DrugPatentWatch Database Preview
BALVERSA Drug Profile
Which patents cover Balversa, and what generic alternatives are available?
Balversa is a drug marketed by Janssen Biotech and is included in one NDA. There are three patents protecting this drug.
This drug has eighty-three patent family members in thirty-nine countries.
The generic ingredient in BALVERSA is erdafitinib. One supplier is listed for this compound. Additional details are available on the erdafitinib profile page.
Summary for BALVERSA
| International Patents: | 83 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for BALVERSA |
| DailyMed Link: | BALVERSA at DailyMed |
Generic Entry Opportunity Date for BALVERSA
Generic Entry Date for BALVERSA*:
Constraining patent/regulatory exclusivity:
NDA:
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 BALVERSA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| University of Washington | Phase 2 |
US Patents and Regulatory Information for BALVERSA
| 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 | 212018-001 | Apr 12, 2019 | RX | Yes | No | 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 | 212018-001 | Apr 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-003 | Apr 12, 2019 | RX | Yes | Yes | Start Trial | Start Trial | 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 BALVERSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 023222 | Start Trial |
| Denmark | 2563775 | Start Trial |
| Taiwan | I545122 | Start Trial |
| Croatia | P20182073 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
