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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Erdafitinib has one hundred and sixty-three patent family members in forty-one countries.
One supplier is listed for this compound.
Summary for erdafitinib
| International Patents: | 163 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 41 |
| Clinical Trials: | 24 |
| Patent Applications: | 433 |
| 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 |
|---|---|
| Memorial Sloan Kettering Cancer Center | Phase 2 |
| M.D. Anderson Cancer Center | Phase 2 |
| University of Washington | 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-003 | Apr 12, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-002 | Apr 12, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-001 | Apr 12, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-003 | Apr 12, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 |
|---|---|---|---|
| Australia | 2017202512 | PYRAZOLYL QUINOXALINE KINASE INHIBITORS | See Plans and Pricing |
| European Patent Office | 3590934 | INHIBITEURS DE KINASE DE QUINOXALINE PYRAZOLYLE (PYRAZOLYL QUINOXALINE KINASE INHIBITORS) | See Plans and Pricing |
| Israel | 281024 | See Plans and Pricing | |
| Mexico | 2019009304 | TRATAMIENTO PARA EL CANCER. (CANCER TREATMENT.) | See Plans and Pricing |
| South Korea | 20170110145 | N--N'--N-[3-(1-메틸-1H-피라졸-4-일)퀴녹살린-6-일]에탄-1,2-디아민을 포함하는 제약 조성물 | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
