Erdafitinib - Generic Drug Details
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What are the generic drug sources for erdafitinib and what is the scope of freedom to operate?
Erdafitinib
is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Erdafitinib has two hundred and eighty-three patent family members in forty-eight countries.
One supplier is listed for this compound.
Summary for erdafitinib
International Patents: | 283 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 52 |
Clinical Trials: | 27 |
Patent Applications: | 672 |
What excipients (inactive ingredients) are in erdafitinib? | erdafitinib excipients list |
DailyMed Link: | erdafitinib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for erdafitinib
Generic Entry Date for erdafitinib*:
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 erdafitinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Memorial Sloan Kettering Cancer Center | Phase 2 |
M.D. Anderson Cancer Center | Phase 2 |
University of Washington | Phase 2 |
Pharmacology for erdafitinib
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BALVERSA | Tablets | erdafitinib | 3 mg, 4 mg and 5 mg | 212018 | 1 | 2023-04-12 |
US Patents and Regulatory Information for erdafitinib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-003 | Apr 12, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-002 | Apr 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-001 | Apr 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-001 | Apr 12, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 erdafitinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2018511611 | 癌治療のためのFGFR/PD−1併用療法 | ⤷ Sign Up |
Colombia | 2017003528 | Uso de paneles de genes mutantes de fgfr en la identificación de pacientes con cáncer que responderán al tratamiento con un inhibidor de fgfr | ⤷ Sign Up |
Taiwan | 201839399 | Cancer treatment | ⤷ Sign Up |
Canada | 2943683 | DERIVES DE QUINOXALINE UTILES EN TANT QUE MODULATEURS DE LA KINASE FGFR (QUINOXALINE DERIVATIVES USEFUL AS FGFR KINASE MODULATORS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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