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 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:	180
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
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	10,596,178		Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No

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

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
Cyprus	1119813
Taiwan	I724993
Poland	2099447
Israel	284889	אימידזוטריאזינים ואימידזופירימידינים כמעכבי קינאז (Imidazotriazines and imidazopyrimidines as kinase inhibitors)
Norway	20091924
Mexico	368802	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. (SALTS OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YL-METHYL)- IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE AND PROCESSES RELATED TO PREPARING THE SAME.)

Supplementary Protection Certificates for TABRECTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3172209	51/2022	Austria		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
3172209	2022C/558	Belgium		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621
2099447	CR 2022 00053	Denmark		PRODUCT NAME: CAPMATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
2099447	CA 2022 00053	Denmark		PRODUCT NAME: CAPMATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
2099447	2290050-0	Sweden		PRODUCT NAME: CAPMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/22/1650 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

Market Dynamics and Financial Trajectory for Tabrecta (Capmatinib)

Introduction to Tabrecta

Tabrecta, developed by Novartis, is a targeted therapy specifically designed for adult patients with metastatic non-small cell lung cancer (NSCLC) who have tumors with a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 (METex14) skipping. This drug has marked a significant milestone in the treatment of this specific patient subpopulation.

FDA Approval and Clinical Significance

Tabrecta received accelerated approval from the FDA in May 2020, based on the Phase II GEOMETRY mono-1 trial, which showed overall response rates (ORR) of 68% and 41%, and durations of response (DOR) of 12.6 and 9.7 months in treatment-naïve and previously treated patients, respectively[1].

In August 2022, the FDA converted this approval to a regular approval after 22 months of follow-up data from the same trial, reinforcing its efficacy and safety profile. The regular approval was based on additional data that showed an ORR of 68% and a DOR of 16.6 months in treatment-naïve patients, and an ORR of 44% with a DOR of 9.7 months in previously treated patients[1].

Market Position and Competition

Tabrecta has secured a first-to-market advantage in targeting the METex14 skipping mutation in NSCLC. According to GlobalData, Tabrecta is expected to maintain its market-leading position in the US, with forecasted sales reaching $372 million by 2028. This is significantly higher than its closest competitor, Merck’s Tepmetko, which is forecasted to reach $337 million by the same year[1].

Global Approval and Availability

In addition to its approval in the US, Tabrecta has been approved in several other countries. The European Commission approved Tabrecta for use in this patient subpopulation in June 2022, although only in the second-line setting[1].

Financial Performance

Since its launch, Tabrecta has shown promising financial performance. Initially launched with a list price of approximately $18,000 per month, Tabrecta generated $90 million in revenue in the fiscal year 2021. In the third quarter of 2023, Tabrecta sales remained stable, contributing $36 million to Novartis’s revenue[2].

Revenue Projections and Growth

GlobalData’s consensus analyst forecasts indicate that Tabrecta’s US sales will continue to grow, reaching $372 million by 2028. This growth is driven by its unique targeting mechanism and the lack of effective alternatives for patients with the METex14 skipping mutation[1].

Generic Competition

A potential challenge to Tabrecta’s market dominance could come from generic versions. Natco Pharma recently submitted an Abbreviated New Drug Application (ANDA) for a generic version of Tabrecta, which could impact Novartis’s revenue if approved[4].

Impact on Novartis’s Financials

Tabrecta’s performance is part of Novartis’s broader financial landscape. In the third quarter of 2023, Novartis reported a core operating income of $12.6 billion, with a margin of 36.9% of net sales. While Tabrecta’s sales were stable, the overall financial performance of Novartis was driven by higher sales across various product lines[2].

Patient and Market Impact

Lung cancer, particularly NSCLC, is a significant health burden globally, accounting for 82% of all lung cancer diagnoses in the US. The five-year survival rate for patients with localized NSCLC is 63%, but this drops to 35% and 7% for patients with regional or distant metastases, respectively. Tabrecta offers a critical treatment option for a subset of these patients, improving their survival rates and quality of life[1].

Expert Insights and Market Dynamics

Industry experts highlight the importance of targeted therapies like Tabrecta in addressing specific genetic mutations. "Tabrecta is the number one prescribed targeted therapy for this underserved patient subpopulation worldwide," according to GlobalData. This underscores the drug's market leadership and clinical significance[1].

Illustrative Statistics

• Approval and Efficacy: Tabrecta was approved based on an ORR of 68% and a DOR of 16.6 months in treatment-naïve patients, and an ORR of 44% with a DOR of 9.7 months in previously treated patients[1].
• Revenue Projections: Forecasted US sales of $372 million by 2028[1].
• Market Share: Expected to maintain its market-leading position against competitors like Merck’s Tepmetko[1].
• Global Reach: Approved in several countries, including the US and Europe[1].

Key Takeaways

• Targeted Therapy: Tabrecta is the first FDA-approved therapy targeting the METex14 skipping mutation in NSCLC.
• Market Leadership: Expected to maintain its market-leading position in the US.
• Financial Performance: Generated $90 million in revenue in FY21 and forecasted to reach $372 million by 2028.
• Global Approval: Approved in several countries, including the US and Europe.
• Generic Competition: Potential generic versions could impact future revenue.

Frequently Asked Questions (FAQs)

Q: What is Tabrecta used for? A: Tabrecta is used for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 (METex14) skipping.

Q: When did Tabrecta receive FDA approval? A: Tabrecta received accelerated FDA approval in May 2020 and was converted to a regular approval in August 2022.

Q: What are the efficacy rates of Tabrecta? A: Tabrecta showed an overall response rate (ORR) of 68% and a duration of response (DOR) of 16.6 months in treatment-naïve patients, and an ORR of 44% with a DOR of 9.7 months in previously treated patients.

Q: How does Tabrecta compare to its competitors? A: Tabrecta is expected to maintain its market-leading position in the US, with forecasted sales reaching $372 million by 2028, outpacing its closest competitor, Merck’s Tepmetko.

Q: Are there any generic versions of Tabrecta in development? A: Yes, Natco Pharma has submitted an Abbreviated New Drug Application (ANDA) for a generic version of Tabrecta.

Cited Sources

1. Clinical Trials Arena: FDA grants regular approval for Tabrecta use in NSCLC after follow-up data[1].
2. Novartis Q3 2023 Condensed Interim Financial Report: Financial performance and sales data for Tabrecta[2].
3. Incyte 2024 Third Quarter Financial and Corporate Update: Financial highlights and market dynamics[3].
4. Business Standard: Natco Pharma rises 4% after filing ANDA for generic lung cancer drug[4].