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BALVERSA Drug Profile
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» See Plans and PricingWhich patents cover Balversa, and when can generic versions of Balversa launch?
Balversa is a drug marketed by Janssen Biotech and is included in one NDA. There are three patents protecting this drug.
This drug has ninety-two 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.
US ANDA Litigation and Generic Entry Outlook for Balversa
Balversa will be eligible for patent challenges on April 12, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 26, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for BALVERSA
| International Patents: | 92 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 1 |
| Patent Applications: | 17 |
| 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 | Start Trial | ||||
| Janssen Biotech | BALVERSA | erdafitinib | TABLET;ORAL | 212018-002 | Apr 12, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Y | 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 | ||||
| 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 | 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 BALVERSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 201500278 | Start Trial |
| Japan | 6625551 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011135376 | Start Trial |
| Hong Kong | 1211922 | Start Trial |
| South Africa | 201606942 | Start Trial |
| Ecuador | SP12012318 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
