Gilteritinib fumarate - Generic Drug Details
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What are the generic drug sources for gilteritinib fumarate and what is the scope of freedom to operate?
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-seven patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for gilteritinib fumarate
International Patents: | 77 |
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: | 45 |
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 |
---|---|
National Cancer Institute (NCI) | Phase 1 |
City of Hope Medical Center | 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 | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Astellas | XOSPATA | gilteritinib fumarate | TABLET;ORAL | 211349-001 | Nov 28, 2018 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
>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 |
---|---|---|---|
Lithuania | PA2020002 | ⤷ Try for Free | |
Taiwan | I756177 | ⤷ Try for Free | |
Portugal | 3009428 | ⤷ Try for Free | |
Lithuania | 3009428 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for gilteritinib fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2428508 | 2090007-2 | Sweden | ⤷ Try for Free | PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028 |
2428508 | PA2020002 | Lithuania | ⤷ Try for Free | PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024 |
2428508 | 301028 | Netherlands | ⤷ Try for Free | PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028 |
2428508 | 2020001 | Norway | ⤷ Try for Free | PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAV; REG. NO/DATE: EU/1/19/1399 20191030 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Gilteritinib Fumarate
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