You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Harvard Business School

Last Updated: January 15, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212018

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 212018 describes BALVERSA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the BALVERSA profile page.

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 212018
Applicant:Janssen Biotech
Generic Entry Opportunity Date for 212018
Generic Entry Date for 212018*:
Constraining patent/regulatory exclusivity:

*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.

Suppliers and Packaging for NDA: 212018
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BALVERSA erdafitinib TABLET;ORAL 212018 NDA Janssen Products LP 59676-030 59676-030-56 1 BOTTLE in 1 CARTON (59676-030-56) > 56 TABLET, FILM COATED in 1 BOTTLE
BALVERSA erdafitinib TABLET;ORAL 212018 NDA Janssen Products LP 59676-030 59676-030-84 1 BOTTLE in 1 CARTON (59676-030-84) > 84 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Apr 12, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 12, 2024
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:May 22, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Apr 28, 2031Product Flag?Substance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.