FEDRATINIB HYDROCHLORIDE - Generic Drug Details
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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 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol-myers | INREBIC | fedratinib hydrochloride | CAPSULE;ORAL | 212327-001 | Aug 16, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | E028987 | ⤷ Try a Trial | |
| Lithuania | 2635282 | ⤷ Try a Trial | |
| Ukraine | 109411 | N-ТРЕТ-БУТИЛ-3-(2-ХЛОР-5-МЕТИЛПІРИМІДИН-4-ІЛАМІНО)БЕНЗОЛСУЛЬФОНАМІД ТА ЙОГО ЗАСТОСУВАННЯ В СПОСОБІ ОДЕРЖАННЯ СПОЛУКИ | ⤷ Try a Trial |
| South Korea | 20210102192 | 골수증식성 장애를 치료하는 방법 | ⤷ Try a Trial |
| Russian Federation | 2008121807 | БИ-АРИЛ-МЕТА-ПИРИМИДИНОВЫЕ ИНГИБИТОРЫ КИНАЗЫ | ⤷ 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 | 14/2021 | Austria | ⤷ Try a Trial | 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 | C20210010 00394 | Estonia | ⤷ Try a Trial | PRODUCT NAME: FEDRATINIIB;REG NO/DATE: EU/1/20/1514; 09.02.2021 |
| 1951684 | CR 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 | 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 | 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 |
