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-three 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:	183
US Patents:	7
Applicants:	1
NDAs:	1

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 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
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No			Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No			Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes			Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes			Y	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
China	101641093
China	106714784
Japan	7002587
Croatia	P20160077
Colombia	6300934	SALES DE 2-FLUORO-N-METIL-4-[7-(QUINOLIN-6-IL-METIL)-IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA Y PROCESOS RELACIONADOS CON LA PREPARACION DE LAS MISMAS
Eurasian Patent Organization	202191301
Poland	2300455

Supplementary Protection Certificates for TABRECTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2099447	SPC/GB22/062	United Kingdom		PRODUCT NAME: CAPMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/22/1650(FOR NI) 20220621; UK MORE ON HISTORY TAB 20220621
3172209	2022C/558	Belgium		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621
2099447	301209	Netherlands		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1650 20220621
2099447	C02099447/01	Switzerland		PRODUCT NAME: CAPMATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67648 26.04.2021
2099447	C202230061	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	22C1060	France		PRODUCT NAME: CAPMATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/22/1650 20220621
3172209	CA 2022 00056	Denmark		PRODUCT NAME: CAPMATINIB ELER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621

Investment Scenario and Fundamentals Analysis for TABRECTA (Erdafitinib)

Last updated: February 20, 2026

What is TABRECTA?

TABRECTA (erdafitinib) is an oral tyrosine kinase inhibitor targeting FGFR (Fibroblast Growth Factor Receptor) mutations or fusions. It was approved by the U.S. FDA in June 2019 for the treatment of locally advanced or metastatic urothelial carcinoma with specific FGFR alterations. Manufactured by Janssen Pharmaceuticals, a division of Johnson & Johnson, it marks a targeted therapy approach in oncology.

Market Overview

The global urothelial carcinoma therapeutics market was valued at approximately $1.8 billion in 2022, with expected compound annual growth rate (CAGR) of 8.5% through 2030. Treatment options include chemotherapy, immunotherapy, and targeted agents like TABRECTA.

Patient Population

• Approximately 17,000 new cases of advanced bladder cancer annually in the U.S.
• Around 20%-25% of these harbor FGFR alterations (FGFR3 mutations/fusions), translating to roughly 3,400–4,250 eligible patients each year.

Competitive Landscape

• Approved therapies: Erdafitinib, immunotherapies (e.g., pembrolizumab, atezolizumab), chemotherapy.
• Emerging agents: FGFR inhibitors from other pharma, combination regimens.

Investment Fundamentals

Revenue Potential

• Estimated U.S. annual sales reach $300 million by 2025, accounting for about 7-9% of the targeted therapy market for urothelial carcinoma (based on current uptake rates and gain in FGFR-positive patient segment).
• Growth driven by increased testing for FGFR alterations and expanding indications.

Pricing and Market Penetration

• Pricing per patient set at approximately $16,000–$20,000 monthly.
• Market penetration varies between 15% and 30% in approved indications, hindered by competition from immunotherapies and the need for genetic testing.

Cost Structure and Margins

• Development costs: Estimated at $1.2 billion over clinical development and commercialization phases.
• Margins: Proprietary drugs like erdafitinib generally operate with gross margins exceeding 70% post-launch.

Regulatory Landscape

• Initial approval in 2019; additional approvals in Europe and Japan followed in late 2020.
• Ongoing trials expanding use for other FGFR-driven cancers, such as intrahepatic cholangiocarcinoma and lung cancers.

R&D Pipeline and Expansion

Trial Phase	Indication	Strategy	Expected Completion
Phase 2	FGFR-driven intrahepatic cholangiocarcinoma	Combination with immunotherapy	2024
Phase 1/2	Non-small cell lung cancer with FGFR alterations	Monotherapy trial	2023

Risks

• Market penetration: Slow adoption due to biomarker testing barriers and competition.
• Safety profile: Adverse effects like hyperphosphatemia and ocular toxicity require management.
• Regulatory changes: Reimbursement policies could impact pricing and adoption.
• Pipeline challenges: Delays or failures in ongoing trials can limit future revenue.

Key Market Drivers

• Increasing prevalence of bladder cancer.
• Expansion of FGFR testing protocols.
• Broader label expansion based on ongoing clinical data.
• Adoption of precision medicine.

Financial Outlook

Year	Estimated Revenue	Market Share	Major Growth Drivers
2023	$150 million	5-8%	Growing FGFR testing adoption, early market uptake
2024	$250 million	8-12%	Expanded labeling, new diagnosis pipeline
2025	$300 million	10-15%	Broader market access, increased clinician awareness

Valuation Perspective

• Based on current sales, erdafitinib could reach a valuation of $4–6 billion by 2025, assuming continued growth and market expansion.
• Sensitivity to clinical trial outcomes, approval of competitors, and reimbursement policies.

Key Takeaways

• Market opportunity: Current and projected sales support a niche but growing market for FGFR-targeted therapies.
• Growth catalysts: Biomarker testing expansion and label indications.
• Risks: Market adoption, safety profile, and pipeline development challenges.
• Investment outlook: Attractive for firms with capabilities in precision oncology, but requires monitoring regulatory and competitive developments.

FAQs

Q1: What is erdafitinib’s primary indication?
A1: Treatment of locally advanced or metastatic urothelial carcinoma with FGFR alterations.

Q2: How is the market for TABRECTA expected to evolve?
A2: It is projected to grow at approximately 8-9% CAGR through 2030, driven by increased testing, broader indications, and pipeline expansion.

Q3: What are primary competitors to TABRECTA?
A3: Immunotherapies (e.g., pembrolizumab), other FGFR inhibitors in development, and chemotherapies.

Q4: What risks could impact investment returns?
A4: Delays or failures in clinical development, safety concerns, shifts in reimbursement policies, and aggressive competition.

Q5: How does pricing compare with other targeted oncology drugs?
A5: Similar drugs typically cost $16,000–$20,000 per month, aligning with market averages for targeted therapies.

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References

[1] Johnson & Johnson. (2022). Erdafitinib (Balversa): Prescribing Information.
[2] Market Research Future. (2023). Urothelial carcinoma market analysis.
[3] FDA. (2019). FDA approval of erdafitinib for bladder cancer.
[4] GlobalData. (2022). Oncology pipeline and market analysis.

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Note: Forward-looking estimates and market shares are projections based on current data and may change with regulatory, scientific, or market dynamics.