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Balversa · pharmadog

pharmadog
drugs
Balversa

drug · small molecule

patient view →

erdafitinib

Marketedupdated 2mo ago

by $JNJ JOHNSON & JOHNSON🔗 ChEMBL

Approved

community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 11 investigational indications.

targets

Fibroblast growth factor receptor

all catalysts(11)

approval · 11

view all 11 catalysts →

News(0)

no news has mentioned this drug yet

brand

Balversa

trade names

Balversa

generic

erdafitinib

MOA

Fibroblast growth factor receptor inhibitor

indication

Non Muscle Invasive Bladder Cancer (NMIBC) (Superficial Bladder Cancer)

phase

marketed

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

BALVERSA (ERDAFITINIB) — FDA approval

Data sources

openFDA · ClinicalTrials.gov · OpenTargets

last refreshed 55m ago

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Patent cliff

source: FDA Orange Book

first barrier falls

Jan 19, 2027

196 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (24)

Feb 2, 2038method-of-use (U-3808)US 11077106
Feb 2, 2038method-of-use (U-3808)US 11077106
Feb 2, 2038method-of-use (U-3808)US 11077106
Aug 13, 2036method-of-use (U-3902)US 10478494
Aug 13, 2036method-of-use (U-3902)US 10478494
Aug 13, 2036method-of-use (U-3902)US 10478494
Feb 9, 2036formulationUS 10898482
Feb 9, 2036formulationUS 10898482
Feb 9, 2036formulationUS 10898482
Feb 9, 2036method-of-use (U-3806)US 11684620
Feb 9, 2036method-of-use (U-3806)US 11684620
Feb 9, 2036method-of-use (U-3806)US 11684620
Oct 18, 2035method-of-use (U-3972)US 12037644
Oct 18, 2035method-of-use (U-3972)US 12037644
Oct 18, 2035method-of-use (U-3972)US 12037644
Mar 26, 2035formulationUS 9902714
Mar 26, 2035formulationUS 9902714
Mar 26, 2035formulationUS 9902714
Apr 12, 2033compositionUS 8895601
Apr 12, 2033compositionUS 8895601
Apr 12, 2033compositionUS 8895601
Apr 28, 2031method-of-use (U-3805)US 94640714.8y
Apr 28, 2031method-of-use (U-3805)US 94640714.8y
Apr 28, 2031method-of-use (U-3805)US 94640714.8y

FDA exclusivities (3)

Jan 19, 2027I-930Indication (3y)196d
Jan 19, 2027I-930Indication (3y)196d
Jan 19, 2027I-930Indication (3y)196d

🐶 often sniffed alongside

top 4

drugBALVERSA44 co-mentions · 11 sources
tagApproval44 co-mentions · 11 sources
companyJanssen Biotech Inc22 co-mentions · 11 sources
tagSmall Molecule22 co-mentions · 11 sources

Trials studying erdafitinib

phase2An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Canceractive not recruitingn=239
phase1A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Canceractive not recruitingn=5
phase3A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrationsactive not recruitingn=629
phase2Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancerrecruitingn=235
phase2A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Canceractive not recruitingn=125
phase2A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterationsactive not recruitingn=316
phase2A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)completedn=107
phase2Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterationsrecruitingn=90

more trials →