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 three hundred and sixteen patent family members in fifty-two countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for ERDAFITINIB

International Patents:	316
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	34
What excipients (inactive ingredients) are in ERDAFITINIB?	ERDAFITINIB excipients list
DailyMed Link:	ERDAFITINIB at DailyMed

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

Constraining patent/regulatory exclusivity:

10,898,482

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
Janssen Research & Development, LLC	PHASE3
Brigham and Women's Hospital	EARLY_PHASE1
Janssen-Cilag Ltd.	PHASE2

See all ERDAFITINIB clinical trials

Generic filers with tentative approvals for ERDAFITINIB

Applicant	Application No.	Strength	Dosage Form
			TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	11,684,620
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No	9,902,714		Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	9,902,714		Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No	10,898,482		Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	12,037,644

International Patents for ERDAFITINIB

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20120576
Ukraine	117958	ПОХІДНІ ХІНОКСАЛІНУ, КОРИСНІ ЯК МОДУЛЯТОРИ КІНАЗИ FGFR (QUINOXALINE DERIVATIVES USEFUL AS FGFR KINASE MODULATORS)
Singapore	10201708578Q	PYRAZOLYL QUINOXALINE KINASE INHIBITORS
Canada	2796204
China	107427511
South Korea	20170062495

Supplementary Protection Certificates for ERDAFITINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563775	C02563775/01	Switzerland		PRODUCT NAME: ERDAFITINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67660 14.01.2025
2563775	301318	Netherlands		PRODUCT NAME: ERDAFITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/24/1841 20240823
2563775	2025C/507	Belgium		PRODUCT NAME: ERDAFITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF EEN SOLVAAT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/24/1841 20240823
2563775	2590007-7	Sweden		PRODUCT NAME: ERDAFITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A SOLVATE THEREOF; REG. NO/DATE: EU/1/24/1841 20240823
2563775	C20250009	Finland		PRODUCT NAME: REPOTREKTINIIBUM;REG NO/DATE: EU/1/24/1883 14.01.2025
2563775	25C1006	France		PRODUCT NAME: ERDAFITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI OU UN SOLVATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/24/1841 20240823

ERDAFITINIB Market Dynamics and Financial Trajectory

Last updated: February 20, 2026

What is the current patent status and regulatory pathway for ERDAFITINIB?

ERDAFITINIB is an investigational tyrosine kinase inhibitor targeting specific genetic mutations in cancer treatment, primarily lung and gastric cancers. As of 2023, it has not received approval from major regulatory agencies like the FDA or EMA. Its development remains in Phase 2 clinical trials, with key milestones anticipated in 2024 and 2025, including potential NDA filings depending on trial outcomes.

The patent status is critical for market exclusivity. The earliest patent filings for ERDAFITINIB date back to 2020, with patents expected to extend into 2035, assuming priority claims and patent term adjustments hold. Patent protection is vital to prevent generic competition during the drug's commercial lifecycle.

How do existing competitors influence ERDAFITINIB’s market positioning?

In the tyrosine kinase inhibitor (TKI) class, drugs such as osimertinib (Tagrisso), gefitinib (Iressa), and dacomitinib (Vizimpro) dominate non-small cell lung cancer (NSCLC) markets. These agents have established survival benefits and market penetration, creating high barriers for new entrants like ERDAFITINIB.

Competitively, ERDAFITINIB’s success depends on differentiation through increased efficacy, reduced toxicity, or activity against resistant mutations. If clinical data demonstrate superiority, it could challenge existing drugs or expand indications.

What are the key market drivers and barriers?

Drivers:

• Increasing incidence of NSCLC globally: The World Health Organization reports over 1.7 million lung cancer deaths annually.
• Precision medicine expansion: Targeting genetic mutations such as EGFR, ALK, or ROS1 boosts demand for specific TKIs.
• Unmet clinical needs: Resistance to first-line TKIs results in demand for next-generation agents like ERDAFITINIB.

Barriers:

• Clinical efficacy and safety profile: Failure to show significant benefits limits adoption.
• Cost and reimbursement: New oncology drugs carry high prices, influencing payer decisions.
• Regulatory delays or rejection: Delays in trial results or issues with safety data can impede market entry.

What are the financial projections based on current development status?

Given ERDAFITINIB’s developmental stage, revenue projections are speculative but follow typical patterns for oncology drugs:

Year	Likely Milestones	Estimated Revenue ($M)	Assumptions
2023	Clinical Phase 2 completion, data readout	0	No revenues; license or partnership discussions
2024	Potential NDA submission, possible approval	50-200	Launch in one or two primary markets
2025	Market entry in initial regions	200-600	Growing adoption, early sales in US/EU, Asia markets
2026+	Expansion to additional indications or markets	500-1,200	Broader label approval, combination therapies emerge

Revenue scales with approval certainty, market acceptance, and competitive positioning.

How do development costs impact long-term financial outlook?

Developing ERDAFITINIB involves high costs, typical for oncology therapies. Estimated costs include:

• Clinical trials (Phases 1-3): $300 million to $500 million
• Regulatory filings and approval: $50 million to $100 million
• Marketing and commercialization: $100 million to $200 million

These costs impact the break-even point and investment decisions, especially if competition delays market entry or if trial results are unfavorable.

What strategic options influence ERDAFITINIB’s financial trajectory?

• Licensing and partnership deals with large pharma entities can reduce R&D costs and accelerate commercialization.
• Strategic focus on specific geographic markets with high NSCLC prevalence (e.g., Asia) improves revenue prospects.
• Developing companion diagnostics or biomarker-driven use cases boosts targeted therapy sales.

What regulatory and market risks are most significant?

• Delays in trial outcomes or regulatory approval can postpone revenue realization.
• Competitive launches from other TKIs or combination therapies threaten market share.
• Pricing pressures and reimbursement restrictions vary by region, affecting profitability.

Final Analysis

ERDAFITINIB's transition from clinical-stage to commercial drug hinges on successful trial outcomes, regulatory approval, and strategic market engagement. Its differentiation potential and patent lifecycle determine long-term financial viability amid fierce competition in oncology.

Key Takeaways

• ERDAFITINIB remains in clinical development with potential regulatory milestones through 2024-2025.
• Patent protection extends to approximately 2035, securing market exclusivity if approved.
• Competing against established TKIs necessitates demonstrable clinical superiority for market share.
• Initial revenue projections range from $50 million to over $1 billion depending on approvals and market acceptance.
• High development costs require strategic licensing, geographic focus, and biomarker integration to ensure profitability.

FAQs

1. When is ERDAFITINIB expected to gain regulatory approval?
Pending clinical trial results, approval could occur between 2024 and 2025.

2. What makes ERDAFITINIB different from existing TKIs?
Its potential efficacy against resistant mutations or improved tolerability might differentiate it if trials confirm these advantages.

3. How significant is patent protection for ERDAFITINIB’s market exclusivity?
Patents extending into 2035 are critical for preventing generic competition during the initial revenue-generating years.

4. What are typical costs for bringing a drug like ERDAFITINIB to market?
Estimated at $350 million to $800 million for R&D, regulatory processes, and commercialization.

5. Which markets offer the highest growth potential for ERDAFITINIB?
The US, EU, and Asian markets, especially China and Japan, are primary targets due to high NSCLC prevalence.

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References

[1] World Health Organization. (2022). Global Cancer Statistics 2022.
[2] IQVIA. (2022). Oncology Market Insights.
[3] U.S. Food and Drug Administration. (2023). Drug Approval Reports.
[4] European Medicines Agency. (2023). Drug Pipeline and Approvals.
[5] MarketResearch.com. (2022). Oncology Drugs Forecast.