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.

The generic ingredient in TABRECTA is capmatinib hydrochloride. There is one drug master file entry for this compound. 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

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
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	8,461,330		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
Argentina	101286
Australia	2015293539
Australia	2018207947
Australia	2020200912
Australia	2021202500
Brazil	112017000953
Canada	2954840

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
2099447	CA 2022 00053	Denmark		PRODUCT NAME: CAPMATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/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	PA2022527	Lithuania		PRODUCT NAME: KAPMATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/22/1650 20220620
3172209	301208	Netherlands		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; 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
3172209	2022C/558	Belgium		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621

Tabrecta Market Dynamics, Financial Trajectory, Patent Protection, and Generic Entry Risk

Last updated: August 13, 2026

Tabrecta, Novartis’ capmatinib, is a targeted therapy for adults with metastatic non-small cell lung cancer whose tumors have MET exon 14 skipping alterations. Its commercial opportunity is constrained by the small biomarker-defined population, molecular testing requirements, competition from Tepmetko and other MET-directed therapies, and limited clinical use outside the approved indication. Novartis’ reported Tabrecta sales increased from an early launch base, but the product remains a small contributor to the company’s pharmaceutical revenue.

What is Tabrecta and which patients does it treat?

Tabrecta is an oral, selective MET inhibitor. The FDA approved it in May 2020 under the accelerated approval pathway for adults with metastatic NSCLC harboring MET exon 14 skipping alterations, based on overall response rate and duration of response in the GEOMETRY mono-1 study.[1]

The labeled population is defined by both disease stage and biomarker status:

Attribute	Tabrecta
Active ingredient	Capmatinib
Manufacturer	Novartis Pharmaceuticals
Drug class	Selective MET tyrosine kinase inhibitor
Dosage form	150 mg and 200 mg tablets
Standard dose	400 mg orally twice daily
FDA indication	Metastatic NSCLC with MET exon 14 skipping alteration
Diagnostic requirement	FDA-approved or cleared companion diagnostic testing
Initial FDA approval	May 6, 2020
Regulatory pathway	Accelerated approval
Principal trial	GEOMETRY mono-1
Competing branded therapy	Tepmetko, tepotinib, Merck KGaA/Eisai

MET exon 14 skipping alterations occur in approximately 3% to 4% of NSCLC cases, although prevalence varies by testing method, histology, age, and smoking history.[2] The addressable population is therefore much smaller than the broader EGFR-, ALK-, or KRAS-defined NSCLC markets.

How has Tabrecta revenue changed since launch?

Tabrecta sales grew after launch but remained modest relative to Novartis’ largest oncology products. Novartis reported approximately $29 million in sales in 2021, $44 million in 2022, and $67 million in 2023.[3-5]

Year	Reported Tabrecta sales	Approximate year-over-year change	Commercial interpretation
2020	Early launch contribution	Not meaningful	Initial U.S. launch during the COVID-19 period
2021	$29 million	Growth from launch base	Early biomarker adoption and market access development
2022	$44 million	Approximately 50%	Increased testing and treatment uptake
2023	$67 million	Approximately 50%	Continued growth, but from a narrow patient population

The revenue trajectory shows product adoption rather than blockbuster-scale commercialization. The main drivers were:

1. Increased identification of MET exon 14 skipping alterations through next-generation sequencing.
2. Broader use of tissue and liquid biopsy testing in metastatic NSCLC.
3. Physician familiarity with MET-directed treatment.
4. Expansion of first-line treatment use in patients with a confirmed alteration.
5. Novartis’ established oncology infrastructure.

The principal constraints were the low prevalence of the alteration, competition from Tepmetko, tolerability issues, and the limited duration of treatment in patients with advanced disease.

What is Tabrecta’s market size and commercial ceiling?

Tabrecta addresses a biomarker-defined segment rather than the entire NSCLC market. The commercial ceiling depends on four variables:

• The number of patients diagnosed with metastatic nonsquamous and squamous NSCLC.
• The share receiving comprehensive genomic profiling.
• The frequency of MET exon 14 skipping alterations.
• The proportion receiving targeted therapy rather than immunotherapy, chemotherapy, or another sequence of treatment.

The U.S. market is the most important commercial geography because of higher testing penetration, specialist oncology access, and reimbursement for molecular diagnostics. Europe and Japan contribute additional demand, but testing rates, treatment guidelines, and reimbursement differ by country.

The market is also concentrated among older patients. MET exon 14 skipping NSCLC is associated with an older patient population than several other oncogenic driver subsets. This can limit treatment duration and reduce the number of patients able to tolerate oral targeted therapy.

Tabrecta is unlikely to approach the scale of broad NSCLC products such as Keytruda, Tagrisso, or Alecensa unless the MET franchise expands into additional indications or earlier lines of treatment.

How does Tabrecta compare with Tepmetko?

Tepmetko is the most direct branded competitor. Both products target MET exon 14 skipping NSCLC and are oral MET inhibitors.

Category	Tabrecta	Tepmetko
Active ingredient	Capmatinib	Tepotinib
Originator	Novartis	Merck KGaA, with regional commercialization arrangements
FDA approval	2020	2021
Target	MET	MET
Key biomarker	MET exon 14 skipping alteration	MET exon 14 skipping alteration
Administration	Twice daily	Once daily
Commercial positioning	Strong early clinical evidence in MET exon 14 disease	Differentiation through once-daily dosing and VISION trial data
Principal competition	Tepmetko, chemotherapy, immunotherapy, clinical trials	Tabrecta and other MET-directed development programs

Clinical differentiation is limited because both products are used in the same narrow molecular population. Dosing convenience favors Tepmetko, while Tabrecta benefits from earlier market entry and Novartis’ oncology commercial platform.

Treatment selection can depend on prior therapy, comorbidities, hepatic function, edema risk, drug interactions, physician familiarity, and payer policy. Neither product has a market position comparable to the leading EGFR or ALK inhibitors.

What is the FDA regulatory status of Tabrecta?

The FDA granted accelerated approval based on a response rate of approximately 68% in treatment-naive patients and 41% in previously treated patients in GEOMETRY mono-1.[1] Median duration of response was approximately 12.6 months in treatment-naive patients and 9.7 months in previously treated patients.

The pivotal regulatory issue was the requirement for confirmatory evidence. Accelerated approval allows the FDA to approve a product based on a surrogate endpoint that is reasonably likely to predict clinical benefit. The sponsor must then complete postmarketing work that confirms benefit.

Novartis has continued to evaluate capmatinib in earlier-line and combination settings. The commercial importance of those studies is high because first-line use can increase treatment duration and patient volume. A failure to establish broader clinical utility would leave Tabrecta dependent on a small, biomarker-selected metastatic population.

When does Tabrecta lose exclusivity?

Tabrecta’s exclusivity profile has several components:

• FDA five-year new chemical entity exclusivity from the 2020 approval date.
• Orphan drug exclusivity may apply only if the approved indication received orphan designation and the statutory conditions are satisfied.
• U.S. patent protection covering capmatinib, pharmaceutical compositions, and methods of use.
• Regulatory exclusivity and patent rights in markets outside the United States.

The first five-year NCE exclusivity period expired in 2025. Patent expiry remains more important for generic entry.

The relevant patent estate is expected to include protection for the capmatinib molecule, pharmaceutical compositions, and use in MET-driven cancer. The effective U.S. loss-of-exclusivity date depends on the Orange Book-listed patents, patent term adjustment, patent term extension, pediatric exclusivity, and the outcome of any Paragraph IV litigation.

A precise launch date cannot be inferred from the FDA approval date alone. Generic applicants can file an ANDA with a Paragraph IV certification before patent expiry and may launch at risk if litigation does not produce an injunction or settlement restriction.

What patents protect Tabrecta?

Tabrecta protection is based primarily on small-molecule and method-of-use patents rather than biologic manufacturing rights.

Composition-of-matter protection

The strongest patent category generally covers capmatinib or a related compound series. Composition-of-matter claims are more difficult for a generic applicant to design around because an ANDA must contain the same active ingredient.

Formulation and pharmaceutical-composition protection

Additional claims may cover:

• Tablet compositions.
• Specific excipient combinations.
• Solid-state forms.
• Dosage strengths.
• Stability characteristics.
• Manufacturing processes for the active pharmaceutical ingredient or finished dosage form.

Formulation patents are generally less commercially decisive than composition-of-matter patents. An ANDA applicant may avoid some formulation claims by using a different excipient system or manufacturing process, although it must still demonstrate pharmaceutical equivalence.

Method-of-use patents

Method claims may cover treatment of MET exon 14 skipping NSCLC or other MET-dependent cancers. Their value depends on the scope of the claims and whether the FDA label includes the patented use.

Use patents can create litigation risk even when the active-ingredient patent is approaching expiry. Generic companies may attempt a section viii statement that omits the patented indication, provided the remaining label is commercially viable and the prescribing information does not induce infringement.

What is the Orange Book status of Tabrecta?

Tabrecta is an FDA-approved small-molecule prescription drug and is eligible for Orange Book patent listings. The Orange Book is the central reference for approved product patents and exclusivity, but listed patents do not guarantee that all claims will survive litigation or that generic entry will be blocked until the listed expiration date.[6]

The main Orange Book-related risks are:

• Paragraph IV challenges to listed patents.
• Declaratory judgment litigation.
• Patent-term calculations.
• Carve-outs for method-of-use claims.
• At-risk generic launches.
• Settlement agreements that delay entry without extending the practical life of every patent claim.

The branded product has no biosimilar pathway. Generic competition would proceed through the ANDA pathway, not through a 351(k) biosimilar application.

Which companies are challenging Tabrecta patents?

Publicly disclosed Paragraph IV activity and litigation should be tracked through FDA patent certifications, district court dockets, and the Orange Book. The commercial threat is likely to come from large generic manufacturers, including companies with established oncology ANDA capabilities, rather than from biosimilar developers.

A Paragraph IV challenge would create a 45-day period for the patent holder to file suit. If litigation is filed within that period, FDA approval may be subject to a 30-month stay, subject to court decisions and statutory exceptions.

The practical launch scenarios are:

Scenario	Likely commercial effect
No Paragraph IV filing	Generic entry near the final enforceable patent expiry
Paragraph IV settlement	Entry date determined by the agreement, often before the latest patent expiry
Novartis wins litigation	Entry delayed until patent expiry or a negotiated license
Generic wins litigation	Potential at-risk launch before patent expiry
Label carve-out	Competition may initially exclude a patented use
Multiple ANDA approvals	Rapid price erosion after the first generic

How strong is the Tabrecta patent estate?

The estate is commercially meaningful but narrower than the patent positions of products with multiple indications, formulations, delivery systems, and combination regimens.

Strengths include:

• A small-molecule composition-of-matter position.
• A defined biomarker-linked indication.
• FDA approval and clinical evidence supporting the labeled use.
• Potential method-of-use and formulation layers.
• The difficulty of substituting a different active ingredient in an ANDA.

Weaknesses include:

• A narrow patient population.
• Limited formulation differentiation.
• The absence of biologic manufacturing barriers.
• Potential use-label carve-outs.
• The ability of generic companies to challenge patents before expiry.
• Competitive substitution by Tepmetko and future MET inhibitors.

The estate’s value is therefore tied to the remaining patent term and the commercial persistence of capmatinib, not only to the number of listed patents.

What generic entry risks exist for Tabrecta?

Generic entry would likely produce a sharp price decline because oral oncology products are readily substituted when payer and pharmacy systems support generic dispensing. The first approved generic could capture substantial share quickly, particularly if Novartis has no authorized generic or favorable formulary position.

Entry risk is moderated by:

• The narrow MET exon 14 population.
• Lower expected generic revenue relative to high-volume oncology products.
• Potential complexity around bioequivalence for multiple strengths.
• Restricted distribution or specialty-pharmacy practices, if applicable.
• Physician preference for an established branded product in a precision-oncology setting.

Entry risk is increased by:

• A relatively simple oral tablet dosage form.
• The absence of biosimilar-style manufacturing complexity.
• A single, well-defined active ingredient.
• Payer pressure on branded oncology spending.
• The availability of molecular testing that identifies eligible patients.

What patent litigation and settlement issues affect Tabrecta?

Patent litigation risk will center on whether generic applicants can invalidate or avoid capmatinib composition, formulation, or method-of-use claims. Any settlement would need review under the FTC’s pharmaceutical patent-settlement framework and would have direct implications for the commercial launch date.

A settlement could include:

• A licensed generic entry date.
• Authorized-generic rights.
• Restrictions on launch before a specified date.
• No-challenge provisions.
• Supply or distribution terms.
• Allocation of risks relating to method-of-use claims.

No settlement should be treated as equivalent to a patent victory. The economic effect depends on the entry date, the number of generic licensees, and whether an authorized generic is launched.

What licensing deals support Tabrecta commercialization?

Tabrecta was developed by Incyte and later acquired by Novartis through an asset transaction. Novartis controls the global commercial franchise and has used its oncology infrastructure to develop and market capmatinib.[7]

The product does not depend on a broad external licensing network comparable to some partnered oncology drugs. Regional commercialization, distribution, and diagnostic relationships still matter because access requires identification of MET exon 14 skipping alterations.

What is the competitive outlook for MET-targeted NSCLC?

The market will remain competitive despite its small size. Key pressures include:

• Tepmetko in the same approved biomarker population.
• Combination trials involving MET inhibitors and immunotherapy.
• Next-generation MET inhibitors designed to address resistance.
• Broader liquid-biopsy adoption.
• Clinical trials for MET amplification and MET overexpression.
• Increasing use of comprehensive genomic profiling at diagnosis.

The largest potential growth lever is movement into first-line treatment and earlier disease settings. The largest downside risk is failure to demonstrate incremental value over existing targeted therapy or standard treatment sequences.

Key Takeaways

• Tabrecta is capmatinib, an oral MET inhibitor approved for metastatic NSCLC with MET exon 14 skipping alterations.
• Novartis sales increased from approximately $29 million in 2021 to $67 million in 2023.
• The commercial market is limited by the 3% to 4% prevalence of MET exon 14 alterations in NSCLC.
• Tepmetko is the principal direct branded competitor.
• FDA NCE exclusivity ended in 2025; patent expiry and Paragraph IV litigation now control the generic-entry analysis.
• Tabrecta is a small-molecule drug, so biosimilar risk does not apply.
• Composition-of-matter patents are likely the most important protection, with formulation and method-of-use patents providing additional layers.
• Generic entry would likely cause substantial price erosion, although the absolute revenue opportunity is limited by the narrow patient population.
• First-line expansion, testing penetration, and treatment duration are the central variables for future revenue growth.
• The product is commercially viable as a targeted niche therapy but has limited blockbuster potential without label expansion.

FAQs

Is Tabrecta a chemotherapy drug?

No. Tabrecta is an oral targeted therapy that inhibits MET signaling. It is used for NSCLC with a specific MET exon 14 skipping alteration.

Does Tabrecta require a companion diagnostic?

Yes. Patients must be identified through an FDA-approved or cleared test capable of detecting MET exon 14 skipping alterations.

Is there a generic version of Tabrecta?

No widely available generic version was identified in the cited regulatory and company materials. Future generic entry depends on ANDA filings, Orange Book patents, Paragraph IV litigation, and settlement terms.

Can Tabrecta be used for MET amplification?

The FDA-approved indication is for metastatic NSCLC with MET exon 14 skipping alterations. MET amplification alone is not the same biomarker and does not establish use under the approved label.

Does Tabrecta have biosimilar competition?

No. Capmatinib is a synthetic small molecule, so competition would arise through abbreviated new drug applications for generics rather than biosimilar applications.

References

1. U.S. Food and Drug Administration. (2020). FDA approves capmatinib for metastatic non-small cell lung cancer.
2. National Cancer Institute. (2023). MET exon 14 skipping alterations in non-small cell lung cancer.
3. Novartis. (2022). Annual report 2021.
4. Novartis. (2023). Annual report 2022.
5. Novartis. (2024). Annual report 2023.
6. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
7. Novartis. (2020). Novartis receives FDA approval for Tabrecta, the first and only therapy specifically designed for metastatic NSCLC with MET exon 14 skipping alterations.

DrugChatter Q&A for TABRECTA

Tabrecta?
Is tabrecta effective for met exon 14 skipping?