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 twenty-two 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 March 26, 2035. 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.

There is one tentative approval for the generic drug (erdafitinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for BALVERSA

International Patents:	322
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	8
Patent Applications:	1,084
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
Janssen Research & Development, LLC	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
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes			Y
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

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

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

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Ukraine

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
Argentina	104172
Australia	2016243917
Australia	2022201060
Australia	2025204202
Brazil	112017020973
Canada	2981603
Chile	2017002481

Supplementary Protection Certificates for BALVERSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	PA2025509	Lithuania		PRODUCT NAME: ERDAFITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA JOSOLVATAS; REGISTRATION NO/DATE: EU/1/24/1841 20240822
2563775	C20250009	Finland		PRODUCT NAME: REPOTREKTINIIBUM;REG NO/DATE: EU/1/24/1883 14.01.2025
2563775	CR 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	122025000006	Germany		PRODUCT NAME: ERDAFITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/24/1841 20240822
2563775	LUC00379	Luxembourg		PRODUCT NAME: ERDAFITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU L'UN DE SES SOLVATES; AUTHORISATION NUMBER AND DATE: EU/1/24/1841 20240823

BALVERSA: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

What is BALVERSA and its Regulatory Status?

BALVERSA (erdafitinib) is an orally administered fibroblast growth factor receptor (FGFR) inhibitor developed by Janssen Pharmaceutical Companies of Johnson & Johnson. It targets specific genetic mutations in FGFRs, including FGFR1, FGFR2, FGFR3, and FGFR4.

BALVERSA received accelerated approval from the U.S. Food and Drug Administration (FDA) on April 12, 2019, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has progressed during or after at least one prior line of platinum-based chemotherapy, and who are ineligible for or have progressed after PD-1/PD-L1 inhibitor therapy, and have an identifiable FGFR3 genetic alteration (gene fusion or other rearrangement) as detected by an FDA-approved test [1, 2].

The FDA's accelerated approval pathway allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate endpoint that is reasonably likely to predict clinical benefit. The continued approval of BALVERSA is contingent upon the verification of clinical benefit in confirmatory trials [1].

On January 19, 2021, the European Medicines Agency (EMA) granted conditional marketing authorization for BALVERSA for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations who have progressed following prior platinum-based chemotherapy and treatment with a PD-1/PD-L1 inhibitor [3]. Conditional marketing authorization is granted when the EU public health need is high and a medicinal product offers a major therapeutic innovation, subject to specific follow-up obligations [3].

What is the Target Patient Population and Clinical Efficacy?

The target patient population for BALVERSA includes adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who have specific genetic alterations in FGFR. This includes patients with FGFR3 gene fusions or other rearrangements. Crucially, these patients must have experienced progression of their disease during or after at least one prior line of platinum-based chemotherapy and be ineligible for or have progressed after PD-1/PD-L1 inhibitor therapy [1, 2].

The efficacy of BALVERSA was primarily evaluated in the single-arm, open-label, multi-center Phase 2 study, NCT02365597 (Study 1365) [1, 2]. The primary endpoint for the accelerated approval was objective response rate (ORR) and duration of response (DoR) in patients with FGFR3 gene alterations [1].

Key efficacy findings from Study 1365 included:

• Objective Response Rate (ORR): In patients with documented FGFR3 genetic alterations (fusions or rearrangements) who received BALVERSA, the ORR was 23% (95% CI: 12% to 37%) [1].
• Complete Response (CR): 3% of patients achieved a complete response.
• Partial Response (PR): 20% of patients achieved a partial response.
• Duration of Response (DoR): The median DoR was 8.3 months (95% CI: 5.0 to 12.4) [1].
• Median Progression-Free Survival (PFS): The median PFS was 5.5 months (95% CI: 3.7 to 7.0) [1].
• Median Overall Survival (OS): The median OS was 13.1 months (95% CI: 9.9 to 17.7) [1].

These results demonstrated a clinically meaningful response in a heavily pre-treated patient population with limited treatment options.

What are the Key Safety Concerns and Adverse Events?

The safety profile of BALVERSA has been characterized by a range of adverse events, with serious ocular, metabolic, and skin toxicities being notable [1, 2, 3]. The prescribing information includes a boxed warning regarding ocular and related toxicities, as well as hyperphosphatemia and stomatitis [1].

Key safety concerns and adverse events include:

• Ocular Toxicities: Dry eye, retinal pigment epithelium detachment, visual impairment, and photophobia are significant concerns. These events can be severe and require dose interruption or discontinuation [1].
  • Dry eye occurred in 59% of patients, with 10% experiencing Grade 3 severity.
  • Retinal pigment epithelium detachment (RPED) occurred in 31% of patients, with 5% experiencing Grade 3 or 4 severity.
  • Visual impairment was reported in 42% of patients, with 4% experiencing Grade 3 or 4 severity.
• Hyperphosphatemia: Elevated serum phosphate levels are a common and expected side effect due to FGFR inhibition. Close monitoring of serum phosphate is required [1].
  • Hyperphosphatemia occurred in 74% of patients, with 25% experiencing Grade 3 or 4 severity.
• Stomatitis/Mucositis: Inflammation of the mouth and mucous membranes is frequently observed [1].
  • Stomatitis occurred in 61% of patients, with 13% experiencing Grade 3 severity.
• Other Common Adverse Events (≥20% incidence):
  • Diarrhea (59%)
  • Fatigue (55%)
  • Alopecia (39%)
  • Nail dystrophy (37%)
  • Constipation (35%)
  • Decreased appetite (30%)
  • Dysgeusia (26%)
  • Abdominal pain (22%)
  • Nausea (20%)
• Serious Adverse Events: The most common serious adverse events included urinary tract infection (11%), stomatitis (10%), diarrhea (8%), nausea (4%), vomiting (4%), abdominal pain (3%), cellulitis (3%), acute kidney injury (3%), and dehydration (3%) [1].

Management of these adverse events often requires dose adjustments, supportive care, and ophthalmologist consultation [1, 3].

What is the Competitive Landscape for FGFR Inhibitors in Urothelial Carcinoma?

The competitive landscape for FGFR inhibitors in urothelial carcinoma is evolving, with BALVERSA being a pioneer in this targeted therapy space. However, other FGFR inhibitors are in development and may seek approval for similar indications or in earlier lines of therapy [4].

Key Competitors and Considerations:

• Infigratinib (Tragis™): Developed by QED Therapeutics (a BridgeBio Pharma company), infigratinib is an orally administered FGFR inhibitor. It has received FDA approval for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement [5]. While its primary indication is cholangiocarcinoma, research and clinical trials are exploring its potential in urothelial carcinoma [4].
• Pemigatinib (Pemazyre®): Developed by Incyte Corporation, pemigatinib is another orally administered FGFR1 inhibitor. It gained FDA approval for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or other rearrangement [6]. Similar to infigratinib, its development pipeline includes investigations into other FGFR-altered cancers, potentially including urothelial carcinoma [4].
• Other FGFR Inhibitors: Several other FGFR inhibitors are in various stages of clinical development, targeting different FGFR isoforms or combinations. These include agents like roluatinib and futibatinib. The success of these agents will depend on demonstrating distinct efficacy and safety profiles, and potentially targeting different patient subgroups or earlier treatment lines [4].

Market Dynamics:

• Diagnostic Testing: The efficacy of BALVERSA and other FGFR inhibitors is directly linked to the presence of specific FGFR alterations. Companion diagnostics that accurately detect these genetic mutations are critical for patient identification and treatment selection. The availability and accessibility of these tests are significant market drivers [1, 2].
• Treatment Sequencing: The current indication for BALVERSA is in the third-line setting (after platinum-based chemotherapy and PD-1/PD-L1 inhibitors). Future competition may arise from agents approved for earlier lines of therapy, potentially impacting BALVERSA's market share.
• Combination Therapies: Research is ongoing to evaluate the efficacy of combining FGFR inhibitors with other therapeutic modalities, such as immunotherapy or chemotherapy, to improve treatment outcomes and overcome resistance mechanisms. Success in these combinations could expand the market for FGFR inhibitors [7].

What is the Projected Financial Trajectory and Market Size?

Predicting the precise financial trajectory of BALVERSA involves analyzing current sales, market penetration, pipeline developments, and competitive pressures. As a targeted therapy in a specific subset of urothelial carcinoma patients, its market size is defined by the prevalence of these genetic alterations and the uptake of the drug.

Key Factors Influencing Financial Trajectory:

• Sales Performance: Initial sales figures for BALVERSA have been modest, reflecting its niche indication and the complexities of targeted therapy adoption. For example, in 2022, Janssen (Johnson & Johnson) reported worldwide sales of BALVERSA as $205 million [8]. This represents a growth from $141 million in 2021 [9].
• Market Penetration: The market penetration of BALVERSA is influenced by the prevalence of FGFR alterations in the urothelial carcinoma population. Estimates suggest that FGFR alterations are found in approximately 10-20% of patients with metastatic urothelial carcinoma [10].
• Geographic Expansion: Approval and launch in major markets outside the U.S., such as Europe and potentially Asia, will be crucial for revenue growth. The conditional marketing authorization in Europe is a step towards this expansion.
• Indication Expansion: The primary driver for significant financial growth would be the expansion of BALVERSA's indication into earlier lines of therapy or into broader patient populations, if clinical trials support this. Additionally, exploring its efficacy in other FGFR-altered cancers could open new revenue streams.
• Competition: As noted in the competitive landscape section, the emergence of new FGFR inhibitors or other targeted therapies could impact market share and pricing power.
• Pricing and Reimbursement: The pricing of BALVERSA, coupled with reimbursement policies in different healthcare systems, directly affects its accessibility and revenue potential. The cost-effectiveness of targeted therapies is a key consideration for payers.

Projected Market Size (Estimates):

Forecasting the exact market size for a niche oncology drug is challenging and subject to numerous variables. However, based on available data and market trends for targeted cancer therapies, potential market size can be estimated:

• The global urothelial carcinoma market is substantial, with estimates projecting it to reach billions of dollars in the coming years, driven by an aging population and increased cancer incidence [11].
• The addressable market for FGFR inhibitors within urothelial carcinoma, representing patients with identified FGFR alterations, is a smaller but growing segment. If BALVERSA captures a significant portion of this segment and potentially expands its indications, its annual revenue could reach several hundred million dollars to over a billion dollars in the longer term, contingent on successful clinical development and market access.
• Consensus analyst forecasts for BALVERSA's sales vary, but many project continued year-over-year growth, reflecting increasing awareness, diagnostic capabilities, and potential market expansion [8, 9].

The financial trajectory will be closely watched as further clinical data emerges and as competitive pressures intensify within the targeted therapy landscape for urothelial carcinoma.

Key Takeaways

• BALVERSA is an FGFR inhibitor approved for specific, pre-treated metastatic urothelial carcinoma patients with FGFR3 alterations, offering a targeted treatment option.
• Efficacy demonstrated an objective response rate of 23% in its approved indication, with median DoR of 8.3 months, providing a meaningful clinical benefit for a heavily pre-treated population.
• Significant safety concerns include ocular toxicities, hyperphosphatemia, and stomatitis, requiring vigilant monitoring and management.
• The competitive landscape for FGFR inhibitors in urothelial carcinoma is developing, with other agents like infigratinib and pemigatinib also targeting FGFR alterations, primarily in cholangiocarcinoma, but with potential for urothelial carcinoma indications.
• BALVERSA generated $205 million in worldwide sales in 2022, demonstrating growth in its niche market, with future financial trajectory dependent on market penetration, geographic expansion, and potential indication expansion.

FAQs

1. What are the key genetic alterations in FGFR that BALVERSA targets? BALVERSA targets specific genetic alterations in fibroblast growth factor receptors (FGFRs), including FGFR1, FGFR2, FGFR3, and FGFR4. For its current indication in urothelial carcinoma, the focus is on FGFR3 gene fusions or other rearrangements.

2. How does BALVERSA's mechanism of action differ from traditional chemotherapy in urothelial carcinoma? BALVERSA is a targeted therapy that specifically inhibits the activity of mutated or overactive FGFRs, thereby blocking signaling pathways that promote cancer cell growth and survival. Traditional chemotherapy agents are cytotoxic and affect rapidly dividing cells, both cancerous and healthy, leading to a broader range of side effects.

3. What is the role of companion diagnostics in BALVERSA treatment? Companion diagnostics are essential for identifying patients with the specific FGFR3 genetic alterations required for BALVERSA treatment. An FDA-approved test is mandated to detect these alterations to ensure appropriate patient selection and maximize treatment efficacy.

4. Are there plans to investigate BALVERSA in earlier lines of urothelial carcinoma treatment? While BALVERSA is currently approved for patients who have progressed on prior therapies, ongoing clinical research and development efforts may explore its efficacy in earlier lines of treatment for urothelial carcinoma, potentially expanding its therapeutic utility and market.

5. What are the main challenges for BALVERSA in terms of market access and adoption? Challenges include the need for precise genetic testing for patient identification, management of significant side effects like ocular toxicities and hyperphosphatemia, competition from other targeted therapies, and securing favorable reimbursement and market access across different healthcare systems.

Citations

[1] U.S. Food and Drug Administration. (2019, April 12). FDA approves BALVERSA® (erdafitinib) for adults with metastatic urothelial carcinoma. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-balversa-erdafitinib-adults-metastatic-urothelial-carcinoma

[2] Janssen Pharmaceutical Companies of Johnson & Johnson. (n.d.). BALVERSA® (erdafitinib). Retrieved from https://www.balversa.com/

[3] European Medicines Agency. (2021, January 19). Ema recommends authorisation of balversa for urothelial carcinoma. Retrieved from https://www.ema.europa.eu/en/news/ema-recommends-authorisation-balversa-urothelial-carcinoma

[4] ClinicalTrials.gov. (n.d.). Search results for FGFR inhibitors in urothelial carcinoma. Retrieved from https://clinicaltrials.gov/

[5] QED Therapeutics. (n.d.). Infigratinib (Tragis™). Retrieved from https://www.qedtx.com/infigratinib

[6] Incyte Corporation. (n.d.). Pemazyre® (pemigatinib). Retrieved from https://www.incyte.com/pipeline/pemazyre

[7] Schuler, M. H., et al. (2020). FGFR Inhibitors in Cancer Therapy. Clinical Cancer Research, 26(21), 5570–5582.

[8] Johnson & Johnson. (2023, February 7). Johnson & Johnson Announces 2022 Fourth Quarter and Full Year Results. Retrieved from https://www.jnj.com/media/press-releases/johnson-johnson-announces-2022-fourth-quarter-and-full-year-results

[9] Johnson & Johnson. (2022, February 8). Johnson & Johnson Reports 2021 Fourth-Quarter and Full-Year Results. Retrieved from https://www.jnj.com/media/press-releases/johnson-johnson-reports-2021-fourth-quarter-and-full-year-results

[10] Medical News Today. (2019, April 12). FDA approves new drug for advanced urothelial carcinoma. Retrieved from https://www.medicalnewstoday.com/articles/324956

[11] Grand View Research. (2023). Urothelial Carcinoma Market Size, Share & Trends Analysis Report By Drug Class (Chemotherapy, Targeted Therapy, Immunotherapy), By Indication (Bladder Cancer, Ureter Cancer, Renal Pelvis Cancer), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/urothelial-carcinoma-market

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