drug · small molecule
erdafitinib
Marketedupdated 5mo agoby $JNJ JOHNSON & JOHNSON🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4Small 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
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Apr 2, 2020
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Apr 27, 2022
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Apr 27, 2022
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Jan 11, 2023
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Mar 20, 2023
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Jan 19, 2024
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Jan 19, 2024
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Jan 19, 2024
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Oct 9, 2024
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Oct 17, 2025
approval
BALVERSA (ERDAFITINIB) — FDA approval
erdafitinib
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Trials studying erdafitinib
- phase2An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer
- phase1A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
- 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 Aberrations
- phase2Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
- phase2A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer
- phase2A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
- 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)
- phase2Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 19, 2027
112 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 94640714.6y
- Apr 28, 2031method-of-use (U-3805)US 94640714.6y
- Apr 28, 2031method-of-use (U-3805)US 94640714.6y
FDA exclusivities (3)
- Jan 19, 2027I-930Indication (3y)112d
- Jan 19, 2027I-930Indication (3y)112d
- Jan 19, 2027I-930Indication (3y)112d
News(2)
- Tyra disappoints investors with bladder cancer dataRemission rates observed in a Phase 2 trial fell short of Wall Street's expectations, though some analysts believe the company should see better results in late-stage testing.biopharma_dive · 19d ago
- Tyra rolls toward pivotal bladder cancer study even as midphase data deflates stockTyra Biosciences has reported initial phase 2 data on dabogratinib in bladder cancer, putting the biotech on course to start a registrational study next year. But the biotech’s stock fell in premar…fiercebiotech · 19d ago
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