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
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 one FDA Regulatory Exclusivity.

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	213591-001	May 6, 2020		RX	Yes	No	12,208,101		Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	10,596,178		Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	7,767,675		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

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
Argentina	111428
Philippines	12017500121	TABLET FORMULATION OF A C-MET INHIBITOR
World Intellectual Property Organization (WIPO)	2008064157
Spain	2857523
Croatia	P20181622
Brazil	PI0719333

Supplementary Protection Certificates for TABRECTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3172209	SPC/GB22/061	United Kingdom		PRODUCT NAME: CAPMATINIB DIHYDROCHLORIDE SALT; REGISTERED: UK EU/1/22/1650(FOR NI) 20220621; UK MORE ON HISTORY TAB 20220621
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
3172209	122022000076	Germany		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
2099447	C02099447/01	Switzerland		PRODUCT NAME: CAPMATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67648 26.04.2021
3172209	51/2022	Austria		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
2099447	122022000083	Germany		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620

Market Dynamics and Financial Trajectory of TABRECTA

Last updated: February 20, 2026

What is the current market position of TABRECTA?

TABRECTA (capmatinib) is a targeted therapy approved for metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations. Approved by the FDA in May 2020, it is marketed by Novartis. The drug's market penetration remains concentrated in US oncological treatment protocols and select European markets.

Market Size and Revenue

• In 2022, Novartis reported TABRECTA revenues of approximately USD 150 million, driven by its expanding use in NSCLC.
• Estimated global target patient population comprises roughly 5,000 new cases annually in the US and similar figures in Europe and Japan.
• The drug's average treatment cost ranges between USD 15,000 and USD 20,000 per patient per month, depending on the region.

Market Penetration & Competition

• Novartis maintains a dominant position, with around 60% of prescribed therapies for MET exon 14 skipping mutations in the US.
• Competitors include Tepmetko (tepotinib) by Ymabs and Savın (savatinib) by Eli Lilly, both targeting similar genetic profiles.
• The inclusion of TABRECTA in NCCN guidelines in 2021 significantly impacted market uptake.

How is the market evolving?

Regulatory and Reimbursement Trends

• The European Medicines Agency (EMA) approved TABRECTA in late 2021, expanding its reach.
• Insurance coverage varies; reimbursement rates are higher in the US (around 85%) versus Europe (approx. 70%), influencing market access and uptake.

Clinical Practices and Off-Label Use

• Physicians increasingly prescribe TABRECTA off-label for MET amplifications outside NSCLC, though evidence remains limited.
• Ongoing clinical trials explore its application in other solid tumors, potentially broadening its use.

New Entrants and Pipeline Developments

• Several pipeline drugs target MET alterations, including Merck's MK-1775 and Pfizer's emerging MET inhibitors.
• The upcoming approval of alternative therapies may exert downward pressure on TABRECTA's market share over next five years.

What are the financial forecasts?

Year	Projected Revenue (USD million)	Assumptions
2023	180	Increased adoption in US and Europe; stable pricing
2024	220	Broader inclusion in treatment guidelines; expanded indications
2025	260	Off-label use increases; pipeline approvals positive
2026	300	Market saturation; competitive pressures moderate

Revenue Drivers

• Growing awareness and physician adoption.
• Broader guideline inclusion and reimbursement coverage.
• Expansion into Asian markets following regulatory approval.

Revenue Risks

• Entry of generic or biosimilar MET inhibitors.
• Regulatory delays in key markets.
• Price pressures due to competitive therapies.

What are the key factors influencing market and financial outcomes?

• Regulatory approvals: Timely approvals in Europe and Asia accelerate growth.
• Reimbursement policies: Higher reimbursement enhances adoption.
• Clinical trial results: Positive data can expand indications; negative results may hinder growth.
• Competitive landscape: New drugs targeting MET alterations can dilute market share.
• Pricing strategy: Maintaining favorable pricing may secure revenue in face of competition.

Closing Summary

TABRECTA retains a strong position in the NSCLC targeted therapy landscape, with revenues projected to increase through 2026 amid expanding indications and geographic reach. Competitive pressure and regulatory developments are key factors influencing its financial trajectory.

Key Takeaways

• Revenue is expected to grow from USD 150 million in 2022 to USD 300 million by 2026.
• Market expansion depends heavily on regulatory approval in Europe and Asia.
• Competition from other MET inhibitors poses a significant threat.
• Reimbursement and clinical guideline adoption directly influence market penetration.
• Pipeline development and new clinical data will shape future growth prospects.

FAQs

1. What is the primary indication for TABRECTA?
Metastatic non-small cell lung cancer with MET exon 14 skipping mutations.

2. How does the regulatory environment impact TABRECTA?
Timely approvals in Europe and Asia can significantly increase sales; delays curb growth.

3. Who are the main competitors to TABRECTA?
Tepmetko (tepotinib) by Ymabs and Savın (savatinib) by Eli Lilly.

4. What are the confidentiality restrictions on pricing?
Pricing varies by country and insurance coverage, with US prices averaging USD 15,000–20,000 monthly.

5. How is off-label use affecting revenues?
It can expand market size but lacks regulatory and clinical validation, posing revenue risks.

---

References

[1] Novartis. (2022). Annual Report 2022. Retrieved from https://www.novartis.com/investors/financial-results/annual-reports