Erdafitinib Patent Expiration

Erdafitinib is Used for treating locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations that has progressed after prior systemic therapy. It was first introduced by Janssen Biotech Inc in its drug Balversa on Apr 12, 2019.


Erdafitinib Patents

Given below is the list of patents protecting Erdafitinib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Balversa US11077106 Cancer treatment Feb 02, 2038 Janssen Biotech
Balversa US10478494 FGFR/PD-1 combination therapy for the treatment of cancer Aug 13, 2036 Janssen Biotech
Balversa US12678498 Fgfr/Pd-1 Combination Therapy For The Treatment Of Cancer Jun 13, 2036 Janssen Biotech
Balversa US10898482 Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine Feb 09, 2036 Janssen Biotech
Balversa US11684620 Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N′-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine Feb 09, 2036 Janssen Biotech
Balversa US12037644 Use of FGFR mutant gene panels in identifying cancer patients that will be responsive to treatment with an FGFR inhibitor Oct 18, 2035 Janssen Biotech
Balversa US9902714 Quinoxaline derivatives useful as FGFR kinase modulators Mar 26, 2035 Janssen Biotech
Balversa US8895601 Pyrazolyl quinoxaline kinase inhibitors Apr 12, 2033 Janssen Biotech
Balversa US9464071 Pyrazolyl quinoxaline kinase inhibitors Apr 28, 2031 Janssen Biotech



Erdafitinib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Erdafitinib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations Janssen Research & Development, LLC NA COMPLETED
(Aug 1, 2026)
PHASE2
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer Janssen Pharmaceutical K.K. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2


Erdafitinib Generic API Manufacturers

Given below is the list of companies who have filed for Erdafitinib generic, along with the locations of their manufacturing plants worldwide.