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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Erdafitinib has ninety-five patent family members in forty countries.
One supplier is listed for this compound.
Summary for erdafitinib
International Patents: | 95 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 38 |
Clinical Trials: | 15 |
Patent Applications: | 39 |
What excipients (inactive ingredients) are in erdafitinib? | erdafitinib excipients list |
DailyMed Link: | erdafitinib at DailyMed |
Recent Clinical Trials for erdafitinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Phase 1 |
University of Washington | Phase 2 |
Lung Cancer Group Cologne | Phase 2 |
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-002 | Apr 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-002 | Apr 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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 erdafitinib
Country | Patent Number | Estimated Expiration |
---|---|---|
Hungary | E045893 | Start Trial |
United Kingdom | 201007286 | Start Trial |
Cyprus | 1120969 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |