By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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BALVERSA Drug Profile
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Which 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 four patents protecting this drug.
This drug has one hundred and eighteen patent family members in forty-one countries.
The generic ingredient in BALVERSA is erdafitinib. One supplier is listed for this compound. Additional details are available on the erdafitinib profile page.
DrugPatentWatch® 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 February 9, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for BALVERSA
| International Patents: | 118 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 2 |
| Patent Applications: | 47 |
| Drug Prices: | Drug price information for BALVERSA |
| What excipients (inactive ingredients) are in BALVERSA? | BALVERSA excipients list |
| DailyMed Link: | BALVERSA at DailyMed |
DrugPatentWatch® Estimated 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 |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
| University of Washington | Phase 2 |
US Patents and Regulatory Information for BALVERSA
International Patents for BALVERSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Singapore | 11201706472R | Try Before You Buy |
| Eurasian Patent Organization | 201691940 | Try Before You Buy |
| Singapore | 11201607961Q | Try Before You Buy |
| Japan | 6625551 | Try Before You Buy |
| Colombia | 2017008862 | Try Before You Buy |
| Canada | 2943683 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
