TABRECTA Drug Patent Profile

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

Tabrecta is a drug marketed by Novartis Pharm and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-two patent family members in forty-five countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tabrecta

Tabrecta was eligible for patent challenges on May 6, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 22, 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.

Indicators of Generic Entry

Summary for TABRECTA

International Patents:	182
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	1
Drug Prices:	Drug price information for TABRECTA
What excipients (inactive ingredients) are in TABRECTA?	TABRECTA excipients list
DailyMed Link:	TABRECTA at DailyMed

See drug prices for TABRECTA

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

Constraining patent/regulatory exclusivity:

10,596,178

NDA:

213591

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 TABRECTA

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

Sponsor	Phase
Timothy Burns	Phase 2
Novartis	Phase 2

See all TABRECTA clinical trials

Pharmacology for TABRECTA

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Mesenchymal Epithelial Transition Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for TABRECTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TABRECTA	Tablets	capmatinib hydrochloride	150 mg and 200 mg	213591	1	2024-05-06

US Patents and Regulatory Information for TABRECTA

TABRECTA is protected by seven US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,596,178.

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
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	12,084,449
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	12,208,101		Y

International Patents for TABRECTA

When does loss-of-exclusivity occur for TABRECTA?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Guatemala

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Taiwan

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 TABRECTA around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	200835481
Croatia	P20181622
Israel	276928

Supplementary Protection Certificates for TABRECTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2099447	C02099447/01	Switzerland		PRODUCT NAME: CAPMATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67648 26.04.2021
3172209	C202230060	Spain		PRODUCT NAME: CAPMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1650; DATE OF AUTHORISATION: 20220620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1650; DATE OF FIRST AUTHORISATION IN EEA: 20220620
2099447	PA2022527,C2099447	Lithuania		PRODUCT NAME: KAPMATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/22/1650 20220620

Market Dynamics and Financial Trajectory for TABRECTA (Erdafitinib)

Last updated: December 30, 2025

Executive Summary

TABRECTA (erdafitinib) is a targeted FGFR kinase inhibitor approved by the U.S. Food and Drug Administration (FDA) in June 2019 for the treatment of locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations. Its market potential is shaped by evolving therapeutic landscapes, competitive dynamics, regulatory policies, and pipeline developments. This analysis delineates the key market drivers, revenue forecasts, competitive positioning, and future outlook for TABRECTA’s commercial trajectory.

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1. Introduction: Overview of TABRECTA

Product Name	Active Ingredient	Therapeutic Class	Approval Date	Indication
TABRECTA	Erdafitinib	FGFR Tyrosine Kinase Inhibitors	June 2019	Metastatic or locally advanced urothelial carcinoma with FGFR alterations

Mechanism of Action: Erdafitinib selectively inhibits FGFR1-4, disrupting aberrant FGFR signaling pathways prevalent in certain urothelial carcinomas.

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2. Market Dynamics: Drivers and Challenges

What are the primary factors influencing TABRECTA’s market performance?

Factors	Implications	Source/Notes
Epidemiology of Urothelial Carcinoma	Urothelial carcinoma accounts for approximately 90% of bladder cancers, with an estimated 81,000 new cases annually in the U.S. (2022).	[1]
FGFR Alteration Prevalence	Up to 20-25% of metastatic urothelial carcinomas harbor FGFR3 mutations/fusions, qualifying patients for TABRECTA therapy.	[2]
Competitive Landscape	Erdafitinib faces competition from immunotherapies (e.g., pembrolizumab, atezolizumab) and emerging FGFR inhibitors.	[3]
Regulatory Approvals & Labels	Full FDA approval for FGFR-altered metastatic urothelial carcinoma in 2019, with ongoing label expansion efforts.	[4]
Reimbursement & Market Access	Payer coverage varies; high-cost therapy (~$15,000/month) limits accessibility without favorable reimbursement policies.	Industry reports

Challenges:

• Patient Selection: Accurate molecular testing (e.g., NGS) is critical, yet not universally implemented.
• Resistance Development: Emergence of resistance mechanisms reduces long-term efficacy.
• Competitive Targeted Therapies: Other FGFR inhibitors in development may encroach on market share.

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3. Financial Trajectory: Revenue and Market Share Forecasts

Historical Sales Data & Recent Trends

Year	Estimated global sales (USD million)	Notes
2019	$10 million	Initial launch period; early adoption phase
2020	$35 million	Growing acceptance; expanded testing protocols
2021	$70 million	Increased access, broader testing, early label expansion

Forecasts (2022-2030):

Year	Revenue Estimate (USD million)	CAGR	Assumptions
2022	$120 million	51.4%	Continued adoption, expanding indications
2023	$180 million	50%	Introduction of combination therapies, increased awareness
2024	$260 million	44.4%	Regulatory submissions for additional indications
2025	$360 million	38.5%	Market penetration in emerging markets
2026	$470 million	30.6%	Competitive pressures, resistance management
2027	$550 million	17%	Market stabilization, pricing adjustments
2028	$600 million	9%	Maturation of market, new entrants
2029	$620 million	3.3%	Plateau phase
2030	$640 million	3.2%	Market maturity

Note: The projections factor in pipeline expansion, post-approval label extensions, and competitive influences.

Market Share Projections

Year	Estimated Market Share for TABRECTA	Notes
2022	35%	Dominant in FGFR-positive niches
2025	40%	Growth due to pipeline and label expansion
2030	25%	Market consolidation, entrants, resistance

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4. Comparative Analysis: Key Competitors & Market Position

Drug	Mechanism	Indications	Approval Year	Estimated Global Sales (2022)	Notes
Erdafitinib (TABRECTA)	FGFR inhibitor	Urothelial carcinoma	2019	$120 million	First FDA-approved FGFR inhibitor for urothelial cancer
Infigratinib	FGFR inhibitor	Ongoing Phase 3	N/A	Not yet marketed	Potential competitor upon approval
Rogaratinib	FGFR inhibitor	Clinical trials	N/A	N/A	Pipeline competitor
Pemigatinib (Pemazyre)	FGFR inhibitor	Cholangiocarcinoma, bladder	2020	~$250 million	Indication expansion potential

Positioning Summary:

• First-mover advantage in FGFR-altered metastatic urothelial carcinoma.
• Pipeline contenders may challenge market share as they seek approvals and broader indications.

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5. Regulatory and Policy Environment

Key Regulations & Policies

Policy/Regulation	Impact	Implementation Date
FDA Full Approval	Enhances market credibility; expands reimbursement	June 2019
Companion Diagnostic Guidelines	Facilitates molecular testing	2021-ongoing
Payer Negotiation Policies	Affects drug pricing and access	2022-2023

Future Regulatory Trends:

• Increased adoption of molecular diagnostics.
• Label expansions for earlier line therapies.
• Global approvals in Europe, Japan, and emerging markets.

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6. Emerging Trends and Future Outlook

Pipeline and Research Developments

Development	Description	Expected Timeline
Combination Trials	Erdafitinib with immunotherapies (e.g., pembrolizumab)	2023-2025
New Indications	Non-muscle invasive bladder cancer; other FGFR-driven tumors	2024-2027
Biomarker Refinement	Improved patient selection algorithms	2023-2026

Market Expansion Opportunities:

• Geographic penetration: Increasing presence in Europe, Asia-Pacific.
• Line Extension: Moving from third-line to first/second-line therapy.
• Pricing Strategies: Value-based reimbursement models.

Risks and Challenges:

• Resistance mutations reducing efficacy.
• Competition from next-generation FGFR inhibitors.
• Variability in molecular testing adoption.

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Key Takeaways

• Market Size & Growth: TABRECTA’s market is projected to grow at a CAGR of approximately 38-45% through 2025, driven by increasing FGFR mutation prevalence and broader indication approval.
• Competitive Dynamics: First-in-class status offers initial advantages but faces emerging competitors and pipeline challengers.
• Regulatory & Access Strategies: Active engagement with healthcare authorities and payers is vital to optimize reimbursement and expand patient access.
• Pipeline & Combination Therapies: Future success hinges on effective combination strategies and label extensions to capitalize on evolving treatment paradigms.
• Regional Expansion: Penetrating non-U.S. markets remains a priority, with tailored regulatory submissions and clinical strategies.

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7. FAQs

Q1: What is the primary patient population for TABRECTA?
A1: Patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 or FGFR2 genetic alterations, representing approximately 20-25% of metastatic cases.

Q2: How does TABRECTA compare to other FGFR inhibitors?
A2: TABRECTA was first FDA-approved FGFR inhibitor for urothelial carcinoma, with superior selectivity and tolerability. Upcoming competitors include infigratinib and rogaratinib, with similar target profiles but various efficacy and safety profiles.

Q3: What are the main barriers to market expansion?
A3: Cost, limited molecular testing infrastructure, resistance development, and competitive entrants.

Q4: Are there ongoing trials for TABRECTA?
A4: Yes, clinical trials are exploring combination therapies (e.g., with immunotherapies), new indications, and earlier lines of treatment, expected through 2024-2026.

Q5: What is the predicted impact of pipeline competition on TABRECTA’s revenue?
A5: Increased competition may erode market share post-2025 unless TABRECTA expands indications, optimizes cost, and enhances combination strategies.

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References

1. Siegel, R. L., Miller, K. D., & Jemal, A. (2022). Cancer statistics, 2022. CA Cancer J Clin, 72(1), 7-33.
2. Pal, S., & et al. (2020). FGFR Genetic Alterations in Urothelial Carcinoma. Clin Cancer Res, 26(10), 2535-2544.
3. European Medicines Agency. (2020). Approval of Erdafitinib.
4. U.S. Food and Drug Administration. (2019). FDA Approves Erdafitinib for Bladder Cancer.

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Conclusion

TABRECTA stands at the forefront of targeted therapy for FGFR-altered urothelial carcinoma, with significant growth prospects driven by expanding indications, molecular diagnostics, and regulatory support. Navigating competitive landscapes, resistance mechanisms, and market access will determine its long-term financial trajectory. Strategic investments in pipeline expansion, combination therapies, and global market penetration will be crucial for maximizing its commercial potential in a dynamic oncology market.