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  1. pharmadog
  2. ›drugs
  3. ›Balversa
drug · small molecule
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erdafitinib

Marketedupdated 3mo ago
by $JNJ JOHNSON & JOHNSON🔗 ChEMBL
Approved
community read0 votes

🐶 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

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
Apr 12, 2019
approval
7y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Apr 2, 2020
approval
6y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Apr 27, 2022
approval
4y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Apr 27, 2022
approval
4y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Jan 11, 2023
approval
4y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Mar 20, 2023
approval
3y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Jan 19, 2024
approval
3y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Jan 19, 2024
approval
3y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Jan 19, 2024
approval
3y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Oct 9, 2024
approval
2y ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
Oct 17, 2025
approval
10mo ago
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
→
view all 11 catalysts →

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 →

Patent cliff

source: FDA Orange Book
first barrier falls
Jan 19, 2027
157 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 94640714.7y
  • Apr 28, 2031method-of-use (U-3805)US 94640714.7y
  • Apr 28, 2031method-of-use (U-3805)US 94640714.7y

FDA exclusivities (3)

  • Jan 19, 2027I-930Indication (3y)157d
  • Jan 19, 2027I-930Indication (3y)157d
  • Jan 19, 2027I-930Indication (3y)157d

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
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 34m ago
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