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 fifteen patent family members in fifty-two countries.

One supplier is listed for this compound.

Summary for ERDAFITINIB

International Patents:	315
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
Pivotal S.L.	PHASE2

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	212018-001	Apr 12, 2019		RX	Yes	No	11,077,106
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	12,037,644
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	9,902,714		Y
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	11,684,620
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No	9,464,071
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes	10,478,494

International Patents for ERDAFITINIB

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
Serbia	64778
Cyprus	1124432
Lithuania	3590934

Supplementary Protection Certificates for ERDAFITINIB

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
2563775	PA2025509	Lithuania		PRODUCT NAME: ERDAFITINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA JOSOLVATAS; REGISTRATION NO/DATE: EU/1/24/1841 20240822
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	C20250009	Finland		PRODUCT NAME: REPOTREKTINIIBUM;REG NO/DATE: EU/1/24/1883 14.01.2025

Market Dynamics and Financial Trajectory for Erdafitinib

Last updated: July 29, 2025

Introduction

Erdafitinib (brand name Balversa), developed by Janssen Pharmaceuticals, represents a significant advancement in targeted oncology therapies, specifically within the treatment of metastatic or unresectable urothelial carcinoma harboring FGFR (fibroblast growth factor receptor) genetic alterations. Since its FDA approval in April 2019, erdafitinib's market trajectory offers insight into evolving pharmaceutical landscapes, regulatory pathways, and strategic commercial expansion. This analysis explores the market dynamics fueling erdafitinib's growth, its financial trajectory, and long-term prospects.

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Market landscape and therapeutic significance

Erdafitinib marks a pivotal shift from traditional chemotherapy toward molecularly targeted therapies in urothelial carcinoma (UC). The drug's mechanism involves potent inhibition of FGFR1–4, a pathway aberrantly activated in approximately 20–25% of UC cases, correlating with aggressive disease and poorer prognosis [1]. The targeted nature of erdafitinib has positioned it favorably among oncologists, particularly for patients who have exhausted standard treatments.

The U.S. FDA’s accelerated approval was significant, enabling rapid market entry based on promising early-phase data. This regulatory approach has accelerated access for patients and established erdafitinib as a preferred option within its niche. However, competition remains limited; currently, erdafitinib is the only FDA-approved FGFR inhibitor for UC, though other agents like infigratinib and pemigatinib are in development or seeking approvals.

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Market drivers

1. **High Unmet Medical Need: Refractory UC patients with FGFR alterations lack sufficient effective therapies, creating urgent demand. Erdafitinib fills this gap, leading to swift adoption.

2. **Regulatory Support and Reimbursement: Early approval and positive reimbursement pathways in developed markets have facilitated commercial onboarding. Payer acceptance is bolstered by its targeted profile and biomarker-driven indication, aligning with value-based care models.

3. **Increased Diagnostic Testing: Companion diagnostics, like the FGFR2/3 mutation tests, have seen increased adoption, ensuring that eligible patients are accurately identified. Precision medicine integration sustains erdafitinib's growth potential.

4. **Expanding Indications: Janssen is exploring erdafitinib in broader applications—potentially earlier lines of therapy and other FGFR-driven cancers—expanding the drug’s market universe.

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Market challenges

• Adverse events and tolerability: Known side effects, such as hyperphosphatemia, ocular toxicity, and stomatitis, necessitate careful management, potentially limiting widespread use.

• Resistance mechanisms: Tumor resistance to FGFR inhibition can limit long-term efficacy, with ongoing research needed to design combination regimens or next-generation inhibitors.

• Competitive landscape: Although currently unique, forthcoming FGFR inhibitors and broader pipeline competition could dilute market share.

• Pricing pressures and reimbursement hurdles: As with many precision medicines, high pricing is balanced against payer scrutiny, especially in markets with cost containment mandates.

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Financial trajectory: Revenue streams and projections

Since its pivotal approval, erdafitinib's revenue trajectory reflects initial market penetration followed by steady growth driven by demand and expanded indications.

Initial Launch Performance

In 2019, erdafitinib's sales were modest, estimated at approximately $50 million globally, primarily driven by the U.S. market. Growth was conservative due to limited awareness and the novel nature of the drug, combined with early-stage uptake hurdles.

Growth Drivers and Market Expansion

Between 2020 and 2022, sales escalated as more clinicians adopted the drug following positive real-world evidence and guideline incorporation. In 2022, global sales approached $200 million, with the U.S. accounting for over 70% of revenues. Regulatory submissions for additional indications, such as earlier-line therapy, could enhance future sales streams.

Forecasting Future Revenue

Analyst estimates project that erdafitinib could achieve $500 million to $1 billion annually within five years if expansion strategies succeed and resistance issues are managed (source: EvaluatePharma). Growth acceleration depends on:

• Label expansion: FDA and EMA approvals for broader indications could increase eligible patient populations.

• Market penetration and physician acceptance: Greater awareness and standardized testing protocols are critical.

• Pipeline developments: Combination therapies with immunotherapies or chemotherapies could boost sales volume and duration of treatment.

Pricing Considerations

Pricing strategies are pivotal; in the U.S., erdafitinib is priced around $17,000 per month, aligning with other targeted agents. Payer negotiations and value-based agreements will influence actual revenue realization.

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Strategic opportunities and risks

Janssen’s focus on clinical trials exploring combination regimens, such as with immunotherapies, holds promise for expanding indications and improving outcomes. Conversely, emerging competitors, resistance development, and safety profile management remain risks that could temper growth.

Conclusion: Long-term outlook

Erdafitinib's financial trajectory is poised for substantial growth given its unique position as the first FGFR inhibitor approved for UC. Market expansion, combination strategies, and diagnostic integration could propel revenues toward the billion-dollar mark. Nevertheless, long-term success depends on effective management of resistance, adverse events, and competitive pressures.

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Key Takeaways

• Erdafitinib filled a critical gap in FGFR-driven urothelial carcinoma treatment, driving initial rapid uptake and promising revenue growth.

• Expanding indications, improved diagnostic adoption, and combination therapy trials are vital growth catalysts.

• Market challenges include safety management, resistance, and competitive entries which require strategic navigation.

• Revenue projections suggest substantial growth potential, with strategic expansion and clinical advancements being central to maximizing financial returns.

• Payer and healthcare system acceptance, alongside regulatory approvals for new indications, will shape erdafitinib’s long-term financial trajectory.

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FAQs

1. What is the primary therapeutic indication for erdafitinib?
Erdafitinib is approved for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 genetic alterations in patients who have progressed on platinum-based chemotherapy or with disease unsuitable for cisplatin-containing chemotherapy.

2. How does erdafitinib’s mechanism differ from traditional chemotherapy?
Erdafitinib selectively inhibits FGFR1–4 tyrosine kinases, targeting specific genetic alterations driving tumor growth, unlike chemotherapy which nonspecifically targets rapidly dividing cells.

3. What are the main safety concerns associated with erdafitinib?
Significant adverse effects include hyperphosphatemia, ocular toxicity (such as central serous-like chorioretinopathy), and stomatitis. Monitoring and management protocols are essential during treatment.

4. How does diagnostic testing influence erdafitinib’s market growth?
Companion diagnostics for FGFR mutations facilitate precise patient selection, improving treatment efficacy and expanding the eligible patient population, thereby boosting sales.

5. What are the prospects for erdafitinib beyond urothelial carcinoma?
Research is ongoing into its use for other FGFR-driven cancers, including cholangiocarcinoma and squamous cell lung carcinoma, potentially broadening its therapeutic footprint and market potential.

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Sources

[1] U.S. Food & Drug Administration. “FDA approves Janssen’s Balversa for bladder cancer with FGFR genetic alterations.” 2019.