BALVERSA Drug Patent Profile

Which patents cover Balversa, and when can generic versions of Balversa launch?

Balversa is a drug marketed by Janssen Biotech and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and fifteen patent family members in fifty-two countries.

The generic ingredient in BALVERSA is erdafitinib. One supplier is listed for this compound. Additional details are available on the erdafitinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Balversa

Balversa was eligible for patent challenges on April 12, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 9, 2036. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for BALVERSA

International Patents:	315
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	8
Patent Applications:	1,255
Drug Prices:	Drug price information for BALVERSA
What excipients (inactive ingredients) are in BALVERSA?	BALVERSA excipients list
DailyMed Link:	BALVERSA at DailyMed

See drug prices for BALVERSA

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

NDA:

212018

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 BALVERSA

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1
M.D. Anderson Cancer Center	Phase 2
University of Washington	Phase 2

See all BALVERSA clinical trials

Pharmacology for BALVERSA

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

Paragraph IV (Patent) Challenges for BALVERSA

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 BALVERSA

BALVERSA is protected by seventeen US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No			Y

International Patents for BALVERSA

When does loss-of-exclusivity occur for BALVERSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BALVERSA around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2012003048	Compuestos derivados de n-fenil-3-(1h-pirazol-4-il)quinoxalin-6-amina, inhibidores de tirosino quinasa fgfr; proceso de preparación; composición farmacéutica; y su uso en la prevención o tratamiento de cáncer.
South Korea	20180093134	피라졸릴 퀴녹살린 키나제 억제제 (PYRAZOLYL QUINOXALINE KINASE INHIBITORS)
Croatia	P20191224

Supplementary Protection Certificates for BALVERSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563775	122025000006	Germany		PRODUCT NAME: ERDAFITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/24/1841 20240822
2563775	CA 2025 00006	Denmark		PRODUCT NAME: ERDAFITINIB ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF ELLER ET SOLVAT DERAF; REG. 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

Market Dynamics and Financial Trajectory for BALVERSA

Last updated: August 21, 2025

Introduction

BALVERSA (erdafitinib) is a targeted oral kinase inhibitor developed by Janssen Pharmaceuticals for the treatment of locally advanced or metastatic urothelial carcinoma harboring specific FGFR mutations or fusions. Since its launch, BALVERSA has marked a significant milestone in precision oncology, serving as a pivotal therapy in FGFR-altered bladder cancer. This article provides an in-depth analysis of the market dynamics and financial trajectory shaping BALVERSA's position within the evolving landscape of targeted cancer therapies.

Market Landscape of FGFR-Targeted Oncology

Growing Prevalence of FGFR Alterations in Urothelial Carcinoma

FGFR gene alterations, particularly FGFR3 mutations and fusions, are present in approximately 15-20% of urothelial carcinoma cases, making them a significant biomarker for targeted therapy [1]. The rising incidence of bladder cancer worldwide—estimated at over 573,000 new cases annually—correlates with increasing opportunities for FGFR-targeted agents like BALVERSA [2].

Competitive Environment and Treatment Paradigms

BALVERSA entered a market where immunotherapies such as pembrolizumab and atezolizumab had gained prominence, especially for second-line treatment of advanced bladder cancer. However, FGFR inhibition offers a mechanistically distinct approach, addressing a subset of patients with FGFR alterations resistant to or ineligible for immunotherapy.

Eli Lilly's infigratinib and other FGFR inhibitors like erdafitinib's competitors are under clinical development, intensifying market competition. Nevertheless, BALVERSA’s FDA approval as a first-line targeted therapy for eligible FGFR-altered patients distinguishes its position.

Regulatory Approvals and Reimbursement Policies

Since FDA approval in April 2020, BALVERSA has received regulatory recognition in several other jurisdictions, including the European Union and Japan. Reimbursement negotiations are ongoing, with payers increasingly favoring precision medicines that demonstrate clear benefit in biomarker-selected populations. The inclusion of BALVERSA in treatment guidelines enhances its market penetration prospects.

Financial Trajectory of BALVERSA

Revenue Growth and Sales Performance

Initial sales figures for BALVERSA were modest, constrained by its niche patient population and the relatively slow adoption of biomarker testing. However, as awareness of FGFR alterations grows and diagnostic testing becomes more routine, sales are projected to accelerate.

In 2022, estimates indicated global sales exceeding $150 million, representing a significant growth trajectory compared to its launch year. Analysts anticipate compound annual growth rates (CAGR) in the range of 20-25% over the next five years, driven by increased patient eligibility, expanded indications, and higher testing rates.

Market Penetration Strategies

Janssen’s commercialization efforts emphasize expanding diagnostic testing infrastructure, particularly in regions with high bladder cancer prevalence such as North America and Europe. Partnerships with diagnostic companies facilitate comprehensive FGFR mutation screening, enabling more patients to access BALVERSA earlier in treatment lines.

Clinical trial data showcasing efficacy and safety enhances marketing strategies, fostering physician adoption. The ongoing development of combination regimens with immunotherapy agents also opens new revenue avenues.

Pricing Strategies and Reimbursement Dynamics

BALVERSA’s pricing reflects its targeted nature and the high cost associated with precision oncology drugs. In the U.S., the wholesale acquisition cost (WAC) has been set at approximately $34,000 per month per patient [3].

Reimbursement success is critical; coverage decisions by Medicare and private payers impact net sales. Value-based pricing models are being explored, linking reimbursement levels to clinical outcomes, which could influence its financial landscape.

Key Drivers and Constraints

Drivers

• Increased Diagnostic Adoption: The proliferation of companion diagnostics accelerates patient identification for BALVERSA therapy.
• Regulatory Approvals: Expanding approvals and label extensions increase eligible patient populations.
• Real-World Evidence (RWE): Emerging RWE supports efficacy and safety, fostering clinician confidence and utilization.
• Pipeline Developments: Ongoing trials with combination therapies and first-line approvals broaden indications and sales potential.

Constraints

• Limited Patient Population: Only patients with FGFR alterations qualify, restricting market size.
• Diagnostic Barriers: Limited access to comprehensive FGFR testing hampers eligibility expansion in certain regions.
• Competitive Landscape: The emergence of new FGFR inhibitors and alternative targeted therapies threaten market share.
• Pricing and Reimbursement Challenges: Payer resistance to high-cost targeted therapies may impede revenue growth.

Future Outlook and Financial Prospects

Market Expansion Opportunities

Forecasts project the FGFR inhibitor market to reach over $1 billion globally by 2027, with BALVERSA poised to capture a significant share [4]. Expansion into first-line settings, particularly as combination therapies with immune checkpoint inhibitors prove efficacy, could further elevate sales.

Strategic Initiatives

Janssen’s strategic focus on biomarker-driven clinical development and partnership with diagnostic firms enhances its market position. The integration of real-world data and health economics evidence may facilitate broader payer acceptance.

Risks and Uncertainties

Price regulation pressures, slower-than-expected diagnostic adoption, and intense competition pose risks. Additionally, unforeseen safety signals or lack of durable responses could impact long-term financial performance.

Key Takeaways

• Market Position: BALVERSA is a pioneering FGFR inhibitor with a niche but expanding market in FGFR-altered urothelial carcinoma.
• Growth Drivers: Increased diagnostic testing, regulatory approvals, and development of combination regimens underpin its growth trajectory.
• Financial Outlook: Sales are expected to grow at a robust CAGR, buoyed by broader indications and geographic expansion, though constrained by market size and competition.
• Strategic Priorities: Expanding patient access through diagnostics and evidence generation remains crucial to maximizing financial potential.
• Challenges: Market penetration remains contingent on payer support, diagnostic infrastructure, and competitive innovations.

FAQs

Q1: What distinguishes BALVERSA from other FGFR inhibitors?
A: BALVERSA (erdafitinib) was the first FGFR inhibitor approved specifically for FGFR-altered urothelial carcinoma, with a well-characterized safety profile and demonstrated efficacy in pivotal clinical trials that led to its regulatory approval.

Q2: How does biomarker testing influence BALVERSA's market growth?
A: FGFR mutation testing is essential for identifying eligible patients. Enhanced testing infrastructure and guideline recommendations are critical to expanding the patient pool and driving sales.

Q3: What are the main competitors to BALVERSA?
A: Inhibition of FGFR with other agents like infigratinib and rogertinib are competing options, with ongoing clinical trials aiming to establish comparative efficacy. However, BALVERSA’s regulatory approval and label position give it an initial advantage.

Q4: What is the projected revenue growth for BALVERSA?
A: Industry analysts forecast a CAGR of approximately 20-25% over the next five years, with revenues potentially surpassing $300 million by 2027, driven by indications expansion and increased diagnostic testing.

Q5: How might upcoming combination therapies impact BALVERSA’s financial outlook?
A: Positive results from trials combining BALVERSA with immune checkpoint inhibitors or chemotherapy could extend its label and reinforce its role in first-line therapy, significantly boosting sales.

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References

[1] Cappellen, D., et al. (2019). FGFR alterations in bladder cancer: Diagnostic and therapeutic implications. Oncology Reports.
[2] Globocan. (2022). Estimated global cancer incidence.
[3] Janssen Pharmaceuticals. (2022). BALVERSA (erdafitinib) pricing and reimbursement information.
[4] MarketsandMarkets. (2022). FGFR inhibitor market forecast.