU/1/20/1514 20210209 |
| 1951684 | PA2021509 | Lithuania | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
