Gilteritinib fumarate - Generic Drug Details
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What are the generic sources for gilteritinib fumarate and what is the scope of patent protection?
Gilteritinib fumarate
is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Gilteritinib fumarate has seventy-five patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for gilteritinib fumarate
International Patents: | 75 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 14 |
Clinical Trials: | 3 |
Patent Applications: | 85 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for gilteritinib fumarate |
DailyMed Link: | gilteritinib fumarate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for gilteritinib fumarate
Generic Entry Date for gilteritinib fumarate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 gilteritinib fumarate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
City of Hope Medical Center | Phase 1 |
National Cancer Institute (NCI) | Phase 1 |
Children's Oncology Group | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for gilteritinib fumarate
Paragraph IV (Patent) Challenges for GILTERITINIB FUMARATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XOSPATA | Tablets | gilteritinib fumarate | 40 mg | 211349 | 1 | 2022-11-28 |
US Patents and Regulatory Information for gilteritinib fumarate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | 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 gilteritinib fumarate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2017006855 | ⤷ Sign Up | |
Russian Federation | 2011149799 | ДИАМИНОГЕТЕРОЦИКЛИЧЕСКОЕ КАРБОКСАМИДНОЕ СОЕДИНЕНИЕ | ⤷ Sign Up |
Japan | 5364159 | ⤷ Sign Up | |
Japan | WO2010128659 | ジアミノへテロ環カルボキサミド化合物 | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for gilteritinib fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2428508 | 122020000004 | Germany | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
2428508 | C202030004 | Spain | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB O UNA SAL DEL MISMO NOMBRE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1399; DATE OF AUTHORISATION: 20191024; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1399; DATE OF FIRST AUTHORISATION IN EEA: 20191024 |
2428508 | 718 | Finland | ⤷ Sign Up | |
2428508 | 2090007-2 | Sweden | ⤷ Sign Up | PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |