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BALVERSA Drug Patent Profile

Which patents cover Balversa, and what generic alternatives are available?

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 two hundred and eighty-three patent family members in forty-eight 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:	283
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	8
Patent Applications:	188
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

Constraining patent/regulatory exclusivity:

10,898,482

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 two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,898,482.

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	9,464,071
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	10,478,494
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	11,684,620
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	8,895,601		Y	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

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
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

BALVERSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BALVERSA (Erdafitinib)

Introduction to BALVERSA

BALVERSA (erdafitinib) is a groundbreaking FGFR kinase inhibitor developed by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson. It has been approved for the treatment of locally advanced or metastatic urothelial carcinoma, particularly in patients with specific fibroblast growth factor receptor (FGFR) alterations.

Regulatory Milestones

Accelerated Approval and Full Approval

BALVERSA received accelerated approval from the FDA in April 2019 based on a small single-arm Phase II trial that demonstrated a 32.2% objective response rate and a median duration of response of 5.4 months[4]. In January 2024, the FDA granted full approval for BALVERSA following the confirmatory Phase 3 THOR study, which showed a significant improvement in overall survival and progression-free survival compared to chemotherapy[4][5].

Clinical Efficacy

Phase 3 THOR Study

The THOR study, which enrolled nearly 630 patients, compared BALVERSA against the standard of care, including chemotherapy or Merck’s Keytruda. The data from Cohort 1 of the THOR study revealed that BALVERSA reduced the risk of death by 36% versus chemotherapy, with patients on BALVERSA living a median of four months longer than those on chemotherapy. This study also showed an improvement in median progression-free survival (PFS) of 5.6 months versus 2.7 months for chemotherapy[1][4][5].

Response Rates and Safety Profile

The Phase 3 THOR study demonstrated an objective response rate (ORR) of 45.6% for BALVERSA, significantly higher than the 11.5% ORR for chemotherapy. However, the treatment was associated with grade three or higher treatment-related adverse events (TRAEs) in 46% of patients, and serious TRAEs in 8.3% of patients[1].

Market Impact

Targeted Therapy in Oncology

BALVERSA is the first and only targeted therapy approved for patients with locally advanced or metastatic urothelial carcinoma and susceptible FGFR alterations. This targeted approach has significantly advanced the treatment landscape for bladder cancer, offering a more precise and effective option for patients with specific genetic alterations[5].

Competitive Landscape

In the oncology market, particularly for bladder cancer treatments, BALVERSA stands out due to its targeted mechanism of action. It competes with other therapies such as checkpoint inhibitors like Keytruda but offers a distinct advantage for patients with FGFR alterations. The full approval and positive clinical data have strengthened its position in the market[4].

Financial Trajectory

Sales Performance

The approval and subsequent market performance of BALVERSA have contributed to Johnson & Johnson's overall pharmaceutical sales. While specific sales figures for BALVERSA are not detailed in the latest financial reports, the drug's impact is reflected in the broader performance of J&J's Innovative Medicine segment. In 2023, this segment saw operational sales growth of 4.2%, which includes contributions from various oncology treatments like BALVERSA[2].

Revenue Projections

Given the full FDA approval and the positive outcomes from the Phase 3 THOR study, BALVERSA is expected to see increased adoption and revenue growth. Johnson & Johnson's financial projections for 2024 indicate continued growth in the pharmaceutical segment, with estimated operational sales ranging from $88.2 billion to $89.0 billion, reflecting the company's confidence in its oncology portfolio, including BALVERSA[2].

Market Authorization and Global Expansion

European Market

In addition to its FDA approval, Janssen has submitted a marketing authorization application to the European Medicines Agency for BALVERSA as a treatment for adult patients with FGFR3-altered, locally advanced unresectable or metastatic urothelial carcinoma. This move is part of the company's strategy to expand the drug's availability globally[5].

Financial Performance of Johnson & Johnson

Quarterly and Annual Results

Johnson & Johnson reported strong financial results for Q4 and full-year 2023, with operational sales growth of 7.2% and adjusted operational sales growth of 5.7%. The company's adjusted net earnings and adjusted EPS also saw significant increases, reflecting the overall health of its pharmaceutical business, which includes the performance of BALVERSA[2].

Key Takeaways

• Regulatory Approval: BALVERSA received full FDA approval in January 2024 following positive results from the Phase 3 THOR study.
• Clinical Efficacy: The drug demonstrated a 36% reduction in the risk of death and improved progression-free survival compared to chemotherapy.
• Market Impact: BALVERSA is a pioneering targeted therapy for bladder cancer, offering a precise treatment option for patients with FGFR alterations.
• Financial Trajectory: The drug is expected to contribute to Johnson & Johnson's growing pharmaceutical sales, with the company projecting continued growth in its oncology segment.
• Global Expansion: BALVERSA is being considered for approval in the European market, further expanding its global reach.

FAQs

What is BALVERSA used for?

BALVERSA (erdafitinib) is used for the treatment of locally advanced or metastatic urothelial carcinoma in patients with specific FGFR genetic alterations.

What were the key findings of the Phase 3 THOR study?

The Phase 3 THOR study showed that BALVERSA reduced the risk of death by 36% compared to chemotherapy and improved median progression-free survival from 2.7 months to 5.6 months.

When did BALVERSA receive full FDA approval?

BALVERSA received full FDA approval in January 2024.

What are the common side effects of BALVERSA?

Common side effects include increased phosphate levels, and grade three or higher treatment-related adverse events were observed in 46% of patients.

How does BALVERSA fit into Johnson & Johnson's financial performance?

BALVERSA contributes to the overall growth of Johnson & Johnson's pharmaceutical segment, which saw operational sales growth of 4.2% in 2023.

Sources

1. Janssen Announces BALVERSA® (erdafitinib) Improved Overall Survival Versus Chemotherapy in Patients - Janssen Pharmaceutical Companies.
2. Johnson & Johnson Reports Q4 and Full-Year 2023 Results - Johnson & Johnson Investor Relations.
3. Summary Basis of Decision for Balversa - Health Canada.
4. J&J Secures Full FDA Approval for Bladder Cancer Drug Balversa - BioSpace.
5. U.S. Food and Drug Administration Grants Full Approval for BALVERSA to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations - PR Newswire.