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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 five patents protecting this drug.

This drug has one hundred and seventy-five patent family members in forty-four 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 will be eligible for patent challenges on May 6, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for TABRECTA

International Patents:	175
US Patents:	5
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

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
Novartis	Phase 2
Timothy Burns	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

Anatomical Therapeutic Chemical (ATC) Classes for TABRECTA

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TABRECTA

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

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TABRECTA

FDA Regulatory Exclusivity protecting TABRECTA

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

New Zealand

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
Singapore	10201900648S	TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE
Poland	2300455
France	22C1058
World Intellectual Property Organization (WIPO)	2009143211
European Patent Office	3172209	FORMULATION DE COMPRIMÉ DE 2-FLUORO-N-MÉTHYL-4-[7-(QUINOLINE -6-YLMÉTHYL) IMIDAZO[1,2-B][1,2,4]TRIAZINE -2-YL]BENZAMIDE (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE)

Supplementary Protection Certificates for TABRECTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3172209	51/2022	Austria		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
3172209	301208	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
2099447	2022C/557	Belgium		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621