Fedratinib hydrochloride - Generic Drug Details
✉ Email this page to a colleague
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 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
*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 | ⤷ 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 | ⤷ 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 | Y | Y | ⤷ Sign Up | ||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 |
|---|---|---|---|
| Lithuania | PA2021509 | ⤷ Sign Up | |
| South Africa | 200804083 | Bi-aryl meta-pyrimidine inhibitors of kinases | ⤷ Sign Up |
| European Patent Office | 4159216 | COMPOSITIONS DE TRAITEMENT DE LA MYÉLOFIBROSE (COMPOSITIONS FOR TREATING MYELOFIBROSIS) | ⤷ Sign Up |
| Brazil | PI0618179 | inibidores de biaril meta pirimidina de cinases | ⤷ Sign Up |
| Israel | 226101 | פורמולציות קפסולה של n-טרט-בוטיל-3-[(5 -מתיל-2-{[4-(2 -פירולידין-1-אילאתוקסי(פניל[אמינו{פירימידין-4-איל)אמינו]בנזינסולפונאמיד ושימוש בהן להכנת תרופות לטיפול במיאלופיברוזיס (Capsule formulations of n-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide and use thereof in the preparation of medicaments for treating myelofibrosis) | ⤷ Sign Up |
| Russian Federation | 2012103851 | БИ-АРИЛ-МЕТА-ПИРИМИДИНОВЫЕ ИНГИБИТОРЫ КИНАЗ | ⤷ Sign Up |
| Serbia | 63996 | KOMPOZICIJE ZA LEČENJE MIJELOFIBROZE (COMPOSITIONS FOR TREATING MYELOFIBROSIS) | ⤷ 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 | SPC/GB21/026 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: FEDRATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE HYDRATE THEREOF, IN PARTICULAR FEDRATINIB DIHYDROCHLORIDE MONOHYDRATE; REGISTERED: UK EU/1/20/1514(FOR NI) 20210209; UK FURTHER MA ON IPSUM 20210209 |
| 1951684 | 122021000023 | Germany | ⤷ Sign Up | 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 | 14/2021 | Austria | ⤷ Sign Up | 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 | LUC00204 | Luxembourg | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | CR 2021 00011 | Denmark | ⤷ Sign Up | 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
