ERDAFITINIB - Generic Drug Details

What are the generic drug sources for erdafitinib and what is the scope of patent protection?

Erdafitinib is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Erdafitinib has two hundred and eighty-three patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for ERDAFITINIB

International Patents:	283
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	27
Patent Applications:	672
What excipients (inactive ingredients) are in ERDAFITINIB?	ERDAFITINIB excipients list
DailyMed Link:	ERDAFITINIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERDAFITINIB

Dosage:

TABLET;ORAL

^*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.

Recent Clinical Trials for ERDAFITINIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Memorial Sloan Kettering Cancer Center	Phase 2
M.D. Anderson Cancer Center	Phase 2
University of Washington	Phase 2

See all ERDAFITINIB clinical trials

Pharmacology for ERDAFITINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Fibroblast Growth Factor Receptor Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ERDAFITINIB

L01EN	Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ERDAFITINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALVERSA	Tablets	erdafitinib	3 mg, 4 mg and 5 mg	212018	1	2023-04-12

US Patents and Regulatory Information for ERDAFITINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes			Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No			Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes

International Patents for ERDAFITINIB

Country	Patent Number	Title	Estimated Expiration
Colombia	2017011197	Terapia de combinación fgfr/pd-1 para el tratamiento del cancer
Australia	2017202512	PYRAZOLYL QUINOXALINE KINASE INHIBITORS
Canada	3049737	TRAITEMENT DU CANCER (CANCER TREATMENT)
Singapore	10202100562R	FGFR/PD-1 COMBINATION THERAPY FOR THE TREATMENT OF CANCER
Eurasian Patent Organization	028599	ПИРАЗОЛИЛХИНОКСАЛИНОВЫЕ ИНГИБИТОРЫ КИНАЗЫ (PYRAZOLYL QUINOXALINE KINASE INHIBITORS)
Taiwan	201619609	Use of FGFR mutant gene panels in identifying cancer patients that will be responsive to treatment with an FGFR inhibitor
Portugal	3178818

ERDAFITINIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Erdafitinib

Introduction to Erdafitinib

Erdafitinib, a small-molecule, pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, has been making significant waves in the oncology market, particularly in the treatment of urothelial cancer. Here, we delve into the market dynamics and financial trajectory of this promising drug.

Regulatory Approvals and Milestones

Erdafitinib was first granted accelerated approval by the US Food and Drug Administration (FDA) in 2019 for the treatment of patients with locally advanced or metastatic urothelial cancer with FGFR2 or FGFR3 gene mutations or fusions[1].

In January 2024, erdafitinib received full FDA approval for the second-line treatment of FGFR3-altered advanced urothelial cancer, following a statistically significant improvement in overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) in the phase III THOR trial[2].

Clinical Efficacy and Impact

The clinical efficacy of erdafitinib has been robust, with significant improvements in key metrics:

• Objective Response Rate (ORR): Single-agent erdafitinib has shown an ORR of around 45%, while the combination with cetrelimab has achieved an ORR of approximately 55%[4].
• Progression-Free Survival (PFS): Median PFS with single-agent erdafitinib is about 5.5 months, and with the combination, it extends to around 11 months[4].
• Overall Survival (OS): Median OS for erdafitinib alone is around 16 months, and with the combination, it increases to about 20.8 months[4].

These results underscore the drug's potential in improving patient outcomes, particularly in a disease area with high unmet need.

Market Potential and Competition

Urothelial Cancer Market

Urothelial cancer, particularly in its advanced stages, presents a significant market opportunity. Europe has one of the highest rates of bladder cancer, making it a key region for erdafitinib's market potential[3].

Competitive Landscape

Erdafitinib is part of a growing class of FGFR inhibitors, but its approval and clinical data position it favorably:

• First-to-Market Advantage: Erdafitinib was the first FGFR-targeting drug approved by the FDA, giving it a first-mover advantage in this therapeutic space[1].
• Combination Therapies: The drug's efficacy in combination with other agents, such as cetrelimab, further enhances its market appeal and expands its treatment options[4].

Financial Projections and Revenue

Revenue Growth

The full FDA approval and positive clinical trial results are expected to drive significant revenue growth for erdafitinib:

• Market Expansion: With approvals in key regions, including the potential approval in Europe following the submission to the European Medicines Agency (EMA), erdafitinib is poised to capture a substantial share of the urothelial cancer treatment market[3].
• Pricing Strategy: As a targeted therapy with strong clinical evidence, erdafitinib is likely to be priced competitively with other oncology drugs, ensuring a robust revenue stream.

Cost-Benefit Analysis

The cost-benefit analysis of erdafitinib is favorable due to its impact on patient outcomes and healthcare resource utilization:

• Improved Survival Rates: The drug's ability to extend OS and PFS reduces the need for subsequent lines of therapy, potentially lowering overall healthcare costs[4].
• Quality of Life: By providing durable responses and slowing tumor growth, erdafitinib improves the quality of life for patients, which can also have economic benefits in terms of reduced hospitalization and palliative care costs.

Biomarker Testing and Market Impact

Need for Biomarker Testing

The success of erdafitinib highlights the importance of biomarker testing for FGFR alterations in all patients with metastatic urothelial cancer. This necessity can drive additional revenue through diagnostic testing and ensure that patients receive the most appropriate treatment[3].

Market Penetration

Biomarker testing will facilitate higher market penetration for erdafitinib by identifying eligible patients more accurately. This targeted approach ensures that the drug is used in patients who are most likely to benefit, thereby optimizing its market potential.

Industry Expert Insights

Industry experts emphasize the significance of erdafitinib in the treatment landscape:

• Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC: "Erdafitinib has demonstrated promising results in advanced, FGFR-altered UC, making this submission a vital step towards improving outcomes for patients in the future."[3]

Future Trials and Expansions

Ongoing and Planned Trials

Erdafitinib is being evaluated in various ongoing and planned trials, including the RAGNAR trial, a tumor-agnostic study. These trials aim to expand the drug's indications and further solidify its position in the market[4].

Potential in Other Cancers

Research is also exploring erdafitinib's efficacy in other types of cancer, such as non-small cell lung cancer (NSCLC), which could significantly broaden its market reach[5].

Key Takeaways

• Regulatory Approvals: Erdafitinib has received accelerated and full FDA approvals, with pending approval in Europe.
• Clinical Efficacy: The drug has shown strong ORR, PFS, and OS in clinical trials.
• Market Potential: It has a significant market opportunity in urothelial cancer and potential expansions into other cancers.
• Biomarker Testing: The need for biomarker testing for FGFR alterations is crucial for optimal use.
• Financial Projections: Expected revenue growth driven by market expansion, competitive positioning, and cost-benefit analysis.

FAQs

Q: What is erdafitinib used for?

Erdafitinib is used for the treatment of patients with locally advanced or metastatic urothelial cancer with FGFR2 or FGFR3 gene mutations or fusions.

Q: What are the key clinical trial results for erdafitinib?

Erdafitinib has shown an ORR of around 45% as a single agent and 55% in combination with cetrelimab, with median PFS of 5.5 months and median OS of 16 months as a single agent, and 11 months and 20.8 months, respectively, in combination[4].

Q: Is erdafitinib approved in Europe?

Erdafitinib is pending approval in Europe following a submission to the European Medicines Agency (EMA)[3].

Q: What is the role of biomarker testing in the use of erdafitinib?

Biomarker testing for FGFR alterations is crucial to identify patients who are most likely to benefit from erdafitinib, ensuring optimal use and market penetration[3].

Q: Are there ongoing trials to expand erdafitinib's indications?

Yes, erdafitinib is being evaluated in various ongoing and planned trials, including the RAGNAR trial, to expand its indications and further solidify its market position[4].

Sources

1. JAMA Network Open: "Percentage of Patients With FGFR Alterations Eligible for Off-label Use of Erdafitinib to Treat Advanced Cancer With Fibroblast Growth Factor Receptor Alterations"
2. Oxford Academic: "Durable benefit and slowdown in tumor growth dynamics with erdafitinib in FGFR-altered advanced urothelial cancer"
3. Janssen Pharmaceutical Companies of Johnson & Johnson: "Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations"
4. Targeted Oncology: "Erdafitinib's 'Time to Shine' in FGFR-Altered Urothelial Cancer"
5. Annals of Oncology: "FIND: A phase II study to evaluate the efficacy of erdafitinib in FGFR-altered NSCLC"